Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 2.0.0 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

## : 3.2.P.5.5 Bundle - JSON Representation

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    {
      "resourceType" : "Bundle",
      "id" : "CharacterisationImpuritiesProductBundle",
      "meta" : {
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          🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p55"
        ]
      },
      "identifier" : {
        "system" : "urn:ietf:rfc:3986",
        "value" : "urn:uuid:2b738e27-de1f-4f63-8d91-c8860089d2a1"
      },
      "type" : "document",
      "timestamp" : "2024-04-24T01:12:07.108Z",
      "entry" : [
        {
          "fullUrl" : "urn:uuid:8a07e353-9cf6-4f27-8a30-2c2d4f439847",
          "resource" : {
            "resourceType" : "Composition",
            "id" : "8a07e353-9cf6-4f27-8a30-2c2d4f439847",
            "meta" : {
              "profile" : [
                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p55"
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            },
            "text" : {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_8a07e353-9cf6-4f27-8a30-2c2d4f439847\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition 8a07e353-9cf6-4f27-8a30-2c2d4f439847</b></p><a name=\"8a07e353-9cf6-4f27-8a30-2c2d4f439847\"> </a><a name=\"hc8a07e353-9cf6-4f27-8a30-2c2d4f439847\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ectd-composition-32p55.html\">eCTD Product Characterisation of Impurities</a></p></div><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.p.5.5}\">m3.2.p.5.5 characterisation of impurities</span></p><p><b>date</b>: 2024-04-24 01:12:07+0000</p><p><b>author</b>: <a href=\"Bundle-CharacterisationImpuritiesProductBundle.html#urn-uuid-98effc99-db2b-428d-89aa-0ce426e02788\">Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000</a></p><p><b>title</b>: Product Characterisation of Impurities</p></div>"
            },
            "status" : "final",
            "type" : {
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            "date" : "2024-04-24T01:12:07.108Z",
            "author" : [
              {
                "reference" : "urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788"
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            ],
            "title" : "Product Characterisation of Impurities",
            "section" : [
              {
                "title" : "Impurities for TabletCoatedBeadsCoatedAll",
                "code" : {
                  "coding" : [
                    {
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            "resourceType" : "MedicinalProductDefinition",
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            "meta" : {
              "profile" : [
                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities"
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            },
            "text" : {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_ddd3abad-347c-4d2f-95f3-dd804e250502\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition ddd3abad-347c-4d2f-95f3-dd804e250502</b></p><a name=\"ddd3abad-347c-4d2f-95f3-dd804e250502\"> </a><a name=\"hcddd3abad-347c-4d2f-95f3-dd804e250502\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-drug-product-with-impurities.html\">Drug Product Impurities</a></p></div><p><b>identifier</b>: TabletCoatedBeadsCoatedAll</p><p><b>description</b>: </p><div><p>A drug product composed of one type of bead with two coatings inside a coated tablet</p>\n</div><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42964}\">TABLET, MULTILAYER</span></p><p><b>route</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38288}\">ORAL</span></p><h3>Impurities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-CharacterisationImpuritiesProductBundle.html#urn-uuid-58ae52aa-c81e-415a-8791-e67a3195290d\">Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000</a></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-CharacterisationImpuritiesProductBundle.html#urn-uuid-ffa30c0b-8031-436a-87f1-635b3bbe5989\">Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000</a></td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: LEVOTHYROXINE SODIUM ANHYDROUS 125mg</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C96971}\">Non-Proprietary</span></p><blockquote><p><b>part</b></p><p><b>part</b>: LEVOTHYROXINE SODIUM ANHYDROUS</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}\">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 125mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">LEVOTHYROXINE SODIUM ANHYDROUS</span></p></blockquote></blockquote></div>"
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            "identifier" : [
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                "value" : "TabletCoatedBeadsCoatedAll"
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            ],
            "description" : "A drug product composed of one type of bead with two coatings inside a coated tablet",
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            "impurity" : [
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            "name" : [
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                "productName" : "LEVOTHYROXINE SODIUM ANHYDROUS 125mg",
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                  ],
                  "text" : "Non-Proprietary"
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                "part" : [
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                    "part" : "LEVOTHYROXINE SODIUM ANHYDROUS",
                    "type" : {
                      "coding" : [
                        {
                          "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                          "code" : "SCI"
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                      "text" : "LEVOTHYROXINE SODIUM ANHYDROUS"
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                  }
                ]
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788",
          "resource" : {
            "resourceType" : "Organization",
            "id" : "98effc99-db2b-428d-89aa-0ce426e02788",
            "meta" : {
              "profile" : [
                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
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            },
            "text" : {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_98effc99-db2b-428d-89aa-0ce426e02788\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 98effc99-db2b-428d-89aa-0ce426e02788</b></p><a name=\"98effc99-db2b-428d-89aa-0ce426e02788\"> </a><a name=\"hc98effc99-db2b-428d-89aa-0ce426e02788\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: connectathon_Site</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>connectathon_Site, Restful Rd, Danbury, CT, USA</td></tr></table></div>"
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            "identifier" : [
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                "type" : {
                  "coding" : [
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                      "code" : "C134003",
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            "name" : "connectathon_Site",
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                "address" : {
                  "type" : "postal",
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                  "line" : [
                    "Restful Rd"
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                  "city" : "Danbury",
                  "state" : "CT",
                  "postalCode" : "06811",
                  "country" : "USA"
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        },
        {
          "fullUrl" : "urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d",
          "resource" : {
            "resourceType" : "SubstanceDefinition",
            "id" : "58ae52aa-c81e-415a-8791-e67a3195290d",
            "meta" : {
              "profile" : [
                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"
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            "text" : {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_58ae52aa-c81e-415a-8791-e67a3195290d\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 58ae52aa-c81e-415a-8791-e67a3195290d</b></p><a name=\"58ae52aa-c81e-415a-8791-e67a3195290d\"> </a><a name=\"hc58ae52aa-c81e-415a-8791-e67a3195290d\"> </a><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\"/><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>: DCM</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176815}\">Residual Solvent</span></p><blockquote><p><b>structure</b></p><p><b>technique</b>: <span title=\"Codes:\">Leftover Solvent</span></p><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</span></p><p><b>representation</b>: YMWUJEATGCHHMB-UHFFFAOYSA-N</p><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54683}\">InChI File (small molecule)</span></p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</span></p><p><b>representation</b>: ClCCl</p><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54684}\">SMILES</span></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><span title=\"Codes:{http://fdasis.nlm.nih.gov 588X2YUY0A}\">588X2YUY0A</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>DICHLOROMETHANE</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C97054}\">Generic Name</span></td><td>true</td></tr></table></div>"
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            "identifier" : [
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                    "display" : "Residual Solvent"
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            "structure" : {
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                  "text" : "Leftover Solvent"
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              "representation" : [
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                {
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                  "representation" : "ClCCl",
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                    "coding" : [
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                        "code" : "C54684",
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            "code" : [
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                "code" : {
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                      "code" : "588X2YUY0A"
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            "name" : [
              {
                "name" : "DICHLOROMETHANE",
                "type" : {
                  "coding" : [
                    {
                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                      "code" : "C97054",
                      "display" : "Generic Name"
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                "preferred" : true
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        },
        {
          "fullUrl" : "urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989",
          "resource" : {
            "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\"><a name=\"SubstanceDefinition_ffa30c0b-8031-436a-87f1-635b3bbe5989\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition ffa30c0b-8031-436a-87f1-635b3bbe5989</b></p><a name=\"ffa30c0b-8031-436a-87f1-635b3bbe5989\"> </a><a name=\"hcffa30c0b-8031-436a-87f1-635b3bbe5989\"> </a><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\"/><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>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176816}\">Degradation Product</span></p><blockquote><p><b>structure</b></p><p><b>technique</b>: <span title=\"Codes:\">formed from dicalcium phosphate degradation</span></p><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</span></p><p><b>representation</b>: XZFUZCHOJLQYHV-UHFFFAOYSA-M</p><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54683}\">InChI File (small molecule)</span></p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</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><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54684}\">SMILES</span></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><span title=\"Codes:{http://fdasis.nlm.nih.gov 91D9GV0Z28}\">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><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table></div>"
            },
            "identifier" : [
              {
                "value" : "hydroxyApatite"
              }
            ],
            "classification" : [
              {
                "coding" : [
                  {
                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code" : "C176816",
                    "display" : "Degradation Product"
                  }
                ]
              }
            ],
            "structure" : {
              "technique" : [
                {
                  "text" : "formed from dicalcium phosphate degradation"
                }
              ],
              "representation" : [
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                  "representation" : "XZFUZCHOJLQYHV-UHFFFAOYSA-M",
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                {
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                  "representation" : "[OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O",
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            "code" : [
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