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.3.2 Bundle for two-layer tablet - XML Representation

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    <Bundle xmlns="http://hl7.org/fhir">
      <id value="BatchFormulaBundle2Layer"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p32"/>
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      <identifier>
        <system value="urn:ietf:rfc:3986"/>
        <value value="urn:uuid:49d3b79e-b436-a242-93ba-b706b4364ab2"/>
      </identifier>
      <type value="document"/>
      <timestamp value="2024-08-29T12:34:56.789Z"/>
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        <fullUrl value="urn:uuid:c00b0003-c2bf-7547-8b1c-f1f399f99d5c"/>
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              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p32"/>
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              <div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_c00b0003-c2bf-7547-8b1c-f1f399f99d5c"> </a><p class="res-header-id"><b>Generated Narrative: Composition c00b0003-c2bf-7547-8b1c-f1f399f99d5c</b></p><a name="c00b0003-c2bf-7547-8b1c-f1f399f99d5c"> </a><a name="hcc00b0003-c2bf-7547-8b1c-f1f399f99d5c"> </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-32p32.html">eCTD Batch Formula</a></p></div><p><b>identifier</b>: BatchFormulaComposition2layer</p><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.p.3.2}">m3.2.p.3.2 batch formula</span></p><p><b>date</b>: 2024-08-01 12:34:56+0000</p><p><b>author</b>: <a href="Bundle-BatchFormulaBundle.html#urn-uuid-4f3e9af1-306b-4fad-bf04-7881400b266a">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></p><p><b>title</b>: Batch formula example two layer tablet</p></div>
            </text>
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              <value value="BatchFormulaComposition2layer"/>
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            <status value="final"/>
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              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/ICHContextOfUse"/>
                <code value="ich_3.2.p.3.2"/>
                <display value="m3.2.p.3.2 batch formula"/>
              </coding>
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            <date value="2024-08-01T12:34:56.789Z"/>
            <author>
              <reference value="urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"/>
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            <title value="Batch formula example two layer tablet"/>
            <section>
              <title value="Batch Formula"/>
              <code>
                <coding>
                  <system
                          value="http://terminology.hl7.org/CodeSystem/ICHContextOfUse"/>
                  <code value="ich_3.2.p.3.2"/>
                  <display value="m3.2.p.3.2 batch formula"/>
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                <reference value="urn:uuid:f0f3ff35-5cfa-6617-b8f1-b8167957f53c"/>
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            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
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            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><p class="res-header-id"><b>Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a</b></p><a name="4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><a name="hc4f3e9af1-306b-4fad-bf04-7881400b266a"> </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>: Wunderwerke</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>Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478</td></tr></table></div>
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            <identifier>
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                  <system
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                  <code value="C134003"/>
                  <display value="DUNS"/>
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              <system value="urn:oid:1.3.6.1.4.1.519.1"/>
              <value value="143265222"/>
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            <name value="Wunderwerke"/>
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                <type value="postal"/>
                <text
                      value="Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478"/>
                <line value="123 Scenic Road"/>
                <city value="Bridgeport"/>
                <state value="CT"/>
                <postalCode value="65478"/>
                <country value="USA"/>
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            <meta>
              <profile
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            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_b69435a0-45c6-4d44-9fde-b354e17408d7"> </a><p class="res-header-id"><b>Generated Narrative: Organization b69435a0-45c6-4d44-9fde-b354e17408d7</b></p><a name="b69435a0-45c6-4d44-9fde-b354e17408d7"> </a><a name="hcb69435a0-45c6-4d44-9fde-b354e17408d7"> </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>: Large Life</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>123 Broad Way, New York, NY, United States</td></tr></table></div>
            </text>
            <identifier>
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                <coding>
                  <system
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                  <code value="C134003"/>
                  <display value="DUNS"/>
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              <system value="urn:oid:1.3.6.1.4.1.519.1"/>
              <value value="143265222"/>
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            <name value="Large Life"/>
            <contact>
              <address>
                <type value="postal"/>
                <text value="123 Broad Way, New York, NY, United States"/>
                <line value="123 Broad Way"/>
                <city value="New York"/>
                <state value="NY"/>
                <postalCode value="10020"/>
                <country value="USA"/>
              </address>
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          </Organization>
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      <entry>
        <fullUrl value="urn:uuid:f0f3ff35-5cfa-6617-b8f1-b8167957f53c"/>
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          <MedicinalProductDefinition>
            <id value="f0f3ff35-5cfa-6617-b8f1-b8167957f53c"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-batch-formula-product"/>
            </meta>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_f0f3ff35-5cfa-6617-b8f1-b8167957f53c"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition f0f3ff35-5cfa-6617-b8f1-b8167957f53c</b></p><a name="f0f3ff35-5cfa-6617-b8f1-b8167957f53c"> </a><a name="hcf0f3ff35-5cfa-6617-b8f1-b8167957f53c"> </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-batch-formula-product.html">Batch Formula Drug Product Identification</a></p></div><p><b>identifier</b>: ASPIRIN-ACETAMINOPHEN-Identification</p><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><p><b>comprisedOf</b>: <a href="Bundle-BatchFormulaBundle2Layer.html#urn-uuid-8a3e11d9-4323-43c4-be00-8f0ea1837070">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><blockquote><p><b>name</b></p><p><b>productName</b>: ASPIRIN 200mg, ACETAMINOPHEN 300mg</p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C96971}">Nonproprietary Name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: ASPIRIN</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>: 200mg</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}">ASPIRIN</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: ACETAMINOPHEN</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>: 300mg</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}">ACETAMINOPHEN</span></p></blockquote></blockquote></div>
            </text>
            <identifier>
              <value value="ASPIRIN-ACETAMINOPHEN-Identification"/>
            </identifier>
            <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>
            <comprisedOf>
              <reference value="urn:uuid:8a3e11d9-4323-43c4-be00-8f0ea1837070"/>
            </comprisedOf>
            <name>
              <productName value="ASPIRIN 200mg, ACETAMINOPHEN 300mg"/>
              <type>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C96971"/>
                  <display value="Nonproprietary Name"/>
                </coding>
              </type>
              <part>
                <part value="ASPIRIN"/>
                <type>
                  <coding>
                    <system
                            value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
                    <code value="SCI"/>
                  </coding>
                </type>
              </part>
              <part>
                <part value="200mg"/>
                <type>
                  <coding>
                    <system
                            value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
                    <code value="STR"/>
                  </coding>
                  <text value="ASPIRIN"/>
                </type>
              </part>
              <part>
                <part value="ACETAMINOPHEN"/>
                <type>
                  <coding>
                    <system
                            value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
                    <code value="SCI"/>
                  </coding>
                </type>
              </part>
              <part>
                <part value="300mg"/>
                <type>
                  <coding>
                    <system
                            value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
                    <code value="STR"/>
                  </coding>
                  <text value="ACETAMINOPHEN"/>
                </type>
              </part>
            </name>
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      </entry>
      <entry>
        <fullUrl value="urn:uuid:8a3e11d9-4323-43c4-be00-8f0ea1837070"/>
        <resource>
          <ManufacturedItemDefinition>
            <id value="8a3e11d9-4323-43c4-be00-8f0ea1837070"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula"/>
            </meta>
            <text>
              <status value="extensions"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_8a3e11d9-4323-43c4-be00-8f0ea1837070"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition 8a3e11d9-4323-43c4-be00-8f0ea1837070</b></p><a name="8a3e11d9-4323-43c4-be00-8f0ea1837070"> </a><a name="hc8a3e11d9-4323-43c4-be00-8f0ea1837070"> </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-product-batch-formula.html">Drug Product Batch Formula</a></p></div><p><b>identifier</b>: ASPIRIN-ACETAMINOPHEN</p><p><b>status</b>: Active</p><p><b>name</b>: ASPIRIN 200mg, ACETAMINOPHEN 300mg 2000 tablets</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C154605}">Tablet</span></p><p><b>manufacturer</b>: <a href="Bundle-BatchFormulaBundle2Layer.html#urn-uuid-b69435a0-45c6-4d44-9fde-b354e17408d7">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Batch Quantity</span></p><p><b>value</b>: 2000 tablets<span style="background: LightGoldenRodYellow"> (Details: UCUM  code{tbl} = '{tbl}')</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Batch Utilization</span></p><p><b>value</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C133991}">Development</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Batch Formula Additional Information</span></p><p><b>value</b>: </p><div><p>Makes 2000 tablets equivalent to 2.402 kilograms, accounting for losses from evaporation</p>
    </div></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C66831}">Layer</span></p><p><b>amount</b>: 925.97 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM  codeg = 'g')</span>, 38.55 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</span></p><blockquote><p><b>constituent</b></p><p><b>amount</b>: 400 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM  codeg = 'g')</span>, 43.1 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</span></p><p><b>location</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203881}">Purple Layer</span></p><h3>HasIngredients</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-BatchFormulaBundle2Layer.html#urn-uuid-d4713a90-38d1-49e5-a977-78c63e518562">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 524.01 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM  codeg = 'g')</span>, 56.59 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</span></p><p><b>location</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203883}">Purple Layer</span></p><h3>HasIngredients</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-BatchFormulaBundle2Layer.html#urn-uuid-9973ba9a-b257-425a-8fb9-6dcfe379ca08">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 203.71 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM  codeg = 'g')</span>, 22 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</span></p><p><b>location</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203882}">Purple Layer</span></p><h3>HasIngredients</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-BatchFormulaBundle2Layer.html#urn-uuid-4e394a0c-4b25-492e-aac7-0faf121ffc4f">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><blockquote><p><b>Overage Extension</b></p><ul><li>proportionDecimal: 0.02</li><li>justification: </li></ul></blockquote><div><p>Evaporation</p>
    </div><p><b>amount</b>: 311.68 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM  codeg = 'g')</span>, 33 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</span></p><p><b>location</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203882}">Purple Layer</span></p><h3>HasIngredients</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-BatchFormulaBundle2Layer.html#urn-uuid-95648837-ec81-42d9-970c-eac390f2f604">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><h3>Properties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Product Part Identifier</span></td><td><span title="Codes:">Purple Layer</span></td></tr></table></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C66831}">Layer</span></p><p><b>amount</b>: 1476.03 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM  codeg = 'g')</span>, 61.45 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</span></p><blockquote><p><b>constituent</b></p><p><b>amount</b>: 600.01 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM  codeg = 'g')</span>, 40.65 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</span></p><p><b>location</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203881}">Example1Drug_LayerB</span></p><h3>HasIngredients</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-BatchFormulaBundle2Layer.html#urn-uuid-fbd464cc-2511-4a3a-b058-3cec4fffd14f">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 876.02 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM  codeg = 'g')</span>, 59.35 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</span></p><p><b>location</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203883}">Example1Drug_LayerB</span></p><h3>HasIngredients</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-BatchFormulaBundle2Layer.html#urn-uuid-9973ba9a-b257-425a-8fb9-6dcfe379ca08">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 369.01 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM  codeg = 'g')</span>, 25 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</span></p><p><b>location</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203882}">Example1Drug_LayerB</span></p><h3>HasIngredients</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-BatchFormulaBundle2Layer.html#urn-uuid-95648837-ec81-42d9-970c-eac390f2f604">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><h3>Properties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Product Part Identifier</span></td><td><span title="Codes:">Example1Drug_LayerB</span></td></tr></table></blockquote></div>
            </text>
            <identifier>
              <value value="ASPIRIN-ACETAMINOPHEN"/>
            </identifier>
            <status value="active"/>
            <name value="ASPIRIN 200mg, ACETAMINOPHEN 300mg 2000 tablets"/>
            <manufacturedDoseForm>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C154605"/>
                <display value="Tablet"/>
              </coding>
            </manufacturedDoseForm>
            <manufacturer>
              <reference value="urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7"/>
            </manufacturer>
            <property>
              <type>
                <text value="Batch Quantity"/>
              </type>
              <valueQuantity>
                <value value="2000"/>
                <unit value="tablets"/>
                <system value="http://unitsofmeasure.org"/>
                <code value="{tbl}"/>
              </valueQuantity>
            </property>
            <property>
              <type>
                <text value="Batch Utilization"/>
              </type>
              <valueCodeableConcept>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C133991"/>
                  <display value="Development"/>
                </coding>
              </valueCodeableConcept>
            </property>
            <property>
              <type>
                <text value="Batch Formula Additional Information"/>
              </type>
              <valueMarkdown
                             value="Makes 2000 tablets equivalent to 2.402 kilograms, accounting for losses from evaporation"/>
            </property>
            <component>
              <type>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C66831"/>
                  <display value="Layer"/>
                </coding>
              </type>
              <amount>
                <value value="925.97"/>
                <unit value="gram"/>
                <system value="http://unitsofmeasure.org"/>
                <code value="g"/>
              </amount>
              <amount>
                <value value="38.55"/>
                <unit value="percent"/>
                <system value="http://unitsofmeasure.org"/>
                <code value="%"/>
              </amount>
              <constituent>
                <amount>
                  <value value="400"/>
                  <unit value="gram"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="g"/>
                </amount>
                <amount>
                  <value value="43.1"/>
                  <unit value="percent"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </amount>
                <location>
                  <coding>
                    <system
                            value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                    <code value="C203881"/>
                    <display value="Active core/granulate"/>
                  </coding>
                  <text value="Purple Layer"/>
                </location>
                <hasIngredient>
                  <reference>
                    <reference
                               value="urn:uuid:d4713a90-38d1-49e5-a977-78c63e518562"/>
                  </reference>
                </hasIngredient>
              </constituent>
              <constituent>
                <amount>
                  <value value="524.01"/>
                  <unit value="gram"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="g"/>
                </amount>
                <amount>
                  <value value="56.59"/>
                  <unit value="percent"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </amount>
                <location>
                  <coding>
                    <system
                            value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                    <code value="C203883"/>
                    <display value="Intragranular"/>
                  </coding>
                  <text value="Purple Layer"/>
                </location>
                <hasIngredient>
                  <reference>
                    <reference
                               value="urn:uuid:9973ba9a-b257-425a-8fb9-6dcfe379ca08"/>
                  </reference>
                </hasIngredient>
              </constituent>
              <constituent>
                <amount>
                  <value value="203.71"/>
                  <unit value="gram"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="g"/>
                </amount>
                <amount>
                  <value value="22"/>
                  <unit value="percent"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </amount>
                <location>
                  <coding>
                    <system
                            value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                    <code value="C203882"/>
                    <display value="Extragranular"/>
                  </coding>
                  <text value="Purple Layer"/>
                </location>
                <hasIngredient>
                  <reference>
                    <reference
                               value="urn:uuid:4e394a0c-4b25-492e-aac7-0faf121ffc4f"/>
                  </reference>
                </hasIngredient>
              </constituent>
              <constituent>
                <extension
                           url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension">
                  <extension url="proportionDecimal">
                    <valueDecimal value="0.02"/>
                  </extension>
                  <extension url="justification">
                    <valueMarkdown value="Evaporation"/>
                  </extension>
                </extension>
                <amount>
                  <value value="311.68"/>
                  <unit value="gram"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="g"/>
                </amount>
                <amount>
                  <value value="33"/>
                  <unit value="percent"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </amount>
                <location>
                  <coding>
                    <system
                            value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                    <code value="C203882"/>
                    <display value="Extragranular"/>
                  </coding>
                  <text value="Purple Layer"/>
                </location>
                <hasIngredient>
                  <reference>
                    <reference
                               value="urn:uuid:95648837-ec81-42d9-970c-eac390f2f604"/>
                  </reference>
                </hasIngredient>
              </constituent>
              <property>
                <type>
                  <text value="Product Part Identifier"/>
                </type>
                <valueCodeableConcept>
                  <text value="Purple Layer"/>
                </valueCodeableConcept>
              </property>
            </component>
            <component>
              <type>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C66831"/>
                  <display value="Layer"/>
                </coding>
              </type>
              <amount>
                <value value="1476.03"/>
                <unit value="gram"/>
                <system value="http://unitsofmeasure.org"/>
                <code value="g"/>
              </amount>
              <amount>
                <value value="61.45"/>
                <unit value="percent"/>
                <system value="http://unitsofmeasure.org"/>
                <code value="%"/>
              </amount>
              <constituent>
                <amount>
                  <value value="600.01"/>
                  <unit value="gram"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="g"/>
                </amount>
                <amount>
                  <value value="40.65"/>
                  <unit value="percent"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </amount>
                <location>
                  <coding>
                    <system
                            value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                    <code value="C203881"/>
                    <display value="Active core/granulate"/>
                  </coding>
                  <text value="Example1Drug_LayerB"/>
                </location>
                <hasIngredient>
                  <reference>
                    <reference
                               value="urn:uuid:fbd464cc-2511-4a3a-b058-3cec4fffd14f"/>
                  </reference>
                </hasIngredient>
              </constituent>
              <constituent>
                <amount>
                  <value value="876.02"/>
                  <unit value="gram"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="g"/>
                </amount>
                <amount>
                  <value value="59.35"/>
                  <unit value="percent"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </amount>
                <location>
                  <coding>
                    <system
                            value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                    <code value="C203883"/>
                    <display value="Intragranular"/>
                  </coding>
                  <text value="Example1Drug_LayerB"/>
                </location>
                <hasIngredient>
                  <reference>
                    <reference
                               value="urn:uuid:9973ba9a-b257-425a-8fb9-6dcfe379ca08"/>
                  </reference>
                </hasIngredient>
              </constituent>
              <constituent>
                <amount>
                  <value value="369.01"/>
                  <unit value="gram"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="g"/>
                </amount>
                <amount>
                  <value value="25"/>
                  <unit value="percent"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </amount>
                <location>
                  <coding>
                    <system
                            value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                    <code value="C203882"/>
                    <display value="Extragranular"/>
                  </coding>
                  <text value="Example1Drug_LayerB"/>
                </location>
                <hasIngredient>
                  <reference>
                    <reference
                               value="urn:uuid:95648837-ec81-42d9-970c-eac390f2f604"/>
                  </reference>
                </hasIngredient>
              </constituent>
              <property>
                <type>
                  <text value="Product Part Identifier"/>
                </type>
                <valueCodeableConcept>
                  <text value="Example1Drug_LayerB"/>
                </valueCodeableConcept>
              </property>
            </component>
          </ManufacturedItemDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:d4713a90-38d1-49e5-a977-78c63e518562"/>
        <resource>
          <Ingredient>
            <id value="d4713a90-38d1-49e5-a977-78c63e518562"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
            </meta>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_d4713a90-38d1-49e5-a977-78c63e518562"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient d4713a90-38d1-49e5-a977-78c63e518562</b></p><a name="d4713a90-38d1-49e5-a977-78c63e518562"> </a><a name="hcd4713a90-38d1-49e5-a977-78c63e518562"> </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-dp-ingredient.html">Drug Product Batch Formula Ingredient</a></p></div><p><b>identifier</b>: Asprin - Ingredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C82533}">Active Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</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-BatchFormulaBundle2Layer.html#urn-uuid-cbb54715-3928-4e3f-9abe-32914f694957">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 400 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM  codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 10.4 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</span></p></blockquote></blockquote></div>
            </text>
            <identifier>
              <value value="Asprin - Ingredient"/>
            </identifier>
            <status value="active"/>
            <role>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C82533"/>
                <display value="Active Ingredient"/>
              </coding>
            </role>
            <substance>
              <code>
                <reference>
                  <reference
                             value="urn:uuid:cbb54715-3928-4e3f-9abe-32914f694957"/>
                </reference>
              </code>
              <strength>
                <concentrationQuantity>
                  <value value="400"/>
                  <unit value="gram"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="g"/>
                </concentrationQuantity>
              </strength>
              <strength>
                <concentrationQuantity>
                  <value value="10.4"/>
                  <unit value="percent"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </concentrationQuantity>
              </strength>
            </substance>
          </Ingredient>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:fbd464cc-2511-4a3a-b058-3cec4fffd14f"/>
        <resource>
          <Ingredient>
            <id value="fbd464cc-2511-4a3a-b058-3cec4fffd14f"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
            </meta>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_fbd464cc-2511-4a3a-b058-3cec4fffd14f"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient fbd464cc-2511-4a3a-b058-3cec4fffd14f</b></p><a name="fbd464cc-2511-4a3a-b058-3cec4fffd14f"> </a><a name="hcfbd464cc-2511-4a3a-b058-3cec4fffd14f"> </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-dp-ingredient.html">Drug Product Batch Formula Ingredient</a></p></div><p><b>identifier</b>: AcetaminophenIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C82533}">Active Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</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-BatchFormulaBundle2Layer.html#urn-uuid-ca1ff85f-3f05-46be-8cc4-30b076d88c13">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 600 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM  codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 25 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</span></p></blockquote></blockquote></div>
            </text>
            <identifier>
              <value value="AcetaminophenIngredient"/>
            </identifier>
            <status value="active"/>
            <role>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C82533"/>
                <display value="Active Ingredient"/>
              </coding>
            </role>
            <substance>
              <code>
                <reference>
                  <reference
                             value="urn:uuid:ca1ff85f-3f05-46be-8cc4-30b076d88c13"/>
                </reference>
              </code>
              <strength>
                <concentrationQuantity>
                  <value value="600"/>
                  <unit value="gram"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="g"/>
                </concentrationQuantity>
              </strength>
              <strength>
                <concentrationQuantity>
                  <value value="25"/>
                  <unit value="percent"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </concentrationQuantity>
              </strength>
            </substance>
          </Ingredient>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:9973ba9a-b257-425a-8fb9-6dcfe379ca08"/>
        <resource>
          <Ingredient>
            <id value="9973ba9a-b257-425a-8fb9-6dcfe379ca08"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
            </meta>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_9973ba9a-b257-425a-8fb9-6dcfe379ca08"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 9973ba9a-b257-425a-8fb9-6dcfe379ca08</b></p><a name="9973ba9a-b257-425a-8fb9-6dcfe379ca08"> </a><a name="hc9973ba9a-b257-425a-8fb9-6dcfe379ca08"> </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-dp-ingredient.html">Drug Product Batch Formula Ingredient</a></p></div><p><b>identifier</b>: MaizeStarchIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</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-BatchFormulaBundle2Layer.html#urn-uuid-99f4a24f-880f-45f1-8364-8e4e03977b2e">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 1400.03 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM  codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 58.28 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</span></p></blockquote></blockquote></div>
            </text>
            <identifier>
              <value value="MaizeStarchIngredient"/>
            </identifier>
            <status value="active"/>
            <role>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C42637"/>
                <display value="Inactive Ingredient"/>
              </coding>
            </role>
            <substance>
              <code>
                <reference>
                  <reference
                             value="urn:uuid:99f4a24f-880f-45f1-8364-8e4e03977b2e"/>
                </reference>
              </code>
              <strength>
                <concentrationQuantity>
                  <value value="1400.03"/>
                  <unit value="gram"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="g"/>
                </concentrationQuantity>
              </strength>
              <strength>
                <concentrationQuantity>
                  <value value="58.28"/>
                  <unit value="percent"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </concentrationQuantity>
              </strength>
            </substance>
          </Ingredient>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:4e394a0c-4b25-492e-aac7-0faf121ffc4f"/>
        <resource>
          <Ingredient>
            <id value="4e394a0c-4b25-492e-aac7-0faf121ffc4f"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
            </meta>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_4e394a0c-4b25-492e-aac7-0faf121ffc4f"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 4e394a0c-4b25-492e-aac7-0faf121ffc4f</b></p><a name="4e394a0c-4b25-492e-aac7-0faf121ffc4f"> </a><a name="hc4e394a0c-4b25-492e-aac7-0faf121ffc4f"> </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-dp-ingredient.html">Drug Product Batch Formula Ingredient</a></p></div><p><b>identifier</b>: GrapeskinIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</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-BatchFormulaBundle2Layer.html#urn-uuid-a4624559-6c4f-4e90-996d-bc3bf2f5a3f4">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 203.71 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM  codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 8.48 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</span></p></blockquote></blockquote></div>
            </text>
            <identifier>
              <value value="GrapeskinIngredient"/>
            </identifier>
            <status value="active"/>
            <role>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C42637"/>
                <display value="Inactive Ingredient"/>
              </coding>
            </role>
            <substance>
              <code>
                <reference>
                  <reference
                             value="urn:uuid:a4624559-6c4f-4e90-996d-bc3bf2f5a3f4"/>
                </reference>
              </code>
              <strength>
                <concentrationQuantity>
                  <value value="203.71"/>
                  <unit value="gram"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="g"/>
                </concentrationQuantity>
              </strength>
              <strength>
                <concentrationQuantity>
                  <value value="8.48"/>
                  <unit value="percent"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </concentrationQuantity>
              </strength>
            </substance>
          </Ingredient>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:95648837-ec81-42d9-970c-eac390f2f604"/>
        <resource>
          <Ingredient>
            <id value="95648837-ec81-42d9-970c-eac390f2f604"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
            </meta>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_95648837-ec81-42d9-970c-eac390f2f604"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 95648837-ec81-42d9-970c-eac390f2f604</b></p><a name="95648837-ec81-42d9-970c-eac390f2f604"> </a><a name="hc95648837-ec81-42d9-970c-eac390f2f604"> </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-dp-ingredient.html">Drug Product Batch Formula Ingredient</a></p></div><p><b>identifier</b>: WaterBFIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</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-BatchFormulaBundle2Layer.html#urn-uuid-254742fb-7b5b-49f5-b4af-e0d14d81f2f6">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 50.75 kilogram<span style="background: LightGoldenRodYellow"> (Details: UCUM  codekg = 'kg')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 95.3572 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</span></p></blockquote></blockquote></div>
            </text>
            <identifier>
              <value value="WaterBFIngredient"/>
            </identifier>
            <status value="active"/>
            <role>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C42637"/>
                <display value="Inactive Ingredient"/>
              </coding>
            </role>
            <substance>
              <code>
                <reference>
                  <reference
                             value="urn:uuid:254742fb-7b5b-49f5-b4af-e0d14d81f2f6"/>
                </reference>
              </code>
              <strength>
                <concentrationQuantity>
                  <value value="50.75"/>
                  <unit value="kilogram"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="kg"/>
                </concentrationQuantity>
              </strength>
              <strength>
                <concentrationQuantity>
                  <value value="95.3572"/>
                  <unit value="percent"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </concentrationQuantity>
              </strength>
            </substance>
          </Ingredient>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:cbb54715-3928-4e3f-9abe-32914f694957"/>
        <resource>
          <SubstanceDefinition>
            <id value="cbb54715-3928-4e3f-9abe-32914f694957"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"/>
            </meta>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_cbb54715-3928-4e3f-9abe-32914f694957"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition cbb54715-3928-4e3f-9abe-32914f694957</b></p><a name="cbb54715-3928-4e3f-9abe-32914f694957"> </a><a name="hccbb54715-3928-4e3f-9abe-32914f694957"> </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-routine-drug-substance.html">Drug Substance Handle</a></p></div><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}">USP-NF</span></p><p><b>manufacturer</b>: <a href="Bundle-BatchFormulaBundle2Layer.html#urn-uuid-e165f057-5eed-4e64-8328-4438fc88fb1b">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><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 R16CO5Y76E}">R16CO5Y76E</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>ASPIRIN</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>
            <classification>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C48807"/>
                <display value="Chemical"/>
              </coding>
            </classification>
            <grade>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C134006"/>
                <display value="USP-NF"/>
              </coding>
            </grade>
            <manufacturer>
              <reference value="urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b"/>
            </manufacturer>
            <code>
              <code>
                <coding>
                  <system value="http://fdasis.nlm.nih.gov"/>
                  <code value="R16CO5Y76E"/>
                </coding>
              </code>
            </code>
            <name>
              <name value="ASPIRIN"/>
              <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>
      <entry>
        <fullUrl value="urn:uuid:ca1ff85f-3f05-46be-8cc4-30b076d88c13"/>
        <resource>
          <SubstanceDefinition>
            <id value="ca1ff85f-3f05-46be-8cc4-30b076d88c13"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"/>
            </meta>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_ca1ff85f-3f05-46be-8cc4-30b076d88c13"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition ca1ff85f-3f05-46be-8cc4-30b076d88c13</b></p><a name="ca1ff85f-3f05-46be-8cc4-30b076d88c13"> </a><a name="hcca1ff85f-3f05-46be-8cc4-30b076d88c13"> </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-routine-drug-substance.html">Drug Substance Handle</a></p></div><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}">USP-NF</span></p><p><b>manufacturer</b>: <a href="Bundle-BatchFormulaBundle2Layer.html#urn-uuid-4b565cf3-5353-48af-8cd6-5ccf4e9fd579">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><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 362O9ITL9D}">362O9ITL9D</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>ACETAMINOPHEN</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>
            <classification>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C48807"/>
                <display value="Chemical"/>
              </coding>
            </classification>
            <grade>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C134006"/>
                <display value="USP-NF"/>
              </coding>
            </grade>
            <manufacturer>
              <reference value="urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579"/>
            </manufacturer>
            <code>
              <code>
                <coding>
                  <system value="http://fdasis.nlm.nih.gov"/>
                  <code value="362O9ITL9D"/>
                </coding>
              </code>
            </code>
            <name>
              <name value="ACETAMINOPHEN"/>
              <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>
      <entry>
        <fullUrl value="urn:uuid:99f4a24f-880f-45f1-8364-8e4e03977b2e"/>
        <resource>
          <SubstanceDefinition>
            <id value="99f4a24f-880f-45f1-8364-8e4e03977b2e"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
            </meta>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_99f4a24f-880f-45f1-8364-8e4e03977b2e"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition 99f4a24f-880f-45f1-8364-8e4e03977b2e</b></p><a name="99f4a24f-880f-45f1-8364-8e4e03977b2e"> </a><a name="hc99f4a24f-880f-45f1-8364-8e4e03977b2e"> </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-excipient.html">Excipient Drug Substance</a></p></div><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45305}">Mixture</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134009}">Company Standard</span></p><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 O8232NY3SJ}">O8232NY3SJ</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>STARCH, CORN</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><h3>SourceMaterials</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></td></tr></table></div>
            </text>
            <classification>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C45305"/>
                <display value="Mixture"/>
              </coding>
            </classification>
            <grade>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C134009"/>
                <display value="Company Standard"/>
              </coding>
            </grade>
            <code>
              <code>
                <coding>
                  <system value="http://fdasis.nlm.nih.gov"/>
                  <code value="O8232NY3SJ"/>
                </coding>
              </code>
            </code>
            <name>
              <name value="STARCH, CORN"/>
              <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>
            <sourceMaterial>
              <type>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C48807"/>
                  <display value="Chemical"/>
                </coding>
              </type>
            </sourceMaterial>
          </SubstanceDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:a4624559-6c4f-4e90-996d-bc3bf2f5a3f4"/>
        <resource>
          <SubstanceDefinition>
            <id value="a4624559-6c4f-4e90-996d-bc3bf2f5a3f4"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
            </meta>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_a4624559-6c4f-4e90-996d-bc3bf2f5a3f4"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition a4624559-6c4f-4e90-996d-bc3bf2f5a3f4</b></p><a name="a4624559-6c4f-4e90-996d-bc3bf2f5a3f4"> </a><a name="hca4624559-6c4f-4e90-996d-bc3bf2f5a3f4"> </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-excipient.html">Excipient Drug Substance</a></p></div><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45305}">Mixture</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176793}">BP</span></p><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 3GOV20705G}">3GOV20705G</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>WINE GRAPE</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><h3>SourceMaterials</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Genus</b></td><td><b>Species</b></td><td><b>Part</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C14258}">Plant</span></td><td><span title="Codes:">vitis</span></td><td><span title="Codes:">vinifera</span></td><td><span title="Codes:">fruit skin</span></td><td><span title="Codes:{urn:iso:std:iso:3166 ITA}">Italy</span></td></tr></table></div>
            </text>
            <classification>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C45305"/>
                <display value="Mixture"/>
              </coding>
            </classification>
            <grade>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C176793"/>
                <display value="BP"/>
              </coding>
            </grade>
            <code>
              <code>
                <coding>
                  <system value="http://fdasis.nlm.nih.gov"/>
                  <code value="3GOV20705G"/>
                </coding>
              </code>
            </code>
            <name>
              <name value="WINE GRAPE"/>
              <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>
            <sourceMaterial>
              <type>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C14258"/>
                  <display value="Plant"/>
                </coding>
              </type>
              <genus>
                <text value="vitis"/>
              </genus>
              <species>
                <text value="vinifera"/>
              </species>
              <part>
                <text value="fruit skin"/>
              </part>
              <countryOfOrigin>
                <coding>
                  <system value="urn:iso:std:iso:3166"/>
                  <code value="ITA"/>
                  <display value="Italy"/>
                </coding>
              </countryOfOrigin>
            </sourceMaterial>
          </SubstanceDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:254742fb-7b5b-49f5-b4af-e0d14d81f2f6"/>
        <resource>
          <SubstanceDefinition>
            <id value="254742fb-7b5b-49f5-b4af-e0d14d81f2f6"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
            </meta>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_254742fb-7b5b-49f5-b4af-e0d14d81f2f6"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition 254742fb-7b5b-49f5-b4af-e0d14d81f2f6</b></p><a name="254742fb-7b5b-49f5-b4af-e0d14d81f2f6"> </a><a name="hc254742fb-7b5b-49f5-b4af-e0d14d81f2f6"> </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-excipient.html">Excipient Drug Substance</a></p></div><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}">USP-NF</span></p><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 059QF0KO0R}">059QF0KO0R</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>WATER</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><h3>SourceMaterials</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></td></tr></table></div>
            </text>
            <classification>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C48807"/>
                <display value="Chemical"/>
              </coding>
            </classification>
            <grade>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C134006"/>
                <display value="USP-NF"/>
              </coding>
            </grade>
            <code>
              <code>
                <coding>
                  <system value="http://fdasis.nlm.nih.gov"/>
                  <code value="059QF0KO0R"/>
                </coding>
              </code>
            </code>
            <name>
              <name value="WATER"/>
              <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>
            <sourceMaterial>
              <type>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C48807"/>
                  <display value="Chemical"/>
                </coding>
              </type>
            </sourceMaterial>
          </SubstanceDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579"/>
        <resource>
          <Organization>
            <id value="4b565cf3-5353-48af-8cd6-5ccf4e9fd579"/>
            <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_4b565cf3-5353-48af-8cd6-5ccf4e9fd579"> </a><p class="res-header-id"><b>Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579</b></p><a name="4b565cf3-5353-48af-8cd6-5ccf4e9fd579"> </a><a name="hc4b565cf3-5353-48af-8cd6-5ccf4e9fd579"> </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/783452221, FEI/6913973</p><p><b>name</b>: Manufacturing Site (J. Jones Research)</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>Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States</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="783452221"/>
            </identifier>
            <identifier>
              <type>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134004"/>
                  <display value="FEI"/>
                </coding>
              </type>
              <system value="urn:oid:2.16.840.1.113883.4.82"/>
              <value value="6913973"/>
            </identifier>
            <name value="Manufacturing Site (J. Jones Research)"/>
            <contact>
              <address>
                <type value="postal"/>
                <text
                      value="Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States"/>
                <line value="444 Grant Street"/>
                <city value="Bedford"/>
                <state value="NY"/>
                <postalCode value="15600"/>
                <country value="USA"/>
              </address>
            </contact>
          </Organization>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b"/>
        <resource>
          <Organization>
            <id value="e165f057-5eed-4e64-8328-4438fc88fb1b"/>
            <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_e165f057-5eed-4e64-8328-4438fc88fb1b"> </a><p class="res-header-id"><b>Generated Narrative: Organization e165f057-5eed-4e64-8328-4438fc88fb1b</b></p><a name="e165f057-5eed-4e64-8328-4438fc88fb1b"> </a><a name="hce165f057-5eed-4e64-8328-4438fc88fb1b"> </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>: Vandechemie</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>Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium</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="Vandechemie"/>
            <contact>
              <address>
                <type value="postal"/>
                <text
                      value="Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium"/>
                <line value="Ruzettelaan 39234"/>
                <city value="Blankenberge"/>
                <postalCode value="8370"/>
                <country value="BEL"/>
              </address>
            </contact>
          </Organization>
        </resource>
      </entry>
    </Bundle>