Pharmaceutical Quality (Industry)
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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

: Impurities - JSON Representation

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{
  "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></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 &quot;Impurities&quot; </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/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.html\">CodeSystem - 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.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>"
  },
  "url" : "http://hl7.org/fhir/uv/pharm-quality/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",
        "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",
            "code" : "IMP",
            "display" : "Impurity"
          }
        ]
      }
    }
  ]
}