Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

: ffa30c0b-8031-436a-87f1-635b3bbe5989 - JSON Representation

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{
  "resourceType" : "SubstanceDefinition",
  "id" : "ffa30c0b-8031-436a-87f1-635b3bbe5989",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition </b><a name=\"ffa30c0b-8031-436a-87f1-635b3bbe5989\"> </a><a name=\"hcffa30c0b-8031-436a-87f1-635b3bbe5989\"> </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\">ResourceSubstanceDefinition &quot;ffa30c0b-8031-436a-87f1-635b3bbe5989&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity.html\">Drug Substance Impurity</a></p></div><p><b>identifier</b>: hydroxyApatite</p><p><b>classification</b>: Degradation Product <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C176816)</span></p><blockquote><p><b>structure</b></p><p><b>technique</b>: formed from dicalcium phosphate degradation <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>representation</b></p><p><b>type</b>: InChI File (small molecule) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C54683)</span></p><p><b>representation</b>: XZFUZCHOJLQYHV-UHFFFAOYSA-M</p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: SMILES <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C54684)</span></p><p><b>representation</b>: [OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O</p></blockquote></blockquote><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>91D9GV0Z28 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#91D9GV0Z28)</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>TRIBASIC CALCIUM PHOSPHATE</td><td>GSRS Preferred Term <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C203355)</span></td><td>true</td></tr></table></div>"
  },
  "identifier" : [
    {
      "value" : "hydroxyApatite"
    }
  ],
  "classification" : [
    {
      "coding" : [
        {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C176816",
          "display" : "Degradation Product"
        }
      ]
    }
  ],
  "structure" : {
    "technique" : [
      {
        "text" : "formed from dicalcium phosphate degradation"
      }
    ],
    "representation" : [
      {
        "type" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C54683",
              "display" : "InChI File (small molecule)"
            }
          ]
        },
        "representation" : "XZFUZCHOJLQYHV-UHFFFAOYSA-M"
      },
      {
        "type" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C54684",
              "display" : "SMILES"
            }
          ]
        },
        "representation" : "[OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O"
      }
    ]
  },
  "code" : [
    {
      "code" : {
        "coding" : [
          {
            "system" : "http://fdasis.nlm.nih.gov",
            "code" : "91D9GV0Z28"
          }
        ]
      }
    }
  ],
  "name" : [
    {
      "name" : "TRIBASIC CALCIUM PHOSPHATE",
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C203355",
            "display" : "GSRS Preferred Term"
          }
        ]
      },
      "preferred" : true
    }
  ]
}