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 - XML Representation

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    <Bundle xmlns="http://hl7.org/fhir">
      <id value="CharacterisationImpuritiesProductBundle"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p55"/>
      </meta>
      <identifier>
        <system value="urn:ietf:rfc:3986"/>
        <value value="urn:uuid:2b738e27-de1f-4f63-8d91-c8860089d2a1"/>
      </identifier>
      <type value="document"/>
      <timestamp value="2024-04-24T01:12:07.108Z"/>
      <entry>
        <fullUrl value="urn:uuid:8a07e353-9cf6-4f27-8a30-2c2d4f439847"/>
        <resource>
          <Composition>
            <id value="8a07e353-9cf6-4f27-8a30-2c2d4f439847"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p55"/>
            </meta>
            <text>
              <status value="generated"/>
              <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>
            </text>
            <status value="final"/>
            <type>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/ICHContextOfUse"/>
                <code value="ich_3.2.p.5.5"/>
                <display value="m3.2.p.5.5 characterisation of impurities"/>
              </coding>
            </type>
            <date value="2024-04-24T01:12:07.108Z"/>
            <author>
              <reference value="urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788"/>
            </author>
            <title value="Product Characterisation of Impurities"/>
            <section>
              <title value="Impurities for TabletCoatedBeadsCoatedAll"/>
              <code>
                <coding>
                  <system
                          value="http://terminology.hl7.org/CodeSystem/ICHContextOfUse"/>
                  <code value="ich_3.2.p.5.5"/>
                  <display value="m3.2.p.5.5 characterisation of impurities"/>
                </coding>
              </code>
              <entry>
                <reference value="urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502"/>
              </entry>
            </section>
          </Composition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502"/>
        <resource>
          <MedicinalProductDefinition>
            <id value="ddd3abad-347c-4d2f-95f3-dd804e250502"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities"/>
            </meta>
            <text>
              <status value="generated"/>
              <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>
    </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>
            </text>
            <identifier>
              <value value="TabletCoatedBeadsCoatedAll"/>
            </identifier>
            <description
                         value="A drug product composed of one type of bead with two coatings inside a coated tablet"/>
            <combinedPharmaceuticalDoseForm>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C42964"/>
                <display value="TABLET, MULTILAYER"/>
              </coding>
            </combinedPharmaceuticalDoseForm>
            <route>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C38288"/>
                <display value="ORAL"/>
              </coding>
            </route>
            <impurity>
              <reference>
                <reference value="urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d"/>
              </reference>
            </impurity>
            <impurity>
              <reference>
                <reference value="urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989"/>
              </reference>
            </impurity>
            <name>
              <productName value="LEVOTHYROXINE SODIUM ANHYDROUS 125mg"/>
              <type>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C96971"/>
                  <display value="Nonproprietary Name"/>
                </coding>
                <text value="Non-Proprietary"/>
              </type>
              <part>
                <part value="LEVOTHYROXINE SODIUM ANHYDROUS"/>
                <type>
                  <coding>
                    <system
                            value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
                    <code value="SCI"/>
                  </coding>
                </type>
              </part>
              <part>
                <part value="125mg"/>
                <type>
                  <coding>
                    <system
                            value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
                    <code value="STR"/>
                  </coding>
                  <text value="LEVOTHYROXINE SODIUM ANHYDROUS"/>
                </type>
              </part>
            </name>
          </MedicinalProductDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788"/>
        <resource>
          <Organization>
            <id value="98effc99-db2b-428d-89aa-0ce426e02788"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
            </meta>
            <text>
              <status value="generated"/>
              <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>
            </text>
            <identifier>
              <type>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134003"/>
                  <display value="DUNS"/>
                </coding>
              </type>
              <system value="urn:oid:1.3.6.1.4.1.519.1"/>
              <value value="143265222"/>
            </identifier>
            <name value="connectathon_Site"/>
            <contact>
              <address>
                <type value="postal"/>
                <text value="connectathon_Site, Restful Rd, Danbury, CT, USA"/>
                <line value="Restful Rd"/>
                <city value="Danbury"/>
                <state value="CT"/>
                <postalCode value="06811"/>
                <country value="USA"/>
              </address>
            </contact>
          </Organization>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d"/>
        <resource>
          <SubstanceDefinition>
            <id value="58ae52aa-c81e-415a-8791-e67a3195290d"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"/>
            </meta>
            <text>
              <status value="generated"/>
              <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>
            </text>
            <identifier>
              <value value="DCM"/>
            </identifier>
            <classification>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C176815"/>
                <display value="Residual Solvent"/>
              </coding>
            </classification>
            <structure>
              <technique>
                <text value="Leftover Solvent"/>
              </technique>
              <representation>
                <type>
                  <coding>
                    <system
                            value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                    <code value="C45253"/>
                  </coding>
                </type>
                <representation value="YMWUJEATGCHHMB-UHFFFAOYSA-N"/>
                <format>
                  <coding>
                    <system
                            value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                    <code value="C54683"/>
                    <display value="InChI File (small molecule)"/>
                  </coding>
                </format>
              </representation>
              <representation>
                <type>
                  <coding>
                    <system
                            value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                    <code value="C45253"/>
                  </coding>
                </type>
                <representation value="ClCCl"/>
                <format>
                  <coding>
                    <system
                            value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                    <code value="C54684"/>
                    <display value="SMILES"/>
                  </coding>
                </format>
              </representation>
            </structure>
            <code>
              <code>
                <coding>
                  <system value="http://fdasis.nlm.nih.gov"/>
                  <code value="588X2YUY0A"/>
                </coding>
              </code>
            </code>
            <name>
              <name value="DICHLOROMETHANE"/>
              <type>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C97054"/>
                  <display value="Generic Name"/>
                </coding>
              </type>
              <preferred value="true"/>
            </name>
          </SubstanceDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989"/>
        <resource>
          <SubstanceDefinition>
            <id value="ffa30c0b-8031-436a-87f1-635b3bbe5989"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"/>
            </meta>
            <text>
              <status value="generated"/>
              <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>
            </text>
            <identifier>
              <value value="hydroxyApatite"/>
            </identifier>
            <classification>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C176816"/>
                <display value="Degradation Product"/>
              </coding>
            </classification>
            <structure>
              <technique>
                <text value="formed from dicalcium phosphate degradation"/>
              </technique>
              <representation>
                <type>
                  <coding>
                    <system
                            value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                    <code value="C45253"/>
                  </coding>
                </type>
                <representation value="XZFUZCHOJLQYHV-UHFFFAOYSA-M"/>
                <format>
                  <coding>
                    <system
                            value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                    <code value="C54683"/>
                    <display value="InChI File (small molecule)"/>
                  </coding>
                </format>
              </representation>
              <representation>
                <type>
                  <coding>
                    <system
                            value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                    <code value="C45253"/>
                  </coding>
                </type>
                <representation
                                value="[OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O"/>
                <format>
                  <coding>
                    <system
                            value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                    <code value="C54684"/>
                    <display value="SMILES"/>
                  </coding>
                </format>
              </representation>
            </structure>
            <code>
              <code>
                <coding>
                  <system value="http://fdasis.nlm.nih.gov"/>
                  <code value="91D9GV0Z28"/>
                </coding>
              </code>
            </code>
            <name>
              <name value="TRIBASIC CALCIUM PHOSPHATE"/>
              <type>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C203355"/>
                  <display value="GSRS Preferred Term"/>
                </coding>
              </type>
              <preferred value="true"/>
            </name>
          </SubstanceDefinition>
        </resource>
      </entry>
    </Bundle>