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
{
"resourceType" : "ObservationDefinition",
"id" : "Impurities",
"meta" : // Contained in Accumulus FHIR Substance Example - Batch Analysis (05-31-2023)
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
]
},
"text" : {
"status" : "generated",
"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>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/Impurities",
"title" : "Drug Substance Related Organic impurities",
"status" : "active",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
"code" : "DGP-s",
"display" : "Drug Substance Related Organic impurities"
}
]
},
"method" : {
"text" : "Organic impurities by LC"
},
"qualifiedValue" : [
{
"appliesTo" : [
{
"text" : "Impurity 1"
}
],
"range" : {
"high" : {
"value" : 0.5,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 2"
}
],
"range" : {
"high" : {
"value" : 0.5,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 3",
"_text" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq",
"valueString" : "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"
}
]
}
}
],
"range" : // <extension url="http://accumulus.org/fhir/extension/testComment">
{
"high" : {
"value" : 0.5,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Any individual unspecified impurity"
}
],
"range" : {
"high" : {
"value" : 0.10,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Total impurities"
}
],
"range" : {
"high" : {
"value" : 2.0,
"unit" : "% w/w"
}
}
}
],
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
"code" : "IMP",
"display" : "Impurity"
}
]
}
}
]
}