FHIR IG analytics| Package | hl7.fhir.us.pq-cmc-fda |
| Resource Type | Bundle |
| Id | Bundle-ControlMaterialsBundle.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
"resourceType": "Bundle",
"id": "ControlMaterialsBundle",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s23"
]
},
"identifier": {
"system": "urn:ietf:rfc:3986",
"value": "urn:uuid:7ce2088d-d281-4e2f-9a25-120a1f9805d1"
},
"type": "document",
"timestamp": "2023-12-05T01:34:39.503Z",
"entry": [
{
"fullUrl": "urn:uuid:5c0d341e-6e4f-457c-811d-cfaf3eb62ecd",
"resource": {
"resourceType": "Composition",
"id": "5c0d341e-6e4f-457c-811d-cfaf3eb62ecd",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_5c0d341e-6e4f-457c-811d-cfaf3eb62ecd\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition 5c0d341e-6e4f-457c-811d-cfaf3eb62ecd</b></p><a name=\"5c0d341e-6e4f-457c-811d-cfaf3eb62ecd\"> </a><a name=\"hc5c0d341e-6e4f-457c-811d-cfaf3eb62ecd\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ectd-composition-32s23.html\">eCTD Substance Control of Materials</a></p></div><p><b>identifier</b>: materials1</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.s.2.3}\">m3.2.s.2.3 control of materials</span></p><p><b>date</b>: 2023-12-05 01:34:39+0000</p><p><b>author</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-49438799-e286-432c-b8d8-68ac77e7f519\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><p><b>title</b>: Control of Materials Example</p></div>"
},
"identifier": [
{
"value": "materials1"
}
],
"status": "final",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/ICHContextOfUse",
"code": "ich_3.2.s.2.3",
"display": "m3.2.s.2.3 control of materials"
}
]
},
"subject": [
{
"reference": "urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a"
}
],
"date": "2023-12-05T01:34:39.502Z",
"author": [
{
"reference": "urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519"
}
],
"title": "Control of Materials Example",
"section": [
{
"code": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/ICHContextOfUse",
"code": "ich_3.2.s.3.1",
"display": "m3.2.s.3.1 elucidation of structure and other characteristics"
}
]
},
"entry": [
{
"reference": "urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e"
}
]
},
{
"code": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/ICHContextOfUse",
"code": "ich_3.2.s.3.1",
"display": "m3.2.s.3.1 elucidation of structure and other characteristics"
}
]
},
"entry": [
{
"reference": "urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b"
}
]
},
{
"code": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/ICHContextOfUse",
"code": "ich_3.2.s.3.1",
"display": "m3.2.s.3.1 elucidation of structure and other characteristics"
}
]
},
"entry": [
{
"reference": "urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89"
}
]
}
]
}
},
{
"fullUrl": "urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "cd84a8b5-4e96-551c-15c6-c97c943eb38a",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_cd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition cd84a8b5-4e96-551c-15c6-c97c943eb38a</b></p><a name=\"cd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </a><a name=\"hccd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-routine-drug-substance.html\">Drug Substance Handle</a></p></div><p><b>identifier</b>: salicylate</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}\">USP-NF</span></p><p><b>manufacturer</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov R16CO5Y76E}\">R16CO5Y76E</span></td></tr></table><blockquote><p><b>name</b></p><p><b>name</b>: ACETYLSALICYLIC ACID</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C97054}\">Generic Name</span></p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: ASPIRIN</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></p><p><b>preferred</b>: true</p></blockquote></div>"
},
"identifier": [
{
"value": "salicylate"
}
],
"classification": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C48807",
"display": "Chemical"
}
]
}
],
"grade": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134006",
"display": "USP-NF"
}
]
}
],
"manufacturer": [
{
"reference": "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"
}
],
"code": [
{
"code": {
"coding": [
{
"system": "http://fdasis.nlm.nih.gov",
"code": "R16CO5Y76E"
}
]
}
}
],
"name": [
{
"name": "ACETYLSALICYLIC ACID",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C97054",
"display": "Generic Name"
}
]
}
},
{
"name": "ASPIRIN",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203355",
"display": "GSRS Preferred Term"
}
]
},
"preferred": true
}
]
}
},
{
"fullUrl": "urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579",
"resource": {
"resourceType": "Organization",
"id": "4b565cf3-5353-48af-8cd6-5ccf4e9fd579",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_4b565cf3-5353-48af-8cd6-5ccf4e9fd579\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579</b></p><a name=\"4b565cf3-5353-48af-8cd6-5ccf4e9fd579\"> </a><a name=\"hc4b565cf3-5353-48af-8cd6-5ccf4e9fd579\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/783452221, FEI/6913973</p><p><b>name</b>: Manufacturing Site (J. Jones Research)</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States</td></tr></table></div>"
},
"identifier": [
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134003",
"display": "DUNS"
}
]
},
"system": "urn:oid:1.3.6.1.4.1.519.1",
"value": "783452221"
},
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134004",
"display": "FEI"
}
]
},
"system": "urn:oid:2.16.840.1.113883.4.82",
"value": "6913973"
}
],
"name": "Manufacturing Site (J. Jones Research)",
"contact": [
{
"address": {
"type": "postal",
"text": "Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States",
"line": [
"444 Grant Street"
],
"city": "Bedford",
"state": "NY",
"postalCode": "15600",
"country": "USA"
}
}
]
}
},
{
"fullUrl": "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5",
"resource": {
"resourceType": "Organization",
"id": "e99bddfa-c1b5-435b-bbe8-24816b4e23e5",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization e99bddfa-c1b5-435b-bbe8-24816b4e23e5</b></p><a name=\"e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><a name=\"hce99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/143265222, FEI/6981397</p><p><b>name</b>: Vidinaid</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA</td></tr></table></div>"
},
"identifier": [
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134003",
"display": "DUNS"
}
]
},
"system": "urn:oid:1.3.6.1.4.1.519.1",
"value": "143265222"
},
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134004",
"display": "FEI"
}
]
},
"system": "urn:oid:2.16.840.1.113883.4.82",
"value": "6981397"
}
],
"name": "Vidinaid",
"contact": [
{
"address": {
"type": "postal",
"text": "Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA",
"line": [
"100 Stillwater Avenue",
"Building #2"
],
"city": "Bangor",
"state": "ME",
"postalCode": "04401",
"country": "USA"
}
}
]
}
},
{
"fullUrl": "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049",
"resource": {
"resourceType": "Organization",
"id": "d9e7c2f7-0f59-4645-bb6d-5a8dd2425049",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</b></p><a name=\"d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><a name=\"hcd9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/173265332</p><p><b>name</b>: Mega Chem Supply</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Mega Chem Supply, 350 W Main Street, Rochester, NY, United States</td></tr></table></div>"
},
"identifier": [
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134003",
"display": "DUNS"
}
]
},
"system": "urn:oid:1.3.6.1.4.1.519.1",
"value": "173265332"
}
],
"name": "Mega Chem Supply",
"contact": [
{
"address": {
"type": "postal",
"text": "Mega Chem Supply, 350 W Main Street, Rochester, NY, United States",
"line": [
"350 W Main Street"
],
"city": "Rochester",
"state": "NY",
"postalCode": "14608",
"country": "USA"
}
}
]
}
},
{
"fullUrl": "urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "0efb1188-04f0-44ba-bfe7-ca6169ca8703",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_0efb1188-04f0-44ba-bfe7-ca6169ca8703\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 0efb1188-04f0-44ba-bfe7-ca6169ca8703</b></p><a name=\"0efb1188-04f0-44ba-bfe7-ca6169ca8703\"> </a><a name=\"hc0efb1188-04f0-44ba-bfe7-ca6169ca8703\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-excipient.html\">Excipient Drug Substance</a></p></div><p><b>identifier</b>: carrageenan</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C103206}\">Structurally Diverse Substance</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134009}\">Company Standard</span></p><p><b>manufacturer</b>: <a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-4b565cf3-5353-48af-8cd6-5ccf4e9fd579\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov 5C69YCD2YJ}\">5C69YCD2YJ</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>Carrageenan</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Genus</b></td><td><b>Species</b></td><td><b>Part</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C14258}\">Plant</span></td><td><span title=\"Codes:\">palmaria</span></td><td><span title=\"Codes:\">palmata</span></td><td><span title=\"Codes:\">whole</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 USA}\">United States of America</span></td></tr></table></div>"
},
"identifier": [
{
"value": "carrageenan"
}
],
"classification": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C103206",
"display": "Structurally Diverse Substance"
}
]
}
],
"grade": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134009",
"display": "Company Standard"
}
]
}
],
"manufacturer": [
{
"reference": "urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579"
}
],
"code": [
{
"code": {
"coding": [
{
"system": "http://fdasis.nlm.nih.gov",
"code": "5C69YCD2YJ"
}
]
}
}
],
"name": [
{
"name": "Carrageenan",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203355",
"display": "GSRS Preferred Term"
}
]
},
"preferred": true
}
],
"sourceMaterial": {
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C14258",
"display": "Plant"
}
]
},
"genus": {
"text": "palmaria"
},
"species": {
"text": "palmata"
},
"part": {
"text": "whole"
},
"countryOfOrigin": [
{
"coding": [
{
"system": "urn:iso:std:iso:3166",
"code": "USA",
"display": "United States of America"
}
]
}
]
}
}
},
{
"fullUrl": "urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "fd84a8b5-9e96-451c-a5c6-097c943eb38a",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_fd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition fd84a8b5-9e96-451c-a5c6-097c943eb38a</b></p><a name=\"fd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </a><a name=\"hcfd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-excipient.html\">Excipient Drug Substance</a></p></div><p><b>identifier</b>: Citric acid</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134009}\">Company Standard</span></p><p><b>manufacturer</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov XF417D3PSL}\">XF417D3PSL</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>ANHYDROUS CITRIC ACID</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></td></tr></table></div>"
},
"identifier": [
{
"value": "Citric acid"
}
],
"classification": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C48807",
"display": "Chemical"
}
]
}
],
"grade": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134009",
"display": "Company Standard"
}
]
}
],
"manufacturer": [
{
"reference": "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"
}
],
"supplier": [
{
"reference": "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"
}
],
"code": [
{
"code": {
"coding": [
{
"system": "http://fdasis.nlm.nih.gov",
"code": "XF417D3PSL"
}
]
}
}
],
"name": [
{
"name": "ANHYDROUS CITRIC ACID",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203355",
"display": "GSRS Preferred Term"
}
]
},
"preferred": true
}
],
"sourceMaterial": {
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C48807",
"display": "Chemical"
}
]
}
}
}
},
{
"fullUrl": "urn:uuid:d3a11b25-e160-4688-b807-6383364096fd",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "d3a11b25-e160-4688-b807-6383364096fd",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_d3a11b25-e160-4688-b807-6383364096fd\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition d3a11b25-e160-4688-b807-6383364096fd</b></p><a name=\"d3a11b25-e160-4688-b807-6383364096fd\"> </a><a name=\"hcd3a11b25-e160-4688-b807-6383364096fd\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-excipient.html\">Excipient Drug Substance</a></p></div><p><b>identifier</b>: water</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176793}\">BP</span></p><p><b>manufacturer</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov 059QF0KO0R}\">059QF0KO0R</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>WATER</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></td></tr></table></div>"
},
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{
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"classification": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C48807",
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}
]
}
],
"grade": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C176793",
"display": "BP"
}
]
}
],
"manufacturer": [
{
"reference": "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"
}
],
"supplier": [
{
"reference": "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"
}
],
"code": [
{
"code": {
"coding": [
{
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}
]
}
}
],
"name": [
{
"name": "WATER",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203355",
"display": "GSRS Preferred Term"
}
]
},
"preferred": true
}
],
"sourceMaterial": {
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C48807",
"display": "Chemical"
}
]
}
}
}
},
{
"fullUrl": "urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e",
"resource": {
"resourceType": "PlanDefinition",
"id": "ab241f8c-d21e-4382-a70a-52190dbdf07e",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"
]
},
"text": {
"status": "extensions",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_ab241f8c-d21e-4382-a70a-52190dbdf07e\"> </a>\n<div>\n <table class=\"grid dict\">\n \n <tr>\n <th scope=\"row\"><b>Id: </b></th>\n <td style=\"padding-left: 4px;\">ab241f8c-d21e-4382-a70a-52190dbdf07e</td>\n </tr>\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Version: </b></th>\n <td style=\"padding-left: 4px;\">1.0</td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\">\n <b>\n \n \n \n </b>\n </th>\n <td style=\"padding-left: 4px;\">\n \n <p style=\"margin-bottom: 5px;\">\n <span>RawCitricacid</span>\n </p>\n \n </td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Title: </b></th>\n <td style=\"padding-left: 4px;\">Raw Material (Carrageenan) Specification Example</td>\n </tr>\n \n\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Type: </b></th>\n <td style=\"padding-left: 4px;\">\n \n \n \n <p style=\"margin-bottom: 5px;\">\n <b>system: </b> <span><a href=\"http://terminology.hl7.org/6.4.0/CodeSystem-plan-definition-type.html\">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>code: </b> <span>workflow-definition</span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>display: </b> <span>Workflow Definition</span>\n </p>\n \n \n \n <p style=\"margin-bottom: 5px;\">\n <b>system: </b> <span><a href=\"https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>code: </b> <span>C133931</span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>display: </b> <span>Raw Materials/Excipients/Intermediates/Reagents</span>\n </p>\n \n \n \n \n </td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Subject: </b></th>\n \n \n <td style=\"padding-left: 4px;\">\n \n <p style=\"margin-bottom: 5px;\">\n <b>reference: </b> <span>urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703</span>\n </p>\n \n \n \n </td>\n \n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Date: </b></th>\n <td style=\"padding-left: 4px;\">2023-11-28</td>\n </tr>\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Actions: </b></th>\n <td style=\"padding-left: 4px;\">\n <table class=\"grid-dict\">\n \n <tr>\n <td>\n \n <b>Single Stage Identification:</b> \n \n <br/>\n \n \n \n <b>Then:</b>\n <table class=\"grid-dict\">\n \n <tr>\n <td>\n \n <b> Identification A:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Identification B:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Identification C:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Identification D:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n </table>\n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Microbial Limits:</b> \n \n <br/>\n \n \n \n <b>Then:</b>\n <table class=\"grid-dict\">\n \n <tr>\n <td>\n \n <b> Total Bacterial Count:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Salmonella:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Escherichia Coli:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n </table>\n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Elemental Impurities:</b> \n \n <br/>\n \n \n \n <b>Then:</b>\n <table class=\"grid-dict\">\n \n <tr>\n <td>\n \n <b> Cadmium (Cd):</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Mercury (Hg):</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Arsenic (As):</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Lead (Pb):</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n </table>\n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Residual Solvents:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Impurity: Insoluble Matter:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Solubility in H2O:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n </table>\n </td>\n </tr>\n \n </table>\n</div>\n</div>"
},
"extension": [
{
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{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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}
]
}
}
],
"identifier": [
{
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],
"version": "1.0",
"title": "Raw Material (Carrageenan) Specification Example",
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{
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{
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{
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},
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{
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{
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},
{
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{
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}
]
}
],
"target": [
{
"detailString": "Viscous upon cooling"
}
]
},
{
"id": "2c6e465b-4dec-4a09-9dc5-58c480009d27",
"description": {
"text": "Kappa, iota or lambda"
},
"addresses": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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]
},
{
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{
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}
]
}
],
"target": [
{
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}
]
},
{
"id": "c233a5f7-37e2-4b2b-9f04-cf1b25534865",
"description": {
"text": "Blue, stringy precipitate forms"
},
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{
"coding": [
{
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{
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}
]
}
],
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{
"detailString": "Blue stringy precipitate forms"
}
]
},
{
"id": "c759888d-1eac-4a12-aa9b-403f395f2c18",
"description": {
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},
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{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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}
]
},
{
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{
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}
]
}
],
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{
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}
]
},
{
"id": "66d4035c-633a-49b1-b974-e3171911f44a",
"description": {
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{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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},
{
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}
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}
],
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{
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"unit": "colony forming unit",
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}
]
},
{
"id": "95bf9d43-f337-4905-9c50-788b69d00843",
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{
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{
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},
{
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{
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}
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}
]
},
{
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{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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},
{
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}
]
}
],
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}
]
},
{
"id": "af4ec6c3-4590-43f7-92e0-c8dae0e76e1f",
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"text": "As Reported"
},
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{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134029",
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}
]
},
{
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{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134030",
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}
]
}
],
"target": [
{
"detailString": "As Reported"
}
]
},
{
"id": "b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73",
"description": {
"text": "As Reported"
},
"addresses": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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}
]
},
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134030",
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}
]
}
],
"target": [
{
"detailString": "As Reported"
}
]
},
{
"id": "464f3063-0a4b-4408-9f4a-d6c0b8170097",
"description": {
"text": "<= 3 ppm"
},
"addresses": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134029",
"display": "Release"
}
]
},
{
"coding": [
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"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_5819b223-d3d2-419f-b617-b3a9a3625b89\"> </a>\n<div>\n <table class=\"grid dict\">\n \n <tr>\n <th scope=\"row\"><b>Id: </b></th>\n <td style=\"padding-left: 4px;\">5819b223-d3d2-419f-b617-b3a9a3625b89</td>\n </tr>\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Version: </b></th>\n <td style=\"padding-left: 4px;\">1.0</td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\">\n <b>\n \n \n \n </b>\n </th>\n <td style=\"padding-left: 4px;\">\n \n <p style=\"margin-bottom: 5px;\">\n <span>WaterSpecification</span>\n </p>\n \n </td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Title: </b></th>\n <td style=\"padding-left: 4px;\">Water Specification Example</td>\n </tr>\n \n\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Type: </b></th>\n <td style=\"padding-left: 4px;\">\n \n \n \n <p style=\"margin-bottom: 5px;\">\n <b>system: </b> <span><a href=\"http://terminology.hl7.org/6.4.0/CodeSystem-plan-definition-type.html\">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>code: </b> <span>workflow-definition</span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>display: </b> <span>Workflow Definition</span>\n </p>\n \n \n \n <p style=\"margin-bottom: 5px;\">\n <b>system: </b> <span><a href=\"https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>code: </b> <span>C133931</span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>display: </b> <span>Raw Materials/Excipients/Intermediates/Reagents</span>\n </p>\n \n \n \n \n </td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Subject: </b></th>\n \n \n <td style=\"padding-left: 4px;\">\n \n <p style=\"margin-bottom: 5px;\">\n <b>reference: </b> <span>urn:uuid:d3a11b25-e160-4688-b807-6383364096fd</span>\n </p>\n \n \n \n </td>\n \n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Date: </b></th>\n <td style=\"padding-left: 4px;\">2023-12-01</td>\n </tr>\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Actions: </b></th>\n <td style=\"padding-left: 4px;\">\n <table class=\"grid-dict\">\n \n <tr>\n <td>\n \n <b>Single Stage Color degree:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Turbidity:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Smell and taste:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Total hardness:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n </table>\n </td>\n </tr>\n \n </table>\n</div>\n</div>"
},
"extension": [
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],
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],
"version": "1.0",
"title": "Water Specification Example",
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"code": "workflow-definition",
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{
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"goal": [
{
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{
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{
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{
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"text": "Spectrophotometer"
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{
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"code": "C139027",
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{
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"text": "Titration"
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"code": "C134264",
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}
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},
{
"fullUrl": "urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519",
"resource": {
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"id": "49438799-e286-432c-b8d8-68ac77e7f519",
"meta": {
"profile": [
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]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_49438799-e286-432c-b8d8-68ac77e7f519\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 49438799-e286-432c-b8d8-68ac77e7f519</b></p><a name=\"49438799-e286-432c-b8d8-68ac77e7f519\"> </a><a name=\"hc49438799-e286-432c-b8d8-68ac77e7f519\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/143265625</p><p><b>name</b>: J. Jones Research</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>J. Jones Research, 123 Broad Way, New York, NY, United States</td></tr></table></div>"
},
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{
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},
"system": "urn:oid:1.3.6.1.4.1.519.1",
"value": "143265625"
}
],
"name": "J. Jones Research",
"contact": [
{
"address": {
"type": "postal",
"text": "J. Jones Research, 123 Broad Way, New York, NY, United States",
"line": [
"123 Broad Way"
],
"city": "New York",
"state": "NY",
"postalCode": "00062",
"country": "USA"
}
}
]
}
}
]
}