Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
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Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc/ and changes regularly. See the Directory of published versions

: Example SubstanceDefinition for anhydrous citric acid - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:SubstanceDefinition ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "fd84a8b5-9e96-451c-a5c6-097c943eb38a"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"fd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </a></p><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\">Resource SubstanceDefinition &quot;fd84a8b5-9e96-451c-a5c6-097c943eb38a&quot; </p><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>: Chemical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ema-dummy.html\">Dummy EMA Codesystem</a>#1)</span></p><p><b>grade</b>: Company Standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C134009)</span></p><p><b>manufacturer</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5</a></p><p><b>supplier</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</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>XF417D3PSL <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (gsrs.ncats.nih.gov#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>GSRS Preferred Term <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C203355)</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>Chemical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C48807)</span></td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:value [ fhir:v "Citric acid" ]
  ] ) ; # 
  fhir:classification ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ema-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "1" ] ;
fhir:display [ fhir:v "Chemical" ]     ] )
  ] ) ; # 
  fhir:grade ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134009" ] ;
fhir:display [ fhir:v "Company Standard" ]     ] )
  ] ) ; # 
  fhir:manufacturer ( [
fhir:reference [ fhir:v "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5" ]
  ] ) ; # 
  fhir:supplier ( [
fhir:reference [ fhir:v "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049" ]
  ] ) ; # 
  fhir:code ( [
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "XF417D3PSL" ]       ] )     ]
  ] ) ; # 
  fhir:name ( [
fhir:name [ fhir:v "ANHYDROUS CITRIC ACID" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C203355" ] ;
fhir:display [ fhir:v "GSRS Preferred Term" ]       ] )     ] ;
fhir:preferred [ fhir:v "true"^^xsd:boolean ]
  ] ) ; # 
  fhir:sourceMaterial [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48807" ] ;
fhir:display [ fhir:v "Chemical" ]       ] )     ]
  ] . #