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FHIR IG analytics

Packagehl7.fhir.uv.pharm-quality
Resource TypeObservationDefinition
IdObservationDefinition-Impurities.json
FHIR VersionR5

Resources that use this resource

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Resources that this resource uses

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "Impurities"

Profile: ObservationDefinition - Test Method PQ

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

Components

-Code
*Impurity (Example Local Codes - Drug#IMP)

Source1

{
  "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"
          }
        ]
      }
    }
  ]
}