{
  "resourceType" : "ValueSet",
  "id" : "pqcmc-impurity-classification-terminology",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet pqcmc-impurity-classification-terminology</b></p><a name=\"pqcmc-impurity-classification-terminology\"> </a><a name=\"hcpqcmc-impurity-classification-terminology\"> </a><ul><li>Include these codes as defined in <a href=\"http://terminology.hl7.org/6.4.0/CodeSystem-v3-nciThesaurus.html\"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C176816</td><td>Degradation Product</td></tr><tr><td>C185190</td><td>Elemental Impurities</td></tr><tr><td>C176815</td><td>Residual Solvent</td></tr><tr><td>C134001</td><td>Inorganic</td></tr><tr><td>C176812</td><td>Process Related/Process</td></tr><tr><td>C185192</td><td>Leachables</td></tr><tr><td>C176813</td><td>Product Related</td></tr><tr><td>C92081</td><td>Microbiological</td></tr></table></li></ul></div>"
  },
  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode" : "brr"
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
    "valueInteger" : 2,
    "_valueInteger" : {
      "extension" : [{
        "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
        "valueCanonical" : "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"
      }]
    }
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
    "valueCode" : "trial-use",
    "_valueCode" : {
      "extension" : [{
        "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
        "valueCanonical" : "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"
      }]
    }
  }],
  "url" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-impurity-classification-terminology",
  "identifier" : [{
    "system" : "urn:ietf:rfc:3986",
    "value" : "urn:oid:2.16.840.1.113883.4.642.40.36.48.36"
  }],
  "version" : "2.0.0",
  "name" : "PqcmcImpurityClassificationTerminology",
  "title" : "Impurity Classification Terminology",
  "status" : "active",
  "experimental" : false,
  "date" : "2025-07-03T13:07:08+00:00",
  "publisher" : "HL7 International / Biomedical Research and Regulation",
  "contact" : [{
    "name" : "HL7 International / Biomedical Research and Regulation",
    "telecom" : [{
      "system" : "url",
      "value" : "http://www.hl7.org/Special/committees/rcrim"
    },
    {
      "system" : "email",
      "value" : "brr@lists.HL7.org"
    }]
  }],
  "description" : "Terminology used to qualify the information pertaining to impurity classifications in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.",
  "jurisdiction" : [{
    "coding" : [{
      "system" : "urn:iso:std:iso:3166",
      "code" : "US",
      "display" : "United States of America"
    }]
  }],
  "compose" : {
    "include" : [{
      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
      "concept" : [{
        "code" : "C176816",
        "display" : "Degradation Product"
      },
      {
        "code" : "C185190",
        "display" : "Elemental Impurities"
      },
      {
        "code" : "C176815",
        "display" : "Residual Solvent"
      },
      {
        "code" : "C134001",
        "display" : "Inorganic"
      },
      {
        "code" : "C176812",
        "display" : "Process Related/Process"
      },
      {
        "code" : "C185192",
        "display" : "Leachables"
      },
      {
        "code" : "C176813",
        "display" : "Product Related"
      },
      {
        "code" : "C92081",
        "display" : "Microbiological"
      }]
    }]
  }
}