Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot 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-fda/ and changes regularly. See the Directory of published versions
: 278736ef-2ddf-49e4-895c-3a9f34db36cf - 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 "278736ef-2ddf-49e4-895c-3a9f34db36cf"] ; #
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=\"278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><a name=\"hc278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </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 "278736ef-2ddf-49e4-895c-3a9f34db36cf" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-excipient.html\">Excipient Drug Substance</a></p></div><p><b>identifier</b>: Cochineal</p><p><b>classification</b>: Chemical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48807)</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\">PQ-CMC-FDA Temporary Codes</a>#C134009)</span></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>TZ8Z31B35M <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#TZ8Z31B35M)</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>Cochineal</td><td>GSRS Preferred Term <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</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><td><b>Genus</b></td><td><b>Species</b></td><td><b>CountryOfOrigin</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\">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></td><td>Dactylopius <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>cochineal <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>Turkey <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#TUR)</span></td></tr></table></div>"
] ; #
fhir:identifier ( [
fhir:value [ fhir:v "Cochineal" ]
] ) ; #
fhir:classification ( [
( 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" ] ] )
] ) ; #
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:code ( [
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "TZ8Z31B35M" ] ] ) ]
] ) ; #
fhir:name ( [
fhir:name [ fhir:v "Cochineal" ] ;
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" ] ] ) ] ;
fhir:genus [
fhir:text [ fhir:v "Dactylopius" ] ] ;
fhir:species [
fhir:text [ fhir:v "cochineal" ] ] ;
( fhir:countryOfOrigin [
( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "TUR" ] ;
fhir:display [ fhir:v "Turkey" ] ] ) ] )
] . #