Pharmaceutical Quality (Industry), 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 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions
: Impurities - 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 "Impurities"] ; # Contained in Accumulus FHIR Substance Example - Batch Analysis (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=\"Impurities\"> </a><a name=\"hcImpurities\"> </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 "Impurities" </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/Impurities</code></p><p><b>title</b>: Drug Substance Related Organic impurities</p><p><b>status</b>: active</p><p><b>code</b>: Drug Substance Related Organic impurities <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-s)</span></p><p><b>method</b>: Organic impurities by LC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</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>: ?-0.5</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>: ?-0.5</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>: ?-0.5</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Any individual unspecified impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.10</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-2.0</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/Impurities"^^xsd:anyURI] ; #
fhir:title [ fhir:v "Drug Substance Related Organic impurities"] ; #
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-s" ] ;
fhir:display [ fhir:v "Drug Substance Related Organic impurities" ] ] )
] ; #
fhir:method [
fhir:text [ fhir:v "Organic impurities by LC" ]
] ; #
fhir:qualifiedValue ( [
( fhir:appliesTo [
fhir:text [ fhir:v "Impurity 1" ] ] ) ;
fhir:range [
fhir:high [
fhir:value [ fhir:v "0.5"^^xsd:decimal ] ;
fhir:unit [ fhir:v "% w/w" ] ] ]
] [
( fhir:appliesTo [
fhir:text [ fhir:v "Impurity 2" ] ] ) ;
fhir:range [
fhir:high [
fhir:value [ fhir:v "0.5"^^xsd:decimal ] ;
fhir:unit [ fhir:v "% w/w" ] ] ]
] [
( fhir:appliesTo [
fhir:text [
fhir:v "Impurity 3" ;
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Impurity 3 was included in the release specification throughout clinical development, and no longer forms a part of a commercial release specification; see Section S.4.5 Justification of Specification and Section S.2.5 Validation (PPQ) for additional data" ] # <extension url=\"http:\/\/accumulus.org\/fhir\/extension\/testComment\"> ] ) ] ] ) ;
fhir:range [
fhir:high [
fhir:value [ fhir:v "0.5"^^xsd:decimal ] ;
fhir:unit [ fhir:v "% w/w" ] ] ]
] [
( fhir:appliesTo [
fhir:text [ fhir:v "Any individual unspecified impurity" ] ] ) ;
fhir:range [
fhir:high [
fhir:value [ fhir:v "0.10"^^xsd:decimal ] ;
fhir:unit [ fhir:v "% w/w" ] ] ]
] [
( fhir:appliesTo [
fhir:text [ fhir:v "Total impurities" ] ] ) ;
fhir:range [
fhir:high [
fhir:value [ fhir:v "2.0"^^xsd:decimal ] ;
fhir:unit [ fhir:v "% w/w" ] ] ]
] ) ; #
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" ] ] ) ]
] ) . #
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