Pharmaceutical Quality (Industry)
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This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

: Degradation - 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: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></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 &quot;Degradation&quot; </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://hl7.org/fhir/uv/pharm-quality/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.html\">CodeSystem - 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.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>"
  ] ; # 
  fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/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"^^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"^^xsd:anyURI ] ;
fhir:code [ fhir:v "IMP" ] ;
fhir:display [ fhir:v "Impurity" ]       ] )     ]
  ] ) . #