FHIR IG analytics| Package | hl7.fhir.uv.pharm-quality |
| Resource Type | ObservationDefinition |
| Id | ObservationDefinition-Impurities.json |
| FHIR Version | R5 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "Impurities"
url: http://example-server.com/fhir/ObservationDefinition/Impurities
title: Drug Substance Related Organic impurities
status: active
code: Drug Substance Related Organic impurities (Example Local Codes - Drug#DGP-s)
method: Organic impurities by LC ()
qualifiedValue
appliesTo: Impurity 1 ()
range: ?-0.5
qualifiedValue
appliesTo: Impurity 2 ()
range: ?-0.5
qualifiedValue
appliesTo: Impurity 3 ()
range: ?-0.5
qualifiedValue
appliesTo: Any individual unspecified impurity ()
range: ?-0.10
qualifiedValue
appliesTo: Total impurities ()
range: ?-2.0
| Code |
| Impurity (Example Local Codes - Drug#IMP) |
{
"resourceType": "ObservationDefinition",
"id": "Impurities",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
]
},
"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
},
"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": {
"high": {
"value": 0.5,
"unit": "% w/w"
}
}
},
{
"appliesTo": [
{
"text": "Any individual unspecified impurity"
}
],
"range": {
"high": {
"value": 0.1,
"unit": "% w/w"
}
}
},
{
"appliesTo": [
{
"text": "Total impurities"
}
],
"range": {
"high": {
"value": 2,
"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"
}
]
}
}
]
}