FHIR Server FHIR Server Version n/a

Resource StructureDefinition/FHIR Server from package hl7.fhir.us.pq-cmc-fda#current (1672 ms)

Package
hl7.fhir.us.pq-cmc-fda
Type
StructureDefinition
FHIR Version
Source
http://hl7.org/fhir/us/pq-cmc-fda/https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda/StructureDefinition-pqcmc-drug-product-substance-impurity.html
Url
http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity
Version
1.1.6
Status
active
Date
2024-09-17T03:56:09+00:00
Name
ImpuritySubstance
Title
Drug Substance Impurity
Experimental
False
Realm
Authority
hl7
Description
Any component of the drug substance that is not the chemical entity for procduct composition.
Type
SubstanceDefinition
Kind
resource
Resources that use this resource

StructureDefinition
cmc-ectd-document-32p55
CMC eCTD 32P55 Document
cmc-ectd-document-32s3
CMC eCTD 32S3 Document
pqcmc-drug-product-with-impurities
Drug Product Impurities
pqcmc-drug-substance-characterisation
Drug Substance
Resources that this resource uses

StructureDefinition
pqcmc-analytical-intstrument-data
Analytical Instrument Data
pqcmc-graphic-attachment
Analysis Graphic
pqcmc-graphic-reference
Graphic Reference
pqcmc-structure-reference
Structure Data Reference
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-impurity-classification-terminology
Impurity Classification Terminology
Narrative

Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition pqcmc-drug-product-substance-impurity
Name	Flags	Card.	Type	Description & Constraints
SubstanceDefinition	C	0..*	SubstanceDefinition	The detailed description of a substance, typically at a level beyond what is used for prescribing cmc-impurity-unii-required: If Product Impurity Chemical Structure Data File is not present, then a unii is required
meta
profile	S	0..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
identifier	S	0..1	Identifier	optional user designated identifier
classification	S	1..*	CodeableConcept	Impurity Classification Binding: Impurity Classification Terminology (required)
characterization	S	0..*	BackboneElement	General specifications for this substance
technique		0..1	CodeableConcept	The method used to find the characterization e.g. HPLC
text	S	1..1	string	Substance Characterisation Technique
description	S	0..1	markdown	Analysis Narrative Text and Table
Slices for file	S	0..*	Attachment	Impurity Analysis Graphic \| Impurity Analytical Instrument Data File Slice: Unordered, Open by profile:$this
file:AnalysisGraphic		0..*	GraphicAttachment	Analysis Graphic
file:AnalyticalInstrumentData		0..*	AnalyticalInstrumentData	Analytical Instrument Data File
structure	S	0..1	BackboneElement	Structural information
technique	S	0..*	CodeableConcept	Impurity Substance Characterisation Technique
text	S	1..1	string	Plain text representation of the concept
Slices for representation	S	0..*	BackboneElement	Impurity Structure Graphic \| Impurity Structure Data File Slice: Unordered, Closed by value:type.text
representation:graphic		0..1	BackboneElement	A graphical, displayable depiction of the structure (e.g. an SVG, PNG)
type	S	1..1	CodeableConcept	The kind of structural representation (e.g. full, partial)
text	S	1..1	string	Plain text representation of the concept Required Pattern: Graphics
document		1..1	Reference(Graphic Reference)	Impurity Structure Graphic
representation:structureData		0..*	BackboneElement	machine-readable representation -- may be plain text (e.g. SMILES) or an attached file (e.g. SDF)
type	S	1..1	CodeableConcept	The kind of structural representation (e.g. full, partial)
text	S	1..1	string	Plain text representation of the concept Required Pattern: Structure
representation	S	0..1	string	Impurity Chemical Structure Data (short, plain text representations, e.g. SMILES)
format	S	0..1	CodeableConcept	Drug Substance Impurity Method Type
text	S	0..1	string	Plain text representation of the concept
document	S	0..1	Reference(Structure Data Reference)	Impurity Chemical Structure Data (large files, e.g. SDF, CIF)
Slices for code	S	0..*	BackboneElement	Codes associated with the substance Slice: Unordered, Open by value:code.coding.system
code:unii		0..1	BackboneElement	UNII
code	S	1..1	CodeableConcept	The specific code
coding	S	1..1	Coding	Code defined by a terminology system
system	S	1..1	uri	Identity of the terminology system Required Pattern: http://fdasis.nlm.nih.gov
code:uniProt		0..1	BackboneElement	UniProt ID
code	S	1..1	CodeableConcept	The specific code
coding	S	1..1	Coding	Code defined by a terminology system
system	S	1..1	uri	Identity of the terminology system Required Pattern: https://www.uniprot.org
Slices for name	SC	1..*	BackboneElement	Substance Name Slice: Unordered, Closed by value:type.coding cmc-name-preferred: Name.preferred: at most one = true
name:All Slices				Content/Rules for all slices
preferred	S	0..1	boolean	True when the name type is Substance Name
name:sub	S	0..1	BackboneElement	Names applicable to this substance
name	S	1..1	string	Generic Name
type	S	1..1	CodeableConcept	Name type e.g. 'systematic', 'scientific, 'brand'
coding	S	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C97054
display		1..1	string	Representation defined by the system Fixed Value: Generic Name
preferred	S	0..1	boolean	If this is the preferred name for this substance
name:gsrs	S	0..1	BackboneElement	Names applicable to this substance
name	S	1..1	string	GSRS Preferred Term
type	S	1..1	CodeableConcept	Name type e.g. 'systematic', 'scientific, 'brand'
coding	S	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C203355
display		1..1	string	Representation defined by the system Fixed Value: GSRS Preferred Term
preferred	S	0..1	boolean	If this is the preferred name for this substance
name:isbt	S	0..1	BackboneElement	Names applicable to this substance
name	S	1..1	string	ISBT-128 DIN
type	S	1..1	CodeableConcept	Name type e.g. 'systematic', 'scientific, 'brand'
coding	S	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C95517
display		1..1	string	Representation defined by the system Fixed Value: ISBT-128 DIN
preferred	S	0..1	boolean	If this is the preferred name for this substance
name:comp	S	0..1	BackboneElement	Names applicable to this substance
name	S	1..1	string	Company ID/Code
type	S	1..1	CodeableConcept	Name type e.g. 'systematic', 'scientific, 'brand'
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C203354
display		1..1	string	Representation defined by the system Fixed Value: Company ID/Code
Documentation for this format
Source

{
  "resourceType" : "StructureDefinition",
  "id" : "pqcmc-drug-product-substance-impurity",
  "text" : {
    "status" : "extensions",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: StructureDefinition pqcmc-drug-product-substance-impurity</b></p><a name=\"pqcmc-drug-product-substance-impurity\"> </a><a name=\"hcpqcmc-drug-product-substance-impurity\"> </a><a name=\"pqcmc-drug-product-substance-impurity-en-US\"> </a><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;\"><tr style=\"border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top\"><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"The logical name of the element\">Name</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Information about the use of the element\">Flags</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Minimum and Maximum # of times the element can appear in the instance\">Card.</a></th><th style=\"width: 100px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Reference to the type of the element\">Type</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Additional information about the element\">Description &amp; Constraints</a><span style=\"float: right\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/></a></span></th></tr><tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_resource.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition\">SubstanceDefinition</a><a name=\"SubstanceDefinition\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;\" href=\"http://hl7.org/fhir/R5/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( cmc-impurity-unii-required )\">C</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/substancedefinition.html\">SubstanceDefinition</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The detailed description of a substance, typically at a level beyond what is used for prescribing</span><br/><span style=\"font-weight:bold\">cmc-impurity-unii-required: </span>If Product Impurity Chemical Structure Data File is not present, then a unii is required</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.meta\">meta</a><a name=\"SubstanceDefinition.meta\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.meta.profile\">profile</a><a name=\"SubstanceDefinition.meta.profile\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span>..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">canonical</a>(<a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/structuredefinition.html\">StructureDefinition</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Profiles this resource claims to conform to</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.identifier\">identifier</a><a name=\"SubstanceDefinition.identifier\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span>..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Identifier\">Identifier</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">optional user designated identifier</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.classification\" title=\"A categorization of impurities based on its origin. [Source: SME Defined]\nExamples: Degradation Product, Inorganic, Process Related/Process, Product Related, Leachables.\">classification</a><a name=\"SubstanceDefinition.classification\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Impurity Classification<br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-impurity-classification-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-impurity-classification-terminology\">Impurity Classification Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.characterization\">characterization</a><a name=\"SubstanceDefinition.characterization\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">General specifications for this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.characterization.technique\" title=\"The technique used to elucidate the structure ore characterization of the drug substance. [Source: SME Defined]\nExamples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay, etc.\">technique</a><a name=\"SubstanceDefinition.characterization.technique\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The method used to find the characterization e.g. HPLC</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.characterization.technique.text\">text</a><a name=\"SubstanceDefinition.characterization.technique.text\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Substance Characterisation Technique</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.characterization.description\">description</a><a name=\"SubstanceDefinition.characterization.description\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#markdown\">markdown</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Analysis Narrative Text and Table</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> <a style=\"font-style: italic\" href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.characterization.file\">Slices for file</a><a name=\"SubstanceDefinition.characterization.file\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\"/><span style=\"opacity: 0.5; font-style: italic\">0</span><span style=\"opacity: 0.5; font-style: italic\">..</span><span style=\"opacity: 0.5; font-style: italic\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; font-style: italic\" href=\"http://hl7.org/fhir/R5/datatypes.html#Attachment\">Attachment</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\">Impurity Analysis Graphic | Impurity Analytical Instrument Data File</span><br style=\"font-style: italic\"/><span style=\"font-weight:bold; font-style: italic\">Slice: </span><span style=\"font-style: italic\">Unordered, Open by profile:$this</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1034.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.characterization.file:AnalysisGraphic\" title=\"Slice AnalysisGraphic: Analysis Graphic: The pictorial representation of the data. [Source: SME Defined] Examples: spectrum, chromatogram.\nNote: Refer to the 'Acceptable File Formats for use in eCTD'\nExample: This is the representation of the instrumental output for the molecule -- CH3OHA pictorial representation of the structure of the drug substance. Required for Small Molecules. [Source: SME Defined]\">file:AnalysisGraphic</a><a name=\"SubstanceDefinition.characterization.file.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"StructureDefinition-pqcmc-graphic-attachment.html\" title=\"Attachment\">GraphicAttachment</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Analysis Graphic<br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1024.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.characterization.file:AnalyticalInstrumentData\" title=\"Slice AnalyticalInstrumentData: Impurity Analytical Instrument Data File: The transport format for data exchange. [Source: SME Defined]\nExample: JCAMP, ADX, ADF.\">file:AnalyticalInstrumentData</a><a name=\"SubstanceDefinition.characterization.file.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"StructureDefinition-pqcmc-analytical-intstrument-data.html\" title=\"Attachment\">AnalyticalInstrumentData</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Analytical Instrument Data File<br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure\">structure</a><a name=\"SubstanceDefinition.structure\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Structural information</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure.technique\" title=\"The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.\">technique</a><a name=\"SubstanceDefinition.structure.technique\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Impurity Substance Characterisation Technique</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure.technique.text\">text</a><a name=\"SubstanceDefinition.structure.technique.text\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> <a style=\"font-style: italic\" href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure.representation\">Slices for representation</a><a name=\"SubstanceDefinition.structure.representation\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\"/><span style=\"opacity: 0.5; font-style: italic\">0</span><span style=\"opacity: 0.5; font-style: italic\">..</span><span style=\"opacity: 0.5; font-style: italic\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; font-style: italic\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\">Impurity Structure Graphic | Impurity Structure Data File</span><br style=\"font-style: italic\"/><span style=\"font-weight:bold; font-style: italic\">Slice: </span><span style=\"font-style: italic\">Unordered, Closed by value:type.text</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1035.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure.representation:graphic\" title=\"Slice graphic\">representation:graphic</a><a name=\"SubstanceDefinition.structure.representation.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">A graphical, displayable depiction of the structure (e.g. an SVG, PNG)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure.representation:graphic.type\">type</a><a name=\"SubstanceDefinition.structure.representation.type\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The kind of structural representation (e.g. full, partial)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure.representation:graphic.type.text\">text</a><a name=\"SubstanceDefinition.structure.representation.type.text\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Graphics</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_reference.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Reference to another Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure.representation:graphic.document\" title=\"A pictorial representation of the structure of the impurity substance. \n[Source: SME Defined] Note: Refer to the 'Acceptable File Formats for \nuse in eCTD' Example: This is the representation of the molecule CH3OH, \nor the sequence SHLVEALALVAGERG.\">document</a><a name=\"SubstanceDefinition.structure.representation.document\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">Reference</a>(<a href=\"StructureDefinition-pqcmc-graphic-reference.html\">Graphic Reference</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Impurity Structure Graphic</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1025.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure.representation:structureData\" title=\"Slice structureData\">representation:structureData</a><a name=\"SubstanceDefinition.structure.representation.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">machine-readable representation -- may be plain text (e.g. SMILES) or an attached file (e.g. SDF)<br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10251.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure.representation:structureData.type\">type</a><a name=\"SubstanceDefinition.structure.representation.type.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The kind of structural representation (e.g. full, partial)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck102500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure.representation:structureData.type.text\">text</a><a name=\"SubstanceDefinition.structure.representation.type.text.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Structure</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10250.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure.representation:structureData.representation\" title=\"A machine-readable representation of the structure of the chemical. [Source: SME Defined]\nExamples: Structured Data File (SDF), MOLFILE, InChI file (small molecule), PDB, mmCIF (large molecules), HELM.\">representation</a><a name=\"SubstanceDefinition.structure.representation.representation\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Impurity Chemical Structure Data (short, plain text representations, e.g. SMILES)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10251.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure.representation:structureData.format\">format</a><a name=\"SubstanceDefinition.structure.representation.format\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Drug Substance Impurity Method Type</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck102500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure.representation:structureData.format.text\">text</a><a name=\"SubstanceDefinition.structure.representation.format.text\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10240.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_reference.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Reference to another Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure.representation:structureData.document\">document</a><a name=\"SubstanceDefinition.structure.representation.document.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">Reference</a>(<a href=\"StructureDefinition-pqcmc-structure-reference.html\">Structure Data Reference</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Impurity Chemical Structure Data (large files, e.g. SDF, CIF)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> <a style=\"font-style: italic\" href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.code\">Slices for code</a><a name=\"SubstanceDefinition.code\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\"/><span style=\"opacity: 0.5; font-style: italic\">0</span><span style=\"opacity: 0.5; font-style: italic\">..</span><span style=\"opacity: 0.5; font-style: italic\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; font-style: italic\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5; font-style: italic\">Codes associated with the substance</span><br style=\"font-style: italic\"/><span style=\"font-weight:bold; font-style: italic\">Slice: </span><span style=\"font-style: italic\">Unordered, Open by value:code.coding.system</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.code:unii\" title=\"Slice unii: The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substanceâ€™s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/]\nExample: 362O9ITL9D\nNote: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/\">code:unii</a><a name=\"SubstanceDefinition.code.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">UNII</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1341.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.code:unii.code\">code</a><a name=\"SubstanceDefinition.code.code\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The specific code</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13401.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.code:unii.code.coding\">coding</a><a name=\"SubstanceDefinition.code.code.coding\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.code:unii.code.coding.system\">system</a><a name=\"SubstanceDefinition.code.code.coding.system\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Identity of the terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">http://fdasis.nlm.nih.gov</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.code:uniProt\" title=\"Slice uniProt: The  UniProt ID is an index to the UniProt knowledgebase,  a large resource of protein sequences and associated detailed annotation.\nIt is accessible at https://www.uniprot.org/\">code:uniProt</a><a name=\"SubstanceDefinition.code.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">UniProt ID</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1241.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.code:uniProt.code\">code</a><a name=\"SubstanceDefinition.code.code.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The specific code</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck12401.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.code:uniProt.code.coding\">coding</a><a name=\"SubstanceDefinition.code.code.coding.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck124000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.code:uniProt.code.coding.system\">system</a><a name=\"SubstanceDefinition.code.code.coding.system.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Identity of the terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">https://www.uniprot.org</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck03.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> <a style=\"font-style: italic\" href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name\" title=\"Substance Name is identified by its Substance Type.\nSubstance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined]\nExamples: GSRS Preferred Term, Systematic Name, INN, USP/NF\">Slices for name</a><a name=\"SubstanceDefinition.name\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic\" title=\"This element must be supported\">S</span><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; font-style: italic\" href=\"http://hl7.org/fhir/R5/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( cmc-name-preferred )\">C</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\"/><span style=\"font-style: italic\">1</span><span style=\"font-style: italic\">..</span><span style=\"opacity: 0.5; font-style: italic\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; font-style: italic\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\">Substance Name</span><br style=\"font-style: italic\"/><span style=\"font-weight:bold; font-style: italic\">Slice: </span><span style=\"font-style: italic\">Unordered, Closed by value:type.coding</span><br style=\"font-style: italic\"/><span style=\"font-weight:bold; font-style: italic\">cmc-name-preferred: </span><span style=\"font-style: italic\">Name.preferred: at most one = true</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck033.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> name:All Slices<a name=\"SubstanceDefinition.name.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Content/Rules for all slices</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0320.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name.preferred\">preferred</a><a name=\"SubstanceDefinition.name.preferred\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">True when the name type is Substance Name</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck035.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:sub\" title=\"Slice sub\">name:sub</a><a name=\"SubstanceDefinition.name.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Names applicable to this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:sub.name\" title=\"A non-branded nor registered name that meant for common use.\">name</a><a name=\"SubstanceDefinition.name.name\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Generic Name</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:sub.type\">type</a><a name=\"SubstanceDefinition.name.type\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Name type e.g. 'systematic',  'scientific, 'brand'</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck03501.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:sub.type.coding\">coding</a><a name=\"SubstanceDefinition.name.type.coding\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">At least the following</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck035010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system\">system</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Identity of the terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck035010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Symbol in syntax defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">C97054</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck035000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Representation defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">Generic Name</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:sub.preferred\">preferred</a><a name=\"SubstanceDefinition.name.preferred.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">If this is the preferred name for this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck035.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:gsrs\" title=\"Slice gsrs\">name:gsrs</a><a name=\"SubstanceDefinition.name.4\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Names applicable to this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:gsrs.name\" title=\"Default display name identified within FDA Global Substance Registration System (GSRS).\">name</a><a name=\"SubstanceDefinition.name.name.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">GSRS Preferred Term</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:gsrs.type\">type</a><a name=\"SubstanceDefinition.name.type.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Name type e.g. 'systematic',  'scientific, 'brand'</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck03501.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:gsrs.type.coding\">coding</a><a name=\"SubstanceDefinition.name.type.coding.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">At least the following</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck035010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system\">system</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Identity of the terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck035010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Symbol in syntax defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">C203355</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck035000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Representation defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">GSRS Preferred Term</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:gsrs.preferred\">preferred</a><a name=\"SubstanceDefinition.name.preferred.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">If this is the preferred name for this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck035.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:isbt\" title=\"Slice isbt\">name:isbt</a><a name=\"SubstanceDefinition.name.5\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Names applicable to this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:isbt.name\" title=\"It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]\">name</a><a name=\"SubstanceDefinition.name.name.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">ISBT-128 DIN</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:isbt.type\">type</a><a name=\"SubstanceDefinition.name.type.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Name type e.g. 'systematic',  'scientific, 'brand'</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck03501.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:isbt.type.coding\">coding</a><a name=\"SubstanceDefinition.name.type.coding.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">At least the following</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck035010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system\">system</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Identity of the terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck035010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Symbol in syntax defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">C95517</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck035000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Representation defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">ISBT-128 DIN</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:isbt.preferred\">preferred</a><a name=\"SubstanceDefinition.name.preferred.4\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">If this is the preferred name for this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck025.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:comp\" title=\"Slice comp\">name:comp</a><a name=\"SubstanceDefinition.name.6\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Names applicable to this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0250.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:comp.name\" title=\"An internal identifier assigned by the sponsor to this drug substance. [Source: SME Defined]\">name</a><a name=\"SubstanceDefinition.name.name.4\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Company ID/Code</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0241.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:comp.type\">type</a><a name=\"SubstanceDefinition.name.type.4\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Name type e.g. 'systematic',  'scientific, 'brand'</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck02401.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.name:comp.type.coding\">coding</a><a name=\"SubstanceDefinition.name.type.coding.4\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">At least the following</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck024010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system\">system</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Identity of the terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck024010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Symbol in syntax defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">C203354</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck024000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Representation defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">Company ID/Code</span></td></tr>\r\n<tr><td colspan=\"5\" class=\"hierarchy\"><br/><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table></div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode" : "brr"
    }
  ],
  "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity",
  "identifier" : [
    {
      "system" : "urn:ietf:rfc:3986",
      "value" : "urn:oid:2.16.840.1.113883.4.642.40.36.42.44"
    }
  ],
  "version" : "1.1.6",
  "name" : "ImpuritySubstance",
  "title" : "Drug Substance Impurity",
  "status" : "active",
  "date" : "2024-09-17T03:56:09+00:00",
  "publisher" : "HL7 International / Biomedical Research and Regulation",
  "contact" : [
    {
      "name" : "HL7 International / Biomedical Research and Regulation",
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://www.hl7.org/Special/committees/rcrim"
        },
        {
          "system" : "email",
          "value" : "brr@lists.HL7.org"
        }
      ]
    }
  ],
  "description" : "Any component of the drug substance that is not the chemical entity for procduct composition.",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "urn:iso:std:iso:3166",
          "code" : "US",
          "display" : "United States of America"
        }
      ]
    }
  ],
  "fhirVersion" : "5.0.0",
  "mapping" : [
    {
      "identity" : "w5",
      "uri" : "http://hl7.org/fhir/fivews",
      "name" : "FiveWs Pattern Mapping"
    },
    {
      "identity" : "idmp-substance",
      "uri" : "https://www.iso.org/obp/ui/#iso:std:iso:11238",
      "name" : "IDMP Mapping (Substance)"
    },
    {
      "identity" : "rim",
      "uri" : "http://hl7.org/v3",
      "name" : "RIM Mapping"
    }
  ],
  "kind" : "resource",
  "abstract" : false,
  "type" : "SubstanceDefinition",
  "baseDefinition" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition",
  "derivation" : "constraint",
  "snapshot" : {
    "element" : [
      {
        "id" : "SubstanceDefinition",
        "path" : "SubstanceDefinition",
        "short" : "The detailed description of a substance, typically at a level beyond what is used for prescribing",
        "definition" : "The detailed description of a substance, typically at a level beyond what is used for prescribing.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition",
          "min" : 0,
          "max" : "*"
        },
        "constraint" : [
          {
            "key" : "dom-2",
            "severity" : "error",
            "human" : "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
            "expression" : "contained.contained.empty()",
            "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
          },
          {
            "key" : "dom-3",
            "severity" : "error",
            "human" : "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource",
            "expression" : "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()",
            "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
          },
          {
            "key" : "dom-4",
            "severity" : "error",
            "human" : "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
            "expression" : "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
            "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
          },
          {
            "key" : "dom-5",
            "severity" : "error",
            "human" : "If a resource is contained in another resource, it SHALL NOT have a security label",
            "expression" : "contained.meta.security.empty()",
            "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
          },
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
                "valueBoolean" : true
              },
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
                "valueMarkdown" : "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
              }
            ],
            "key" : "dom-6",
            "severity" : "warning",
            "human" : "A resource should have narrative for robust management",
            "expression" : "text.`div`.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
          },
          {
            "key" : "cmc-impurity-unii-required",
            "severity" : "error",
            "human" : "If Product Impurity Chemical Structure Data File is not present, then a unii is required",
            "expression" : "structure.representation.where(type.text = 'Structure' and document.exists()).exists().not() implies (\n  code.where(\n    code.coding.system = 'http://fdasis.nlm.nih.gov'\n  ).exists()\n)",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "Entity, Role, or Act"
          },
          {
            "identity" : "w5",
            "map" : "administrative.medication"
          },
          {
            "identity" : "idmp-substance",
            "map" : "Substance (and derived classes: Chemical, Polymer, Protein, Nucleic_Acid, Structurally_Diverse)"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.id",
        "path" : "SubstanceDefinition.id",
        "short" : "Logical id of this artifact",
        "definition" : "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
        "comment" : "Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.meta",
        "path" : "SubstanceDefinition.meta",
        "short" : "Metadata about the resource",
        "definition" : "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.meta",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Meta"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.meta.id",
        "path" : "SubstanceDefinition.meta.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.meta.extension",
        "path" : "SubstanceDefinition.meta.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.meta.versionId",
        "path" : "SubstanceDefinition.meta.versionId",
        "short" : "Version specific identifier",
        "definition" : "The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.",
        "comment" : "The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Meta.versionId",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "id"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.meta.lastUpdated",
        "path" : "SubstanceDefinition.meta.lastUpdated",
        "short" : "When the resource version last changed",
        "definition" : "When the resource last changed - e.g. when the version changed.",
        "comment" : "This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a [read](http://hl7.org/fhir/R5/http.html#read) interaction.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Meta.lastUpdated",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "instant"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.meta.source",
        "path" : "SubstanceDefinition.meta.source",
        "short" : "Identifies where the resource comes from",
        "definition" : "A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](provenance.html#) information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.",
        "comment" : "The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference. \n\nThis element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Meta.source",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.meta.profile",
        "path" : "SubstanceDefinition.meta.profile",
        "short" : "Profiles this resource claims to conform to",
        "definition" : "A list of profiles (references to [StructureDefinition](structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](structuredefinition-definitions.html#StructureDefinition.url).",
        "comment" : "It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time.  The list of profile URLs is a set.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Meta.profile",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "canonical",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/StructureDefinition"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.meta.security",
        "path" : "SubstanceDefinition.meta.security",
        "short" : "Security Labels applied to this resource",
        "definition" : "Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.",
        "comment" : "The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Meta.security",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SecurityLabels"
            }
          ],
          "strength" : "extensible",
          "description" : "Security Labels from the Healthcare Privacy and Security Classification System.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/security-labels"
        }
      },
      {
        "id" : "SubstanceDefinition.meta.tag",
        "path" : "SubstanceDefinition.meta.tag",
        "short" : "Tags applied to this resource",
        "definition" : "Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.",
        "comment" : "The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Meta.tag",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Tags"
            }
          ],
          "strength" : "example",
          "description" : "Codes that represent various types of tags, commonly workflow-related; e.g. \"Needs review by Dr. Jones\".",
          "valueSet" : "http://hl7.org/fhir/ValueSet/common-tags"        "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.modifierExtension",
        "path" : "SubstanceDefinition.moiety.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.role",
        "path" : "SubstanceDefinition.moiety.role",
        "short" : "Role that the moiety is playing",
        "definition" : "Role that the moiety is playing.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.role",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Moiety.Moiety_Role"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.identifier",
        "path" : "SubstanceDefinition.moiety.identifier",
        "short" : "Identifier by which this moiety substance is known",
        "definition" : "Identifier by which this moiety substance is known.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.identifier",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Identifier"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Moiety.Moiety_Id"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.name",
        "path" : "SubstanceDefinition.moiety.name",
        "short" : "Textual name for this moiety substance",
        "definition" : "Textual name for this moiety substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.name",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Moiety.Moiety_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.stereochemistry",
        "path" : "SubstanceDefinition.moiety.stereochemistry",
        "short" : "Stereochemistry type",
        "definition" : "Stereochemistry type.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.stereochemistry",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceStereochemistry"
            }
          ],
          "strength" : "example",
          "description" : "The optical rotation type of a substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-stereochemistry"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Moiety.Stereochemistry"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.opticalActivity",
        "path" : "SubstanceDefinition.moiety.opticalActivity",
        "short" : "Optical activity type",
        "definition" : "Optical activity type.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.opticalActivity",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceOpticalActivity"
            }
          ],
          "strength" : "example",
          "description" : "The optical rotation type of a substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-optical-activity"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Moiety.Optical_Activity"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.molecularFormula",
        "path" : "SubstanceDefinition.moiety.molecularFormula",
        "short" : "Molecular formula for this moiety (e.g. with the Hill system)",
        "definition" : "Molecular formula for this moiety of this substance, typically using the Hill system.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.molecularFormula",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Moiety.Molecular_Formula"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.amount[x]",
        "path" : "SubstanceDefinition.moiety.amount[x]",
        "short" : "Quantitative value for this moiety",
        "definition" : "Quantitative value for this moiety.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.amount[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Quantity"
          },
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Moiety.Amount"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.measurementType",
        "path" : "SubstanceDefinition.moiety.measurementType",
        "short" : "The measurement type of the quantitative value",
        "definition" : "The measurement type of the quantitative value. In capturing the actual relative amounts of substances or molecular fragments it may be necessary to indicate whether the amount refers to, for example, a mole ratio or weight ratio.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.measurementType",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceAmountType"
            }
          ],
          "strength" : "example",
          "description" : "The relationship between two substance types.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-amount-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Amount.Amount_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization",
        "path" : "SubstanceDefinition.characterization",
        "short" : "General specifications for this substance",
        "definition" : "General specifications for this substance.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.characterization",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.id",
        "path" : "SubstanceDefinition.characterization.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.extension",
        "path" : "SubstanceDefinition.characterization.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.modifierExtension",
        "path" : "SubstanceDefinition.characterization.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.technique",
        "path" : "SubstanceDefinition.characterization.technique",
        "short" : "The method used to find the characterization e.g. HPLC",
        "definition" : "The technique used to elucidate the structure ore characterization of the drug substance. [Source: SME Defined]\nExamples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay, etc.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.characterization.technique",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceStructureTechnique"
            }
          ],
          "strength" : "example",
          "description" : "The method used to elucidate the characterization of the drug substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-structure-technique"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.technique.id",
        "path" : "SubstanceDefinition.characterization.technique.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.technique.extension",
        "path" : "SubstanceDefinition.characterization.technique.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.technique.coding",
        "path" : "SubstanceDefinition.characterization.technique.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.technique.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "SubstanceDefinition.characterization.technique.text",
        "short" : "Substance Characterisation Technique",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.form",
        "path" : "SubstanceDefinition.characterization.form",
        "short" : "Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form",
        "definition" : "Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.characterization.form",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceForm"
            }
          ],
          "strength" : "example",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-form"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.description",
        "path" : "SubstanceDefinition.characterization.description",
        "short" : "Analysis Narrative Text and Table",
        "definition" : "The description or justification in support of the interpretation of the data file.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.characterization.description",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "markdown"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.file",
        "path" : "SubstanceDefinition.characterization.file",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "profile",
              "path" : "$this"
            }
          ],
          "ordered" : false,
          "rules" : "open"
        },
        "short" : "Impurity Analysis Graphic | Impurity Analytical Instrument Data File",
        "definition" : "The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.characterization.file",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Attachment"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.file:AnalysisGraphic",
        "path" : "SubstanceDefinition.characterization.file",
        "sliceName" : "AnalysisGraphic",
        "short" : "Analysis Graphic",
        "definition" : "Analysis Graphic: The pictorial representation of the data. [Source: SME Defined] Examples: spectrum, chromatogram.\nNote: Refer to the 'Acceptable File Formats for use in eCTD'\nExample: This is the representation of the instrumental output for the molecule -- CH3OHA pictorial representation of the structure of the drug substance. Required for Small Molecules. [Source: SME Defined]",
        "comment" : "When providing a summary view (for example with Observation.value[x]) Attachment should be represented with a brief display text such as \"Signed Procedure Consent\".",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.characterization.file",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Attachment",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-attachment"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "att-1",
            "severity" : "error",
            "human" : "If the Attachment has data, it SHALL have a contentType",
            "expression" : "data.empty() or contentType.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Attachment"
          },
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a,ED"
          },
          {
            "identity" : "v2",
            "map" : "ED/RP"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.file:AnalyticalInstrumentData",
        "path" : "SubstanceDefinition.characterization.file",
        "sliceName" : "AnalyticalInstrumentData",
        "short" : "Analytical Instrument Data File",
        "definition" : "Impurity Analytical Instrument Data File: The transport format for data exchange. [Source: SME Defined]\nExample: JCAMP, ADX, ADF.",
        "comment" : "When providing a summary view (for example with Observation.value[x]) Attachment should be represented with a brief display text such as \"Signed Procedure Consent\".",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.characterization.file",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Attachment",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-analytical-intstrument-data"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "att-1",
            "severity" : "error",
            "human" : "If the Attachment has data, it SHALL have a contentType",
            "expression" : "data.empty() or contentType.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Attachment"
          },
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a,ED"
          },
          {
            "identity" : "v2",
            "map" : "ED/RP"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.property",
        "path" : "SubstanceDefinition.property",
        "short" : "General specifications for this substance",
        "definition" : "General specifications for this substance.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Property"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.property.id",
        "path" : "SubstanceDefinition.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.property.extension",
        "path" : "SubstanceDefinition.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.property.modifierExtension",
        "path" : "SubstanceDefinition.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.property.type",
        "path" : "SubstanceDefinition.property.type",
        "short" : "A code expressing the type of property",
        "definition" : "A code expressing the type of property.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Property.Property_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.property.value[x]",
        "path" : "SubstanceDefinition.property.value[x]",
        "short" : "A value for the property",
        "definition" : "A value for the property.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          },
          {
            "code" : "Quantity"
          },
          {
            "code" : "date"
          },
          {
            "code" : "boolean"
          },
          {
            "code" : "Attachment"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.referenceInformation",
        "path" : "SubstanceDefinition.referenceInformation",
        "short" : "General information detailing this substance",
        "definition" : "General information detailing this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.referenceInformation",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/SubstanceReferenceInformation"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Reference_Information"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.molecularWeight",
        "path" : "SubstanceDefinition.molecularWeight",
        "short" : "The average mass of a molecule of a compound",
        "definition" : "The average mass of a molecule of a compound compared to 1/12 the mass of carbon 12 and calculated as the sum of the atomic weights of the constituent atoms.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.molecularWeight",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.molecularWeight.id",
        "path" : "SubstanceDefinition.molecularWeight.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.molecularWeight.extension",
        "path" : "SubstanceDefinition.molecularWeight.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.molecularWeight.modifierExtension",
        "path" : "SubstanceDefinition.molecularWeight.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.molecularWeight.method",
        "path" : "SubstanceDefinition.molecularWeight.method",
        "short" : "The method by which the weight was determined",
        "definition" : "The method by which the molecular weight was determined.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.molecularWeight.method",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceWeightMethod"
            }
          ],
          "strength" : "example",
          "description" : "The method by which the substance weight was measured.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-weight-method"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Molecular_Weight.Molecular_Weight_Method"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.molecularWeight.type",
        "path" : "SubstanceDefinition.molecularWeight.type",
        "short" : "Type of molecular weight e.g. exact, average, weight average",
        "definition" : "Type of molecular weight such as exact, average (also known as. number average), weight average.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.molecularWeight.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceWeightType"
            }
          ],
          "strength" : "example",
          "description" : "The type of substance weight measurement.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-weight-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Molecular_Weight.Molecular_Weight_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.molecularWeight.amount",
        "path" : "SubstanceDefinition.molecularWeight.amount",
        "short" : "Used to capture quantitative values for a variety of elements",
        "definition" : "Used to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.molecularWeight.amount",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Quantity"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Molecular_Weight.Amount"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure",
        "path" : "SubstanceDefinition.structure",
        "short" : "Structural information",
        "definition" : "Structural information.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.structure",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Structure"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.id",
        "path" : "SubstanceDefinition.structure.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.extension",
        "path" : "SubstanceDefinition.structure.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.modifierExtension",
        "path" : "SubstanceDefinition.structure.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.stereochemistry",
        "path" : "SubstanceDefinition.structure.stereochemistry",
        "short" : "Stereochemistry type",
        "definition" : "Stereochemistry type.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.structure.stereochemistry",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceStereochemistry"
            }
          ],
          "strength" : "example",
          "description" : "The optical rotation type of a substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-stereochemistry"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Structure.Stereochemistry"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.opticalActivity",
        "path" : "SubstanceDefinition.structure.opticalActivity",
        "short" : "Optical activity type",
        "definition" : "Optical activity type.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.structure.opticalActivity",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceOpticalActivity"
            }
          ],
          "strength" : "example",
          "description" : "The optical rotation type of a substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-optical-activity"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Structure.Optical_Activity"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.molecularFormula",
        "path" : "SubstanceDefinition.structure.molecularFormula",
        "short" : "An expression which states the number and type of atoms present in a molecule of a substance",
        "definition" : "An expression which states the number and type of atoms present in a molecule of a substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.structure.molecularFormula",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Structure.Molecular_Formula"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.molecularFormulaByMoiety",
        "path" : "SubstanceDefinition.structure.molecularFormulaByMoiety",
        "short" : "Specified per moiety according to the Hill system",
        "definition" : "Specified per moiety according to the Hill system, i.e. first C, then H, then alphabetical, each moiety separated by a dot.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.structure.molecularFormulaByMoiety",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Structure.Molecular_Formula_By_Moiety"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.molecularWeight",
        "path" : "SubstanceDefinition.structure.molecularWeight",
        "short" : "The molecular weight or weight range",
        "definition" : "The molecular weight or weight range (for proteins, polymers or nucleic acids).",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.structure.molecularWeight",
          "min" : 0,
          "max" : "1"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.molecularWeight",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Structure.Molecular_Weight"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.technique",
        "path" : "SubstanceDefinition.structure.technique",
        "short" : "Impurity Substance Characterisation Technique",
        "definition" : "The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.structure.technique",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceStructureTechnique"
            }
          ],
          "strength" : "example",
          "description" : "The method used to elucidate the structure of the drug substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-structure-technique"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.technique.id",
        "path" : "SubstanceDefinition.structure.technique.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.technique.extension",
        "path" : "SubstanceDefinition.structure.technique.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.technique.coding",
        "path" : "SubstanceDefinition.structure.technique.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.technique.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "SubstanceDefinition.structure.technique.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.sourceDocument",
        "path" : "SubstanceDefinition.structure.sourceDocument",
        "short" : "Source of information for the structure",
        "definition" : "The source of information about the structure.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.structure.sourceDocument",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Structure.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.representation",
        "path" : "SubstanceDefinition.structure.representation",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "type.text"
            }
          ],
          "ordered" : false,
          "rules" : "closed"
        },
        "short" : "Impurity Structure Graphic | Impurity Structure Data File",
        "definition" : "A depiction of the structure of the substance.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.structure.representation",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Structure.Structural_Representation"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.representation.id",
        "path" : "SubstanceDefinition.structure.representation.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.representation.extension",
        "path" : "SubstanceDefinition.structure.representation.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.representation.modifierExtension",
        "path" : "SubstanceDefinition.structure.representation.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.representation.type",
        "path" : "SubstanceDefinition.structure.representation.type",
        "short" : "The kind of structural representation (e.g. full, partial)",
        "definition" : "The kind of structural representation (e.g. full, partial).",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.structure.representation.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceRepresentationType"
            }
          ],
          "strength" : "example",
          "description" : "A format of a substance representation.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-representation-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Structural_Representation.Structural_Representation_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.representation.representation",
        "path" : "SubstanceDefinition.structure.representation.representation",
        "short" : "The structural representation as a text string in a standard format",
        "definition" : "The structural representation as a text string in a standard format.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.structure.representation.representation",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Structural_Representation.Structural_Representation"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.representation.format",
        "path" : "SubstanceDefinition.structure.representation.format",
        "short" : "The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)",
        "definition" : "The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.structure.representation.format",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceRepresentationFormat"
            }
          ],
          "strength" : "example",
          "description" : "A format of a substance representation.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-representation-format"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.representation.document",
        "path" : "SubstanceDefinition.structure.representation.document",
        "short" : "An attachment with the structural representation e.g. a structure graphic or AnIML file",
        "definition" : "An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.structure.representation.document",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "m what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())      "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameDomain"
            }
          ],
          "strength" : "example",
          "description" : "The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-domain"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Domain"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.jurisdiction",
        "path" : "SubstanceDefinition.name.jurisdiction",
        "short" : "The jurisdiction where this name applies",
        "definition" : "The jurisdiction where this name applies.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.jurisdiction",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Jurisdiction"
            }
          ],
          "strength" : "example",
          "description" : "Jurisdiction codes",
          "valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Jurisdiction"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.synonym",
        "path" : "SubstanceDefinition.name.synonym",
        "short" : "A synonym of this particular name, by which the substance is also known",
        "definition" : "A synonym of this particular name, by which the substance is also known.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.synonym",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.translation",
        "path" : "SubstanceDefinition.name.translation",
        "short" : "A translation for this name into another human language",
        "definition" : "A translation for this name into another human language.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.translation",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.official",
        "path" : "SubstanceDefinition.name.official",
        "short" : "Details of the official nature of this name",
        "definition" : "Details of the official nature of this name.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.official",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Official_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.official.id",
        "path" : "SubstanceDefinition.name.official.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.official.extension",
        "path" : "SubstanceDefinition.name.official.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.official.modifierExtension",
        "path" : "SubstanceDefinition.name.official.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.official.authority",
        "path" : "SubstanceDefinition.name.official.authority",
        "short" : "Which authority uses this official name",
        "definition" : "Which authority uses this official name.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.authority",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameAuthority"
            }
          ],
          "strength" : "preferred",
          "description" : "An authority that officates substance names.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-authority"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.official.status",
        "path" : "SubstanceDefinition.name.official.status",
        "short" : "The status of the official name, for example 'draft', 'active'",
        "definition" : "The status of the official name, for example 'draft', 'active', 'retired'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.official.date",
        "path" : "SubstanceDefinition.name.official.date",
        "short" : "Date of official name change",
        "definition" : "Date of the official name change.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.date",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status_Change_Date"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.source",
        "path" : "SubstanceDefinition.name.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "sub",
        "short" : "Names applicable to this substance",
        "definition" : "Names applicable to this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.id",
        "path" : "SubstanceDefinition.name.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.extension",
        "path" : "SubstanceDefinition.name.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.modifierExtension",
        "path" : "SubstanceDefinition.name.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "Generic Name",
        "definition" : "A non-branded nor registered name that meant for common use.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.name",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.type",
        "path" : "SubstanceDefinition.name.type",
        "short" : "Name type e.g. 'systematic',  'scientific, 'brand'",
        "definition" : "Name type, for example 'systematic',  'scientific, 'brand'.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameType"
            }
          ],
          "strength" : "example",
          "description" : "The type of a name given to a substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.type.id",
        "path" : "SubstanceDefinition.name.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.type.extension",
        "path" : "SubstanceDefinition.name.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.type.coding",
        "path" : "SubstanceDefinition.name.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "patternCoding" : {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C97054",
          "display" : "Generic Name"
        },
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "SubstanceDefinition.name.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.status",
        "path" : "SubstanceDefinition.name.status",
        "short" : "The status of the name e.g. 'current', 'proposed'",
        "definition" : "The status of the name, for example 'current', 'proposed'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "short" : "If this is the preferred name for this substance",
        "definition" : "If this is the preferred name for this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.preferred",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.language",
        "path" : "SubstanceDefinition.name.language",
        "short" : "Human language that the name is written in",
        "definition" : "Human language that the name is written in.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.language",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Language"
            }
          ],
          "strength" : "required",
          "description" : "IETF language tag for a human language",
          "valueSet" : "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
          "additional" : [
            {
              "purpose" : "starter",
              "valueSet" : "http://hl7.org/fhir/ValueSet/languages"
            }
          ]
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Language"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.domain",
        "path" : "SubstanceDefinition.name.domain",
        "short" : "The use context of this name e.g. as an active ingredient or as a food colour additive",
        "definition" : "The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.domain",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameDomain"
            }
          ],
          "strength" : "example",
          "description" : "The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-domain"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Domain"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.jurisdiction",
        "path" : "SubstanceDefinition.name.jurisdiction",
        "short" : "The jurisdiction where this name applies",
        "definition" : "The jurisdiction where this name applies.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.jurisdiction",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Jurisdiction"
            }
          ],
          "strength" : "example",
          "description" : "Jurisdiction codes",
          "valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Jurisdiction"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.synonym",
        "path" : "SubstanceDefinition.name.synonym",
        "short" : "A synonym of this particular name, by which the substance is also known",
        "definition" : "A synonym of this particular name, by which the substance is also known.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.synonym",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.translation",
        "path" : "SubstanceDefinition.name.translation",
        "short" : "A translation for this name into another human language",
        "definition" : "A translation for this name into another human language.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.translation",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.official",
        "path" : "SubstanceDefinition.name.official",
        "short" : "Details of the official nature of this name",
        "definition" : "Details of the official nature of this name.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.official",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Official_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.official.id",
        "path" : "SubstanceDefinition.name.official.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.official.extension",
        "path" : "SubstanceDefinition.name.official.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.official.modifierExtension",
        "path" : "SubstanceDefinition.name.official.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.official.authority",
        "path" : "SubstanceDefinition.name.official.authority",
        "short" : "Which authority uses this official name",
        "definition" : "Which authority uses this official name.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.authority",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameAuthority"
            }
          ],
          "strength" : "preferred",
          "description" : "An authority that officates substance names.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-authority"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.official.status",
        "path" : "SubstanceDefinition.name.official.status",
        "short" : "The status of the official name, for example 'draft', 'active'",
        "definition" : "The status of the official name, for example 'draft', 'active', 'retired'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.official.date",
        "path" : "SubstanceDefinition.name.official.date",
        "short" : "Date of official name change",
        "definition" : "Date of the official name change.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.date",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status_Change_Date"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.source",
        "path" : "SubstanceDefinition.name.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "gsrs",
        "short" : "Names applicable to this substance",
        "definition" : "Names applicable to this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.id",
        "path" : "SubstanceDefinition.name.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.extension",
        "path" : "SubstanceDefinition.name.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.modifierExtension",
        "path" : "SubstanceDefinition.name.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "GSRS Preferred Term",
        "definition" : "Default display name identified within FDA Global Substance Registration System (GSRS).",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.name",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type",
        "path" : "SubstanceDefinition.name.type",
        "short" : "Name type e.g. 'systematic',  'scientific, 'brand'",
        "definition" : "Name type, for example 'systematic',  'scientific, 'brand'.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameType"
            }
          ],
          "strength" : "example",
          "description" : "The type of a name given to a substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type.id",
        "path" : "SubstanceDefinition.name.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type.extension",
        "path" : "SubstanceDefinition.name.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type.coding",
        "path" : "SubstanceDefinition.name.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "patternCoding" : {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C203355",
          "display" : "GSRS Preferred Term"
        },
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "SubstanceDefinition.name.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.status",
        "path" : "SubstanceDefinition.name.status",
        "short" : "The status of the name e.g. 'current', 'proposed'",
        "definition" : "The status of the name, for example 'current', 'proposed'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "short" : "If this is the preferred name for this substance",
        "definition" : "If this is the preferred name for this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.preferred",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.language",
        "path" : "SubstanceDefinition.name.language",
        "short" : "Human language that the name is written in",
        "definition" : "Human language that the name is written in.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.language",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Language"
            }
          ],
          "strength" : "required",
          "description" : "IETF language tag for a human language",
          "valueSet" : "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
          "additional" : [
            {
              "purpose" : "starter",
              "valueSet" : "http://hl7.org/fhir/ValueSet/languages"
            }
          ]
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Language"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.domain",
        "path" : "SubstanceDefinition.name.domain",
        "short" : "The use context of this name e.g. as an active ingredient or as a food colour additive",
        "definition" : "The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.domain",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameDomain"
            }
          ],
          "strength" : "example",
          "description" : "The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-domain"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Domain"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.jurisdiction",
        "path" : "SubstanceDefinition.name.jurisdiction",
        "short" : "The jurisdiction where this name applies",
        "definition" : "The jurisdiction where this name applies.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.jurisdiction",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Jurisdiction"
            }
          ],
          "strength" : "example",
          "description" : "Jurisdiction codes",
          "valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Jurisdiction"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.synonym",
        "path" : "SubstanceDefinition.name.synonym",
        "short" : "A synonym of this particular name, by which the substance is also known",
        "definition" : "A synonym of this particular name, by which the substance is also known.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.synonym",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.translation",
        "path" : "SubstanceDefinition.name.translation",
        "short" : "A translation for this name into another human language",
        "definition" : "A translation for this name into another human language.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.translation",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official",
        "path" : "SubstanceDefinition.name.official",
        "short" : "Details of the official nature of this name",
        "definition" : "Details of the official nature of this name.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.official",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Official_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.id",
        "path" : "SubstanceDefinition.name.official.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.extension",
        "path" : "SubstanceDefinition.name.official.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.modifierExtension",
        "path" : "SubstanceDefinition.name.official.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.authority",
        "path" : "SubstanceDefinition.name.official.authority",
        "short" : "Which authority uses this official name",
        "definition" : "Which authority uses this official name.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.authority",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameAuthority"
            }
          ],
          "strength" : "preferred",
          "description" : "An authority that officates substance names.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-authority"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.status",
        "path" : "SubstanceDefinition.name.official.status",
        "short" : "The status of the official name, for example 'draft', 'active'",
        "definition" : "The status of the official name, for example 'draft', 'active', 'retired'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.date",
        "path" : "SubstanceDefinition.name.official.date",
        "short" : "Date of official name change",
        "definition" : "Date of the official name change.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.date",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status_Change_Date"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.source",
        "path" : "SubstanceDefinition.name.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "isbt",
        "short" : "Names applicable to this substance",
        "definition" : "Names applicable to this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.id",
        "path" : "SubstanceDefinition.name.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.extension",
        "path" : "SubstanceDefinition.name.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.modifierExtension",
        "path" : "SubstanceDefinition.name.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "ISBT-128 DIN",
        "definition" : "It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.name",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type",
        "path" : "SubstanceDefinition.name.type",
        "short" : "Name type e.g. 'systematic',  'scientific, 'brand'",
        "definition" : "Name type, for example 'systematic',  'scientific, 'brand'.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameType"
            }
          ],
          "strength" : "example",
          "description" : "The type of a name given to a substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type.id",
        "path" : "SubstanceDefinition.name.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type.extension",
        "path" : "SubstanceDefinition.name.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type.coding",
        "path" : "SubstanceDefinition.name.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "patternCoding" : {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C95517",
          "display" : "ISBT-128 DIN"
        },
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "SubstanceDefinition.name.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.status",
        "path" : "SubstanceDefinition.name.status",
        "short" : "The status of the name e.g. 'current', 'proposed'",
        "definition" : "The status of the name, for example 'current', 'proposed'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "short" : "If this is the preferred name for this substance",
        "definition" : "If this is the preferred name for this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.preferred",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.language",
        "path" : "SubstanceDefinition.name.language",
        "short" : "Human language that the name is written in",
        "definition" : "Human language that the name is written in.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.language",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Language"
            }
          ],
          "strength" : "required",
          "description" : "IETF language tag for a human language",
          "valueSet" : "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
          "additional" : [
            {
              "purpose" : "starter",
              "valueSet" : "http://hl7.org/fhir/ValueSet/languages"
            }
          ]
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Language"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.domain",
        "path" : "SubstanceDefinition.name.domain",
        "short" : "The use context of this name e.g. as an active ingredient or as a food colour additive",
        "definition" : "The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.domain",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameDomain"
            }
          ],
          "strength" : "example",
          "description" : "The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-domain"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Domain"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.jurisdiction",
        "path" : "SubstanceDefinition.name.jurisdiction",
        "short" : "The jurisdiction where this name applies",
        "definition" : "The jurisdiction where this name applies.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.jurisdiction",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Jurisdiction"
            }
          ],
          "strength" : "example",
          "description" : "Jurisdiction codes",
          "valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Jurisdiction"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.synonym",
        "path" : "SubstanceDefinition.name.synonym",
        "short" : "A synonym of this particular name, by which the substance is also known",
        "definition" : "A synonym of this particular name, by which the substance is also known.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.synonym",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.translation",
        "path" : "SubstanceDefinition.name.translation",
        "short" : "A translation for this name into another human language",
        "definition" : "A translation for this name into another human language.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.translation",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official",
        "path" : "SubstanceDefinition.name.official",
        "short" : "Details of the official nature of this name",
        "definition" : "Details of the official nature of this name.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.official",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Official_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.id",
        "path" : "SubstanceDefinition.name.official.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.extension",
        "path" : "SubstanceDefinition.name.official.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.modifierExtension",
        "path" : "SubstanceDefinition.name.official.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.authority",
        "path" : "SubstanceDefinition.name.official.authority",
        "short" : "Which authority uses this official name",
        "definition" : "Which authority uses this official name.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.authority",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameAuthority"
            }
          ],
          "strength" : "preferred",
          "description" : "An authority that officates substance names.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-authority"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.status",
        "path" : "SubstanceDefinition.name.official.status",
        "short" : "The status of the official name, for example 'draft', 'active'",
        "definition" : "The status of the official name, for example 'draft', 'active', 'retired'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.date",
        "path" : "SubstanceDefinition.name.official.date",
        "short" : "Date of official name change",
        "definition" : "Date of the official name change.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.date",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status_Change_Date"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.source",
        "path" : "SubstanceDefinition.name.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "comp",
        "short" : "Names applicable to this substance",
        "definition" : "Names applicable to this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.id",
        "path" : "SubstanceDefinition.name.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.extension",
        "path" : "SubstanceDefinition.name.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.modifierExtension",
        "path" : "SubstanceDefinition.name.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "Company ID/Code",
        "definition" : "An internal identifier assigned by the sponsor to this drug substance. [Source: SME Defined]",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.name",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.type",
        "path" : "SubstanceDefinition.name.type",
        "short" : "Name type e.g. 'systematic',  'scientific, 'brand'",
        "definition" : "Name type, for example 'systematic',  'scientific, 'brand'.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameType"
            }
          ],
          "strength" : "example",
          "description" : "The type of a name given to a substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.type.id",
        "path" : "SubstanceDefinition.name.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.type.extension",
        "path" : "SubstanceDefinition.name.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.type.coding",
        "path" : "SubstanceDefinition.name.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "patternCoding" : {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C203354",
          "display" : "Company ID/Code"
        },
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "SubstanceDefinition.name.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.status",
        "path" : "SubstanceDefinition.name.status",
        "short" : "The status of the name e.g. 'current', 'proposed'",
        "definition" : "The status of the name, for example 'current', 'proposed'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "short" : "If this is the preferred name for this substance",
        "definition" : "If this is the preferred name for this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.preferred",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.language",
        "path" : "SubstanceDefinition.name.language",
        "short" : "Human language that the name is written in",
        "definition" : "Human language that the name is written in.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.language",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Language"
            }
          ],
          "strength" : "required",
          "description" : "IETF language tag for a human language",
          "valueSet" : "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
          "additional" : [
            {
              "purpose" : "starter",
              "valueSet" : "http://hl7.org/fhir/ValueSet/languages"
            }
          ]
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Language"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.domain",
        "path" : "SubstanceDefinition.name.domain",
        "short" : "The use context of this name e.g. as an active ingredient or as a food colour additive",
        "definition" : "The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.domain",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameDomain"
            }
          ],
          "strength" : "example",
          "description" : "The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-domain"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Domain"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.jurisdiction",
        "path" : "SubstanceDefinition.name.jurisdiction",
        "short" : "The jurisdiction where this name applies",
        "definition" : "The jurisdiction where this name applies.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.jurisdiction",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Jurisdiction"
            }
          ],
          "strength" : "example",
          "description" : "Jurisdiction codes",
          "valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Jurisdiction"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.synonym",
        "path" : "SubstanceDefinition.name.synonym",
        "short" : "A synonym of this particular name, by which the substance is also known",
        "definition" : "A synonym of this particular name, by which the substance is also known.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.synonym",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.translation",
        "path" : "SubstanceDefinition.name.translation",
        "short" : "A translation for this name into another human language",
        "definition" : "A translation for this name into another human language.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.translation",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.official",
        "path" : "SubstanceDefinition.name.official",
        "short" : "Details of the official nature of this name",
        "definition" : "Details of the official nature of this name.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.official",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Official_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.official.id",
        "path" : "SubstanceDefinition.name.official.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.official.extension",
        "path" : "SubstanceDefinition.name.official.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.official.modifierExtension",
        "path" : "SubstanceDefinition.name.official.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.official.authority",
        "path" : "SubstanceDefinition.name.official.authority",
        "short" : "Which authority uses this official name",
        "definition" : "Which authority uses this official name.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.authority",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameAuthority"
            }
          ],
          "strength" : "preferred",
          "description" : "An authority that officates substance names.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-authority"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.official.status",
        "path" : "SubstanceDefinition.name.official.status",
        "short" : "The status of the official name, for example 'draft', 'active'",
        "definition" : "The status of the official name, for example 'draft', 'active', 'retired'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.official.date",
        "path" : "SubstanceDefinition.name.official.date",
        "short" : "Date of official name change",
        "definition" : "Date of the official name change.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.date",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status_Change_Date"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:comp.source",
        "path" : "SubstanceDefinition.name.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship",
        "path" : "SubstanceDefinition.relationship",
        "short" : "A link between this substance and another",
        "definition" : "A link between this substance and another, with details of the relationship.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.relationship",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Reference_Information.Relationship"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.id",
        "path" : "SubstanceDefinition.relationship.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.extension",
        "path" : "SubstanceDefinition.relationship.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.modifierExtension",
        "path" : "SubstanceDefinition.relationship.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.substanceDefinition[x]",
        "path" : "SubstanceDefinition.relationship.substanceDefinition[x]",
        "short" : "A pointer to another substance, as a resource or a representational code",
        "definition" : "A pointer to another substance, as a resource or just a representational code.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.substanceDefinition[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"
            ]
          },
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Related_Substance_Id"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.type",
        "path" : "SubstanceDefinition.relationship.type",
        "short" : "For example \"salt to parent\", \"active moiety\"",
        "definition" : "For example \"salt to parent\", \"active moiety\", \"starting material\", \"polymorph\", \"impurity of\".",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceRelationshipType"
            }
          ],
          "strength" : "example",
          "description" : "The relationship between two substance types.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-relationship-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Relationship_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.isDefining",
        "path" : "SubstanceDefinition.relationship.isDefining",
        "short" : "For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships",
        "definition" : "For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible substance relationships.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.isDefining",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is a defining relationship or not. No inference can be made",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Is_Defining"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.amount[x]",
        "path" : "SubstanceDefinition.relationship.amount[x]",
        "short" : "A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other",
        "definition" : "A numeric factor for the relationship, for instance to express that the salt of a substance has some percentage of the active substance in relation to some other.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.amount[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Quantity"
          },
          {
            "code" : "Ratio"
          },
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Amount.Quantity"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.ratioHighLimitAmount",
        "path" : "SubstanceDefinition.relationship.ratioHighLimitAmount",
        "short" : "For use when the numeric has an uncertain range",
        "definition" : "For use when the numeric has an uncertain range.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.ratioHighLimitAmount",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Ratio"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Amount.Quantity.High_Limit"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.comparator",
        "path" : "SubstanceDefinition.relationship.comparator",
        "short" : "An operator for the amount, for example \"average\", \"approximately\", \"less than\"",
        "definition" : "An operator for the amount, for example \"average\", \"approximately\", \"less than\".",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.comparator",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceAmountType"
            }
          ],
          "strength" : "example",
          "description" : "The relationship between two substance types.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-amount-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Amount_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.source",
        "path" : "SubstanceDefinition.relationship.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.relationship.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.nucleicAcid",
        "path" : "SubstanceDefinition.nucleicAcid",
        "short" : "Data items specific to nucleic acids",
        "definition" : "Data items specific to nucleic acids.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.nucleicAcid",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/SubstanceNucleicAcid"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "(used to add specifics of Nucleic Acids to Substances)"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.polymer",
        "path" : "SubstanceDefinition.polymer",
        "short" : "Data items specific to polymers",
        "definition" : "Data items specific to polymers.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.polymer",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/SubstancePolymer"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "(used to  add specifics of Polymers to Substances)"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.protein",
        "path" : "SubstanceDefinition.protein",
        "short" : "Data items specific to proteins",
        "definition" : "Data items specific to proteins.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.protein",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/SubstanceProtein"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "(used to  add specifics of Proteins to Substances)"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial",
        "path" : "SubstanceDefinition.sourceMaterial",
        "short" : "Material or taxonomic/anatomical source",
        "definition" : "Material or taxonomic/anatomical source for the substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.sourceMaterial",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Source_Material"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.id",
        "path" : "SubstanceDefinition.sourceMaterial.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.extension",
        "path" : "SubstanceDefinition.sourceMaterial.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.modifierExtension",
        "path" : "SubstanceDefinition.sourceMaterial.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.type",
        "path" : "SubstanceDefinition.sourceMaterial.type",
        "short" : "Classification of the origin of the raw material. e.g. cat hair is an Animal source type",
        "definition" : "A classification that provides the origin of the raw material. Example: cat hair would be an Animal source type.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.sourceMaterial.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SourceMaterialType"
            }
          ],
          "strength" : "example",
          "description" : "A classification that provides the origin of the substance raw material.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-source-material-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Source_Material.Source_Material_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.genus",
        "path" : "SubstanceDefinition.sourceMaterial.genus",
        "short" : "The genus of an organism e.g. the Latin epithet of the plant/animal scientific name",
        "definition" : "The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.sourceMaterial.genus",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SourceMaterialGenus"
            }
          ],
          "strength" : "example",
          "description" : "The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-source-material-genus"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Source_Material.Organism.Genus"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.species",
        "path" : "SubstanceDefinition.sourceMaterial.species",
        "short" : "The species of an organism e.g. the Latin epithet of the species of the plant/animal",
        "definition" : "The species of an organism, typically referring to the Latin epithet of the species of the plant/animal.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.sourceMaterial.species",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SourceMaterialSpecies"
            }
          ],
          "strength" : "example",
          "description" : "A species of origin a substance raw material.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-source-material-species"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Source_Material.Organism.Species"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.part",
        "path" : "SubstanceDefinition.sourceMaterial.part",
        "short" : "An anatomical origin of the source material within an organism",
        "definition" : "An anatomical origin of the source material within an organism.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.sourceMaterial.part",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SourceMaterialPart"
            }
          ],
          "strength" : "example",
          "description" : "An anatomical origin of the source material within an organism.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-source-material-part"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Source_Material.Part_Description.Part"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.countryOfOrigin",
        "path" : "SubstanceDefinition.sourceMaterial.countryOfOrigin",
        "short" : "The country or countries where the material is harvested",
        "definition" : "The country or countries where the material is harvested.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.sourceMaterial.countryOfOrigin",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Country"
            }
          ],
          "strength" : "required",
          "description" : "Jurisdiction codes",
          "valueSet" : "http://hl7.org/fhir/ValueSet/country|5.0.0"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Source_Material.Country_Of_Origin"
          }
        ]
      }
    ]
  },
  "differential" : {
    "element" : [
      {
        "id" : "SubstanceDefinition",
        "path" : "SubstanceDefinition",
        "constraint" : [
          {
            "key" : "cmc-impurity-unii-required",
            "severity" : "error",
            "human" : "If Product Impurity Chemical Structure Data File is not present, then a unii is required",
            "expression" : "structure.representation.where(type.text = 'Structure' and document.exists()).exists().not() implies (\n  code.where(\n    code.coding.system = 'http://fdasis.nlm.nih.gov'\n  ).exists()\n)",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.meta.profile",
        "path" : "SubstanceDefinition.meta.profile",
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.identifier",
        "path" : "SubstanceDefinition.identifier",
        "short" : "optional user designated identifier",
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.classification",
        "path" : "SubstanceDefinition.classification",
        "short" : "Impurity Classification",
        "definition" : "A categorization of impurities based on its origin. [Source: SME Defined]\nExamples: Degradation Product, Inorganic, Process Related/Process, Product Related, Leachables.",
        "min" : 1,
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-impurity-classification-terminology"
        }
      },
      {
        "id" : "SubstanceDefinition.characterization",
        "path" : "SubstanceDefinition.characterization",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.characterization.technique",
        "path" : "SubstanceDefinition.characterization.technique",
        "definition" : "The technique used to elucidate the structure ore characterization of the drug substance. [Source: SME Defined]\nExamples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay, etc."
      },
      {
        "id" : "SubstanceDefinition.characterization.technique.text",
        "path" : "SubstanceDefinition.characterization.technique.text",
        "short" : "Substance Characterisation Technique",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.characterization.description",
        "path" : "SubstanceDefinition.characterization.description",
        "short" : "Analysis Narrative Text and Table",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.characterization.file",
        "path" : "SubstanceDefinition.characterization.file",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "profile",
              "path" : "$this"
            }
          ],
          "ordered" : false,
          "rules" : "open"
        },
        "short" : "Impurity Analysis Graphic | Impurity Analytical Instrument Data File",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.characterization.file:AnalysisGraphic",
        "path" : "SubstanceDefinition.characterization.file",
        "sliceName" : "AnalysisGraphic",
        "short" : "Analysis Graphic",
        "definition" : "Analysis Graphic: The pictorial representation of the data. [Source: SME Defined] Examples: spectrum, chromatogram.\nNote: Refer to the 'Acceptable File Formats for use in eCTD'\nExample: This is the representation of the instrumental output for the molecule -- CH3OHA pictorial representation of the structure of the drug substance. Required for Small Molecules. [Source: SME Defined]",
        "min" : 0,
        "max" : "*",
        "type" : [
          {
            "code" : "Attachment",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-attachment"
            ]
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.file:AnalyticalInstrumentData",
        "path" : "SubstanceDefinition.characterization.file",
        "sliceName" : "AnalyticalInstrumentData",
        "short" : "Analytical Instrument Data File",
        "definition" : "Impurity Analytical Instrument Data File: The transport format for data exchange. [Source: SME Defined]\nExample: JCAMP, ADX, ADF.",
        "min" : 0,
        "max" : "*",
        "type" : [
          {
            "code" : "Attachment",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-analytical-intstrument-data"
            ]
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure",
        "path" : "SubstanceDefinition.structure",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.structure.technique",
        "path" : "SubstanceDefinition.structure.technique",
        "short" : "Impurity Substance Characterisation Technique",
        "definition" : "The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.structure.technique.text",
        "path" : "SubstanceDefinition.structure.technique.text",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.structure.representation",
        "path" : "SubstanceDefinition.structure.representation",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "type.text"
            }
          ],
          "ordered" : false,
          "rules" : "closed"
        },
        "short" : "Impurity Structure Graphic | Impurity Structure Data File",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.structure.representation:graphic",
        "path" : "SubstanceDefinition.structure.representation",
        "sliceName" : "graphic",
        "short" : "A graphical, displayable depiction of the structure (e.g. an SVG, PNG)",
        "min" : 0,
        "max" : "1"
      },
      {
        "id" : "SubstanceDefinition.structure.representation:graphic.type",
        "path" : "SubstanceDefinition.structure.representation.type",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.structure.representation:graphic.type.text",
        "path" : "SubstanceDefinition.structure.representation.type.text",
        "min" : 1,
        "patternString" : "Graphics",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.structure.representation:graphic.document",
        "path" : "SubstanceDefinition.structure.representation.document",
        "short" : "Impurity Structure Graphic",
        "definition" : "A pictorial representation of the structure of the impurity substance. \n[Source: SME Defined] Note: Refer to the 'Acceptable File Formats for \nuse in eCTD' Example: This is the representation of the molecule CH3OH, \nor the sequence SHLVEALALVAGERG.",
        "min" : 1,
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference"
            ]
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.representation:structureData",
        "path" : "SubstanceDefinition.structure.representation",
        "sliceName" : "structureData",
        "short" : "machine-readable representation -- may be plain text (e.g. SMILES) or an attached file (e.g. SDF)",
        "min" : 0,
        "max" : "*"
      },
      {
        "id" : "SubstanceDefinition.structure.representation:structureData.type",
        "path" : "SubstanceDefinition.structure.representation.type",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.structure.representation:structureData.type.text",
        "path" : "SubstanceDefinition.structure.representation.type.text",
        "min" : 1,
        "patternString" : "Structure",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.structure.representation:structureData.representation",
        "path" : "SubstanceDefinition.structure.representation.representation",
        "short" : "Impurity Chemical Structure Data (short, plain text representations, e.g. SMILES)",
        "definition" : "A machine-readable representation of the structure of the chemical. [Source: SME Defined]\nExamples: Structured Data File (SDF), MOLFILE, InChI file (small molecule), PDB, mmCIF (large molecules), HELM.",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.structure.representation:structureData.format",
        "path" : "SubstanceDefinition.structure.representation.format",
        "short" : "Drug Substance Impurity Method Type",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.structure.representation:structureData.format.text",
        "path" : "SubstanceDefinition.structure.representation.format.text",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.structure.representation:structureData.document",
        "path" : "SubstanceDefinition.structure.representation.document",
        "short" : "Impurity Chemical Structure Data (large files, e.g. SDF, CIF)",
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-structure-reference"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code",
        "path" : "SubstanceDefinition.code",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "code.coding.system"
            }
          ],
          "rules" : "open"
        },
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:unii",
        "path" : "SubstanceDefinition.code",
        "sliceName" : "unii",
        "short" : "UNII",
        "definition" : "The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substanceâ€™s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/]\nExample: 362O9ITL9D\nNote: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/",
        "min" : 0,
        "max" : "1"
      },
      {
        "id" : "SubstanceDefinition.code:unii.code",
        "path" : "SubstanceDefinition.code.code",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:unii.code.coding",
        "path" : "SubstanceDefinition.code.code.coding",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:unii.code.coding.system",
        "path" : "SubstanceDefinition.code.code.coding.system",
        "min" : 1,
        "patternUri" : "http://fdasis.nlm.nih.gov",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:uniProt",
        "path" : "SubstanceDefinition.code",
        "sliceName" : "uniProt",
        "short" : "UniProt ID",
        "definition" : "The  UniProt ID is an index to the UniProt knowledgebase,  a large resource of protein sequences and associated detailed annotation.\nIt is accessible at https://www.uniprot.org/",
        "min" : 0,
        "max" : "1"
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code",
        "path" : "SubstanceDefinition.code.code",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.coding",
        "path" : "SubstanceDefinition.code.code.coding",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.coding.system",
        "path" : "SubstanceDefinition.code.code.coding.system",
        "min" : 1,
        "patternUri" : "https://www.uniprot.org",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name",
        "path" : "SubstanceDefinition.name",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "type.coding"
            }
          ],
          "description" : "Slice based on value pattern",
          "rules" : "closed"
        },
        "short" : "Substance Name",
        "definition" : "Substance Name is identified by its Substance Type.\nSubstance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined]\nExamples: GSRS Preferred Term, Systematic Name, INN, USP/NF",
        "min" : 1,
        "constraint" : [
          {
            "key" : "cmc-name-preferred",
            "severity" : "error",
            "human" : "Name.preferred: at most one = true",
            "expression" : "select(preferred = true).count() < 2",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "short" : "True when the name type is Substance Name",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:sub",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "sub",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:sub.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "Generic Name",
        "definition" : "A non-branded nor registered name that meant for common use.",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:sub.type",
        "path" : "SubstanceDefinition.name.type",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:sub.type.coding",
        "path" : "SubstanceDefinition.name.type.coding",
        "min" : 1,
        "max" : "1",
        "patternCoding" : {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C97054",
          "display" : "Generic Name"
        },
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:sub.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:gsrs",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "gsrs",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "GSRS Preferred Term",
        "definition" : "Default display name identified within FDA Global Substance Registration System (GSRS).",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type",
        "path" : "SubstanceDefinition.name.type",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type.coding",
        "path" : "SubstanceDefinition.name.type.coding",
        "min" : 1,
        "max" : "1",
        "patternCoding" : {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C203355",
          "display" : "GSRS Preferred Term"
        },
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:isbt",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "isbt",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:isbt.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "ISBT-128 DIN",
        "definition" : "It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type",
        "path" : "SubstanceDefinition.name.type",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type.coding",
        "path" : "SubstanceDefinition.name.type.coding",
        "min" : 1,
        "max" : "1",
        "patternCoding" : {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C95517",
          "display" : "ISBT-128 DIN"
        },
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:isbt.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:comp",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "comp",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:comp.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "Company ID/Code",
        "definition" : "An internal identifier assigned by the sponsor to this drug substance. [Source: SME Defined]",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:comp.type",
        "path" : "SubstanceDefinition.name.type",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:comp.type.coding",
        "path" : "SubstanceDefinition.name.type.coding",
        "min" : 1,
        "max" : "1",
        "patternCoding" : {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C203354",
          "display" : "Company ID/Code"
        }
      }
    ]
  }
}
XIG built as of ??metadata-date??. Found ??metadata-resources?? resources in ??metadata-packages?? packages.