This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
@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:ObservationDefinition ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "Degradation"] ; # Contained in Accumulus FHIR Product Example - Stability (05-31-2023)
fhir:meta [
( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq> ] )
] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"Degradation\"> </a><a name=\"hcDegradation\"> </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 ObservationDefinition "Degradation" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ObservationDefinition-test-method-drug-pq.html\">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/Degradation</code></p><p><b>title</b>: Degradation Products by HPLC (% w/w)</p><p><b>status</b>: active</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#DGP)</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.8</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.4</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.4</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Any Unspecified Degradation Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.2</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total Degradation Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-2.3</p></blockquote><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>"
] ; #
fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/Degradation"^^xsd:anyURI] ; #
fhir:title [ fhir:v "Degradation Products by HPLC (% w/w)"] ; #
fhir:status [ fhir:v "active"] ; #
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"^^xsd:anyURI ] ;
fhir:code [ fhir:v "DGP" ] ;
fhir:display [ fhir:v "Degradation Products" ] ] )
] ; #
fhir:qualifiedValue ( [
( fhir:appliesTo [
fhir:text [ fhir:v "Impurity 1" ] # could be a code ] ) ;
fhir:range [
fhir:high [
fhir:value [ fhir:v "0.8"^^xsd:decimal ] ;
fhir:unit [ fhir:v "% w/w" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "%" ] ] ]
] [
( fhir:appliesTo [
fhir:text [ fhir:v "Impurity 2" ] ] ) ;
fhir:range [
fhir:high [
fhir:value [ fhir:v "0.4"^^xsd:decimal ] ;
fhir:unit [ fhir:v "% w/w" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "%" ] ] ]
] [
( fhir:appliesTo [
fhir:text [ fhir:v "Impurity 3" ] ] ) ;
fhir:range [
fhir:high [
fhir:value [ fhir:v "0.4"^^xsd:decimal ] ;
fhir:unit [ fhir:v "% w/w" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "%" ] ] ]
] [
( fhir:appliesTo [
fhir:text [ fhir:v "Any Unspecified Degradation Impurity" ] ] ) ;
fhir:range [
fhir:high [
fhir:value [ fhir:v "0.2"^^xsd:decimal ] ;
fhir:unit [ fhir:v "% w/w" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "%" ] ] ]
] [
( fhir:appliesTo [
fhir:text [ fhir:v "Total Degradation Impurities" ] ] ) ;
fhir:range [
fhir:high [
fhir:value [ fhir:v "2.3"^^xsd:decimal ] ;
fhir:unit [ fhir:v "% w/w" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "%" ] ] ]
] ) ; #
fhir:component ( [
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"^^xsd:anyURI ] ;
fhir:code [ fhir:v "IMP" ] ;
fhir:display [ fhir:v "Impurity" ] ] ) ]
] ) . #
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0. Generated 2024-05-08
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