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
{
"resourceType" : "ObservationDefinition",
"id" : "Degradation",
"meta" : // Contained in Accumulus FHIR Product Example - Stability (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=\"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 "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://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>"
},
"url" : "http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/Degradation",
"title" : "Degradation Products by HPLC (% w/w)",
"status" : "active",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
]
},
"qualifiedValue" : [
{
"appliesTo" : [
{
"text" : "Impurity 1"
}
],
"range" : // could be a code
{
"high" : {
"value" : 0.8,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 2"
}
],
"range" : {
"high" : {
"value" : 0.4,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 3"
}
],
"range" : {
"high" : {
"value" : 0.4,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"appliesTo" : [
{
"text" : "Any Unspecified Degradation Impurity"
}
],
"range" : {
"high" : {
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"appliesTo" : [
{
"text" : "Total Degradation Impurities"
}
],
"range" : {
"high" : {
"value" : 2.3,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
],
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
}
}
]
}
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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