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FHIR IG Statistics: ValueSet/pqcmc-impurity-classification-terminology

Packagehl7.fhir.us.pq-cmc-fda
TypeValueSet
Idpqcmc-impurity-classification-terminology
FHIR VersionR5
Sourcehttp://hl7.org/fhir/us/pq-cmc-fda/https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda/ValueSet-pqcmc-impurity-classification-terminology.html
URLhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-impurity-classification-terminology
Version2.0.0
Statusactive
Date2025-07-03T13:07:08+00:00
NamePqcmcImpurityClassificationTerminology
TitleImpurity Classification Terminology
Realmus
Authorityhl7
DescriptionTerminology used to qualify the information pertaining to impurity classifications in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Resources that use this resource

StructureDefinition
pqcmc-drug-product-substance-impurityDrug Substance Impurity

Resources that this resource uses

CodeSystem
Thesaurus.owlNCI Thesaurus
Thesaurus.owlNCI Thesaurus

Narrative

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

Generated Narrative: ValueSet pqcmc-impurity-classification-terminology

  • Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    CodeDisplay
    C176816Degradation Product
    C185190Elemental Impurities
    C176815Residual Solvent
    C134001Inorganic
    C176812Process Related/Process
    C185192Leachables
    C176813Product Related
    C92081Microbiological

Source

{
  "resourceType": "ValueSet",
  "id": "pqcmc-impurity-classification-terminology",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "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"
          }
        ]
      }
    ]
  }
}