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Resource StructureDefinition/FHIR Server from package hl7.fhir.us.pq-cmc-fda#current (1078 ms)

Package hl7.fhir.us.pq-cmc-fda
Type StructureDefinition
Id Id
FHIR Version R5
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 2.0.0-ballot
Status active
Date 2024-12-12T01:58:44+00:00
Name ImpuritySubstance
Title Drug Substance Impurity
Experimental False
Realm us
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
codeable-concept-text-only Text Only Codeable Concept
literal-reference Literal Reference
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-chemical-structure-datafile-type-terminology Chemical Structure Data File Type Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-impurity-classification-terminology Impurity Classification Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types Representation Types
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type Substance Name Type


Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: StructureDefinition pqcmc-drug-product-substance-impurity

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition C0..*SubstanceDefinitionThe 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
... identifier S0..1Identifieroptional user designated identifier
... classification S1..*CodeableConceptImpurity Classification
Binding: Impurity Classification Terminology (required)
... characterization S0..*BackboneElementGeneral specifications for this substance
.... technique S0..1CodeableConceptTextOnlySubstance Characterisation Technique
.... description S0..1markdownAnalysis Narrative Text and Table
.... Slices for file S0..*AttachmentImpurity Analysis Graphic | Impurity Analytical Instrument Data File
Slice: Unordered, Open by profile:$this
..... file:AnalysisGraphic 0..*GraphicAttachmentAnalysis Graphic
..... file:AnalyticalInstrumentData 0..*AnalyticalInstrumentDataAnalytical Instrument Data File
... structure S0..1BackboneElementStructural information
.... technique S0..*CodeableConceptTextOnlyImpurity Substance Characterisation Technique
.... Slices for representation S0..*BackboneElementImpurity Structure Graphic | Impurity Structure Data File
Slice: Unordered, Closed by value:type
..... representation:All Slices Content/Rules for all slices
...... type S1..1CodeableConceptThe kind of structural representation (e.g. full, partial)
Binding: Representation Types (required)
..... representation:graphic 0..1BackboneElementA graphical, displayable depiction of the structure (e.g. an SVG, PNG)
...... type 0..1CodeableConceptGraphic
Required Pattern: At least the following
....... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
........ system1..1uriIdentity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........ code1..1codeSymbol in syntax defined by the system
Fixed Value: C54273
...... document 1..1LiteralReference(Graphic Reference) {b}Impurity Structure Graphic
..... representation:structureFile 0..*BackboneElementmachine-readable representation -- attached file
...... type 0..1CodeableConceptStructure File
Required Pattern: At least the following
....... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
........ system1..1uriIdentity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........ code1..1codeSymbol in syntax defined by the system
Fixed Value: C103240
...... document S1..1LiteralReference(Structure Data Reference) {b}Impurity Chemical Structure Data (files, e.g. .SDF, .CIF)
..... representation:structureString 0..*BackboneElementmachine-readable representation -- plain text
...... type 0..1CodeableConceptStructure Textual
Required Pattern: At least the following
....... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
........ system1..1uriIdentity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........ code1..1codeSymbol in syntax defined by the system
Fixed Value: C45253
...... representation S1..1stringImpurity Chemical Structure Data (short, plain text representations, e.g. SMILES)
...... format S1..1CodeableConceptDrug Substance Impurity Method Type
Binding: Chemical Structure Data File Type Terminology (required)
... Slices for code S0..*BackboneElementCodes associated with the substance
Slice: Unordered, Open by value:code.coding.system
.... code:unii 0..1BackboneElementUNII
..... code S1..1CodeableConceptThe specific code
...... coding S1..1CodingCode defined by a terminology system
....... system S1..1uriIdentity of the terminology system
Required Pattern: http://fdasis.nlm.nih.gov
.... code:uniProt 0..1BackboneElementUniProt ID
..... code S1..1CodeableConceptThe specific code
...... coding S1..1CodingCode defined by a terminology system
....... system S1..1uriIdentity of the terminology system
Required Pattern: https://www.uniprot.org
... Slices for name SC1..*BackboneElementSubstance Name
Slice: Unordered, Closed by value:type
cmc-name-preferred: Name.preferred: at most one = true
.... name:All Slices Content/Rules for all slices
..... type 0..1CodeableConceptName type e.g. 'systematic', 'scientific, 'brand'
Binding: Substance Name Type (required)
..... preferred S0..1booleanTrue when the name type is Substance Name
.... name:sub S0..1BackboneElementNames applicable to this substance
..... name S1..1stringGeneric Name
..... type S1..1CodeableConceptName type e.g. 'systematic', 'scientific, 'brand'
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: C97054
....... display1..1stringRepresentation defined by the system
Fixed Value: Generic Name
..... preferred S0..1booleanIf this is the preferred name for this substance
.... name:gsrs S0..1BackboneElementNames applicable to this substance
..... name S1..1stringGSRS Preferred Term
..... type S1..1CodeableConceptName type e.g. 'systematic', 'scientific, 'brand'
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: C203355
....... display1..1stringRepresentation defined by the system
Fixed Value: GSRS Preferred Term
..... preferred S0..1booleanIf this is the preferred name for this substance
.... name:isbt S0..1BackboneElementNames applicable to this substance
..... name S1..1stringISBT-128 DIN
..... type S1..1CodeableConceptName type e.g. 'systematic', 'scientific, 'brand'
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: C95517
....... display1..1stringRepresentation defined by the system
Fixed Value: ISBT-128 DIN
..... preferred S0..1booleanIf this is the preferred name for this substance
.... name:comp S0..1BackboneElementNames applicable to this substance
..... name S1..1stringCompany ID/Code
..... type S1..1CodeableConceptName type e.g. 'systematic', 'scientific, 'brand'
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: C203354
....... display1..1stringRepresentation defined by the system
Fixed Value: Company ID/Code

doco 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_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_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_datatype.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\" 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\"><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=\"StructureDefinition-codeable-concept-text-only.html\" title=\"CodeableConcept\">CodeableConceptTextOnly</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; 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: #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_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: #F7F7F7; 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: #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#markdown\">markdown</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; 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: 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_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: white; 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: 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></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=\"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: 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/datatypes.html#Attachment\">Attachment</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\">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: #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_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: #F7F7F7; 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: #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-graphic-attachment.html\" title=\"Attachment\">GraphicAttachment</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; 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: 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_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: white; 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: 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-analytical-intstrument-data.html\" title=\"Attachment\">AnalyticalInstrumentData</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; 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: #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.structure\">structure</a><a name=\"SubstanceDefinition.structure\"> </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/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\">Structural information</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_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_datatype.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\" 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: 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\">*</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=\"StructureDefinition-codeable-concept-text-only.html\" title=\"CodeableConcept\">CodeableConceptTextOnly</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 Substance Characterisation Technique</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</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_bck1033.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_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> representation:All Slices<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\"/><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\">Content/Rules for all slices</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_bck10320.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_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\"/> <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity-definitions.html#SubstanceDefinition.structure.representation.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><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-representation-types.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types\">Representation Types</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: 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.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\">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.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\"><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#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\">Graphic<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: 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_bck103501.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_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#CodeableConcept.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\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">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#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\">Code defined by a terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">(complex)</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_bck1035010.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_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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</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_bck1035000.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_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: 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\">C54273</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=\"StructureDefinition-literal-reference.html\" title=\"Literal Reference\">LiteralReference</a>(<a href=\"StructureDefinition-pqcmc-graphic-reference.html\">Graphic Reference</a>)<a href=\"http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html\"> {</a><a href=\"http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html\" title=\"When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.\">b</a><a href=\"http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html\">}</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_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:structureFile\" title=\"Slice structureFile\">representation:structureFile</a><a name=\"SubstanceDefinition.structure.representation.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\">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 -- attached file<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_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:structureFile.type\">type</a><a name=\"SubstanceDefinition.structure.representation.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\"/><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#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\">Structure File<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: 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_bck103501.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_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#CodeableConcept.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\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">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#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\">Code defined by a terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">(complex)</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_bck1035010.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_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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</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_bck1035000.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_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: 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\">C103240</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:structureFile.document\">document</a><a name=\"SubstanceDefinition.structure.representation.document.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 href=\"StructureDefinition-literal-reference.html\" title=\"Literal Reference\">LiteralReference</a>(<a href=\"StructureDefinition-pqcmc-structure-reference.html\">Structure Data Reference</a>)<a href=\"http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html\"> {</a><a href=\"http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html\" title=\"When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.\">b</a><a href=\"http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html\">}</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 (files, e.g. .SDF, .CIF)</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:structureString\" title=\"Slice structureString\">representation:structureString</a><a name=\"SubstanceDefinition.structure.representation.5\"> </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 -- plain text<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:structureString.type\">type</a><a name=\"SubstanceDefinition.structure.representation.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\"/><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#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\">Structure Textual<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: 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_bck102501.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_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#CodeableConcept.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\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">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#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\">Code defined by a terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">(complex)</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_bck1025010.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_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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</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_bck1025000.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_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: 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\">C45253</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:structureString.representation\" title=\"A machine-readable representation of the structure of the chemical. [Source: SME Defined]\nExamples: SMILES, INCHI\">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\">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\">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_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_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:structureString.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\">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#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<br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-chemical-structure-datafile-type-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology\">Chemical Structure Data File Type 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_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 substance’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</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_bck0330.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_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.type\">type</a><a name=\"SubstanceDefinition.name.type\"> </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\">Name type e.g. 'systematic', 'scientific, 'brand'</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-substance-name-type.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type\">Substance Name Type</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_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: #F7F7F7; 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: #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#boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; 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: 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_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: white; 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: 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\">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\"><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: #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_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: #F7F7F7; 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: #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\">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: #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\">Generic Name</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_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: white; 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.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#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\">Name type e.g. 'systematic', 'scientific, 'brand'</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_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_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#CodeableConcept.coding\">coding</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..*</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#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Code defined by a terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">(complex)</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.system\">system</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#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</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.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\"/><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#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\">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: 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_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: white; 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: 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#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\">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: #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_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: #F7F7F7; 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: #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#boolean\">boolean</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\">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: 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_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: white; 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: 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\">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\"><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: #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_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: #F7F7F7; 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: #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\">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: #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\">GSRS Preferred Term</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_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: white; 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.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..<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\">Name type e.g. 'systematic', 'scientific, 'brand'</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_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_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#CodeableConcept.coding\">coding</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..*</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#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Code defined by a terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">(complex)</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.system\">system</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#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</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.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\"/><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#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\">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: 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_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: white; 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: 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#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\">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: #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_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: #F7F7F7; 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: #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#boolean\">boolean</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\">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: 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_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: white; 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: 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\">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\"><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: #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_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: #F7F7F7; 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: #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\">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: #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\">ISBT-128 DIN</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_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: white; 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.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\">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#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\">Name type e.g. 'systematic', 'scientific, 'brand'</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_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_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#CodeableConcept.coding\">coding</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..*</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#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Code defined by a terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">(complex)</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.system\">system</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#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</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.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\"/><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#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\">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: 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_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: white; 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: 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#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\">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: #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_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: #F7F7F7; 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: #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#boolean\">boolean</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\">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: 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_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: white; 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: 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\">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\"><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: #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_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: #F7F7F7; 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: #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\">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: #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\">Company ID/Code</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_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: white; 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.5\"> </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#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\">Name type e.g. 'systematic', 'scientific, 'brand'</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_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_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#CodeableConcept.coding\">coding</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..*</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#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Code defined by a terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">(complex)</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.system\">system</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#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</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.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\"/><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#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\">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: 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_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: white; 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: 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#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\">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" : "2.0.0-ballot",
  "name" : "ImpuritySubstance",
  "title" : "Drug Substance Impurity",
  "status" : "active",
  "date" : "2024-12-12T01:58:44+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.type.coding.where(\n system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and\n code = 'C103240'\n).exists().not() implies (\n code.where(\n code.coding.exists(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.implicitRules",
        "path" : "SubstanceDefinition.implicitRules",
        "short" : "A set of rules under which this content was created",
        "definition" : "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
        "comment" : "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.implicitRules",
          "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"
          }
        ],
        "mustSupport" : false,
        "isModifier" : true,
        "isModifierReason" : "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation",
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.language",
        "path" : "SubstanceDefinition.language",
        "short" : "Language of the resource content",
        "definition" : "The base language in which the resource is written.",
        "comment" : "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.language",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "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"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : false,
        "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"
            }
          ]
        }
      },
      {
        "id" : "SubstanceDefinition.text",
        "path" : "SubstanceDefinition.text",
        "short" : "Text summary of the resource, for human interpretation",
        "definition" : "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
        "comment" : "Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.",
        "alias" : [
          "narrative",
          "html",
          "xhtml",
          "display"
        ],
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "DomainResource.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Narrative"
          }
        ],
        "condition" : [
          "dom-6"
        ],
        "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" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "Act.text?"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.contained",
        "path" : "SubstanceDefinition.contained",
        "short" : "Contained, inline Resources",
        "definition" : "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.",
        "comment" : "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.",
        "alias" : [
          "inline resources",
          "anonymous resources",
          "contained resources"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "DomainResource.contained",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Resource"
          }
        ],
        "condition" : [
          "dom-2",
          "dom-4",
          "dom-3",
          "dom-5"
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.extension",
        "path" : "SubstanceDefinition.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 resource. 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" : "DomainResource.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"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.modifierExtension",
        "path" : "SubstanceDefinition.modifierExtension",
        "short" : "Extensions that cannot be ignored",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it 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 is allowed to define an extension, there is a set of   "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" : "Substance Characterisation 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.",
        "comment" : "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.characterization.technique",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "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,
        "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" : "rim",
            "map" : "n/a,CD"
          },
          {
            "identity" : "v2",
            "map" : "CE/CNE/CWE"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept rdfs:subClassOf dt:CD"
          }
        ]
      },
      {
        "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.",
        "comment" : "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.structure.technique",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "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,
        "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" : "rim",
            "map" : "n/a,CD"
          },
          {
            "identity" : "v2",
            "map" : "CE/CNE/CWE"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept rdfs:subClassOf dt:CD"
          }
        ]
      },
      {
        "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"
            }
          ],
          "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" : 1,
        "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" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types"
        },
        "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"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Structural_Representation.Structural_Representation_Attachment"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.representation:graphic",
        "path" : "SubstanceDefinition.structure.representation",
        "sliceName" : "graphic",
        "short" : "A graphical, displayable depiction of the structure (e.g. an SVG, PNG)",
        "definition" : "A depiction of the structure of the substance.",
        "min" : 0,
        "max" : "1",
        "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" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Structure.Structural_Representation"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.representation:graphic.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:graphic.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:graphic.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:graphic.type",
        "path" : "SubstanceDefinition.structure.representation.type",
        "short" : "Graphic",
        "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"
          }
        ],
        "patternCodeableConcept" : {
          "coding" : [
            {
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C54273"
            }
          ]
        },
        "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:graphic.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:graphic.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: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,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.structure.representation.document",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"
            ],
            "targetProfile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference"
            ],
            "aggregation" : [
              "bundled"
            ]
          }
        ],
        "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_Attachment"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.representation:structureFile",
        "path" : "SubstanceDefinition.structure.representation",
        "sliceName" : "structureFile",
        "short" : "machine-readable representation -- attached 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" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Structure.Structural_Representation"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.representation:structureFile.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:structureFile.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"
          }
         "id" : "SubstanceDefinition.code:uniProt.extension",
        "path" : "SubstanceDefinition.code.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.code:uniProt.modifierExtension",
        "path" : "SubstanceDefinition.code.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.code:uniProt.code",
        "path" : "SubstanceDefinition.code.code",
        "short" : "The specific code",
        "definition" : "The specific code.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.code.code",
          "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,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Code.Code, Substance_Code.Code_System, Substance_Code.Code_System_Id"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.id",
        "path" : "SubstanceDefinition.code.code.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.code:uniProt.code.extension",
        "path" : "SubstanceDefinition.code.code.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.code:uniProt.code.coding",
        "path" : "SubstanceDefinition.code.code.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"
          }
        ],
        "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.code:uniProt.code.coding.id",
        "path" : "SubstanceDefinition.code.code.coding.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.code:uniProt.code.coding.extension",
        "path" : "SubstanceDefinition.code.code.coding.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.code:uniProt.code.coding.system",
        "path" : "SubstanceDefinition.code.code.coding.system",
        "short" : "Identity of the terminology system",
        "definition" : "The identification of the code system that defines the meaning of the symbol in the code.",
        "comment" : "The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.",
        "requirements" : "Need to be unambiguous about the source of the definition of the symbol.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Coding.system",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "patternUri" : "https://www.uniprot.org",
        "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.3"
          },
          {
            "identity" : "rim",
            "map" : "./codeSystem"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.coding.version",
        "path" : "SubstanceDefinition.code.code.coding.version",
        "short" : "Version of the system - if relevant",
        "definition" : "The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.",
        "comment" : "Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Coding.version",
          "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" : [
&nbs