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
: DrugProductComponent example for an excipient - Maize starch - 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:Ingredient ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "d01421cc-6488-468b-a676-d3e7281875e2"] ; #
fhir:meta [
( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component> ] )
] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"d01421cc-6488-468b-a676-d3e7281875e2\"> </a><a name=\"hcd01421cc-6488-468b-a676-d3e7281875e2\"> </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 Ingredient "d01421cc-6488-468b-a676-d3e7281875e2" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-component.html\">Drug Product Component</a></p></div><p><b>status</b>: draft</p><p><b>role</b>: Inactive Ingredient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C42637)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-bd0f0a7a-27ea-4884-801d-bd0546e80888.html#urn-uuid-393a14e7-3edc-4373-bbe5-9e569d504a1c\">urn:uuid:393a14e7-3edc-4373-bbe5-9e569d504a1c</a></td></tr></table><h3>Strengths</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>Presentation[x]</b></td><td><b>TextPresentation</b></td></tr><tr><td style=\"display: none\">*</td><td/><td>700 mg<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')</span>/1 [arb'U]<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C75765 = '[arb'U]')</span></td><td>700mg</td></tr></table></blockquote></div>"
] ; #
fhir:status [ fhir:v "draft"] ; #
fhir:role [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C42637" ] ;
fhir:display [ fhir:v "Inactive Ingredient" ] ] )
] ; #
fhir:substance [
fhir:code [
fhir:reference [
fhir:reference [ fhir:v "urn:uuid:393a14e7-3edc-4373-bbe5-9e569d504a1c" ] ] ] ;
( fhir:strength [
( fhir:extension [
( fhir:extension [
fhir:url [ fhir:v "strengthType"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C168628" ] ;
fhir:display [ fhir:v "Mass" ] ] ) ] ] [
fhir:url [ fhir:v "contentPercent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "0.5828"^^xsd:decimal ] ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension"^^xsd:anyURI ] ] ) ;
fhir:presentation [
a fhir:Ratio ;
fhir:numerator [
fhir:value [ fhir:v "700"^^xsd:decimal ] ;
fhir:unit [ fhir:v "mg" ] ;
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C28253" ] ] ;
fhir:denominator [
fhir:value [ fhir:v "1"^^xsd:decimal ] ;
fhir:unit [ fhir:v "[arb'U]" ] ;
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C75765" ] ] ] ;
fhir:textPresentation [ fhir:v "700mg" ] ] )
] . #