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.S.2.3 Bundle - JSON Representation

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    {
      "resourceType" : "Bundle",
      "id" : "ControlMaterialsBundle",
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          🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s23"
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      "type" : "document",
      "timestamp" : "2023-12-05T01:34:39.503Z",
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            "resourceType" : "Composition",
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                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23"
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            "author" : [
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            "meta" : {
              "profile" : [
                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"
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            "text" : {
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              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_cd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition cd84a8b5-4e96-551c-15c6-c97c943eb38a</b></p><a name=\"cd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </a><a name=\"hccd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </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>identifier</b>: salicylate</p><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-ControlMaterialsBundle.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+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><blockquote><p><b>name</b></p><p><b>name</b>: ACETYLSALICYLIC ACID</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C97054}\">Generic Name</span></p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: ASPIRIN</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></p><p><b>preferred</b>: true</p></blockquote></div>"
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            "grade" : [
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            "manufacturer" : [
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            "code" : [
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                "code" : {
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                      "system" : "http://fdasis.nlm.nih.gov",
                      "code" : "R16CO5Y76E"
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            "name" : [
              {
                "name" : "ACETYLSALICYLIC ACID",
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          "resource" : {
            "resourceType" : "Organization",
            "id" : "4b565cf3-5353-48af-8cd6-5ccf4e9fd579",
            "meta" : {
              "profile" : [
                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
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            },
            "text" : {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_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>"
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                "system" : "urn:oid:2.16.840.1.113883.4.82",
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            "name" : "Manufacturing Site (J. Jones Research)",
            "contact" : [
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                  "text" : "Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States",
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                  "city" : "Bedford",
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        {
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          "resource" : {
            "resourceType" : "Organization",
            "id" : "e99bddfa-c1b5-435b-bbe8-24816b4e23e5",
            "meta" : {
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                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
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            "text" : {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization e99bddfa-c1b5-435b-bbe8-24816b4e23e5</b></p><a name=\"e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><a name=\"hce99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </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, FEI/6981397</p><p><b>name</b>: Vidinaid</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>Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA</td></tr></table></div>"
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              {
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                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                      "code" : "C134004",
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                  ]
                },
                "system" : "urn:oid:2.16.840.1.113883.4.82",
                "value" : "6981397"
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            ],
            "name" : "Vidinaid",
            "contact" : [
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                "address" : {
                  "type" : "postal",
                  "text" : "Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA",
                  "line" : [
                    "100 Stillwater Avenue",
                    "Building #2"
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                  "city" : "Bangor",
                  "state" : "ME",
                  "postalCode" : "04401",
                  "country" : "USA"
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        },
        {
          "fullUrl" : "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049",
          "resource" : {
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            "id" : "d9e7c2f7-0f59-4645-bb6d-5a8dd2425049",
            "meta" : {
              "profile" : [
                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
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            },
            "text" : {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</b></p><a name=\"d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><a name=\"hcd9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </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/173265332</p><p><b>name</b>: Mega Chem Supply</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>Mega Chem Supply, 350 W Main Street, Rochester, NY, United States</td></tr></table></div>"
            },
            "identifier" : [
              {
                "type" : {
                  "coding" : [
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                },
                "system" : "urn:oid:1.3.6.1.4.1.519.1",
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            "name" : "Mega Chem Supply",
            "contact" : [
              {
                "address" : {
                  "type" : "postal",
                  "text" : "Mega Chem Supply, 350 W Main Street, Rochester, NY, United States",
                  "line" : [
                    "350 W Main Street"
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                  "city" : "Rochester",
                  "state" : "NY",
                  "postalCode" : "14608",
                  "country" : "USA"
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              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703",
          "resource" : {
            "resourceType" : "SubstanceDefinition",
            "id" : "0efb1188-04f0-44ba-bfe7-ca6169ca8703",
            "meta" : {
              "profile" : [
                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
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            },
            "text" : {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_0efb1188-04f0-44ba-bfe7-ca6169ca8703\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 0efb1188-04f0-44ba-bfe7-ca6169ca8703</b></p><a name=\"0efb1188-04f0-44ba-bfe7-ca6169ca8703\"> </a><a name=\"hc0efb1188-04f0-44ba-bfe7-ca6169ca8703\"> </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>identifier</b>: carrageenan</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C103206}\">Structurally Diverse Substance</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134009}\">Company Standard</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 5C69YCD2YJ}\">5C69YCD2YJ</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>Carrageenan</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:\">palmaria</span></td><td><span title=\"Codes:\">palmata</span></td><td><span title=\"Codes:\">whole</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 USA}\">United States of America</span></td></tr></table></div>"
            },
            "identifier" : [
              {
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            ],
            "classification" : [
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                "coding" : [
                  {
                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code" : "C103206",
                    "display" : "Structurally Diverse Substance"
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            "grade" : [
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                    "code" : "C134009",
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            "manufacturer" : [
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                "reference" : "urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579"
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            ],
            "code" : [
              {
                "code" : {
                  "coding" : [
                    {
                      "system" : "http://fdasis.nlm.nih.gov",
                      "code" : "5C69YCD2YJ"
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                  ]
                }
              }
            ],
            "name" : [
              {
                "name" : "Carrageenan",
                "type" : {
                  "coding" : [
                    {
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                      "display" : "GSRS Preferred Term"
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                  ]
                },
                "preferred" : true
              }
            ],
            "sourceMaterial" : {
              "type" : {
                "coding" : [
                  {
                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code" : "C14258",
                    "display" : "Plant"
                  }
                ]
              },
              "genus" : {
                "text" : "palmaria"
              },
              "species" : {
                "text" : "palmata"
              },
              "part" : {
                "text" : "whole"
              },
              "countryOfOrigin" : [
                {
                  "coding" : [
                    {
                      "system" : "urn:iso:std:iso:3166",
                      "code" : "USA",
                      "display" : "United States of America"
                    }
                  ]
                }
              ]
            }
          }
        },
        {
          "fullUrl" : "urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a",
          "resource" : {
            "resourceType" : "SubstanceDefinition",
            "id" : "fd84a8b5-9e96-451c-a5c6-097c943eb38a",
            "meta" : {
              "profile" : [
                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
              ]
            },
            "text" : {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_fd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition fd84a8b5-9e96-451c-a5c6-097c943eb38a</b></p><a name=\"fd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </a><a name=\"hcfd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </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>identifier</b>: Citric acid</p><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 C134009}\">Company Standard</span></p><p><b>manufacturer</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+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 XF417D3PSL}\">XF417D3PSL</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>ANHYDROUS CITRIC ACID</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>"
            },
            "identifier" : [
              {
                "value" : "Citric acid"
              }
            ],
            "classification" : [
              {
                "coding" : [
                  {
                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code" : "C48807",
                    "display" : "Chemical"
                  }
                ]
              }
            ],
            "grade" : [
              {
                "coding" : [
                  {
                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code" : "C134009",
                    "display" : "Company Standard"
                  }
                ]
              }
            ],
            "manufacturer" : [
              {
                "reference" : "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"
              }
            ],
            "supplier" : [
              {
                "reference" : "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"
              }
            ],
            "code" : [
              {
                "code" : {
                  "coding" : [
                    {
                      "system" : "http://fdasis.nlm.nih.gov",
                      "code" : "XF417D3PSL"
                    }
                  ]
                }
              }
            ],
            "name" : [
              {
                "name" : "ANHYDROUS CITRIC ACID",
                "type" : {
                  "coding" : [
                    {
                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                      "code" : "C203355",
                      "display" : "GSRS Preferred Term"
                    }
                  ]
                },
                "preferred" : true
              }
            ],
            "sourceMaterial" : {
              "type" : {
                "coding" : [
                  {
                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code" : "C48807",
                    "display" : "Chemical"
                  }
                ]
              }
            }
          }
        },
        {
          "fullUrl" : "urn:uuid:d3a11b25-e160-4688-b807-6383364096fd",
          "resource" : {
            "resourceType" : "SubstanceDefinition",
            "id" : "d3a11b25-e160-4688-b807-6383364096fd",
            "meta" : {
              "profile" : [
                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
              ]
            },
            "text" : {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_d3a11b25-e160-4688-b807-6383364096fd\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition d3a11b25-e160-4688-b807-6383364096fd</b></p><a name=\"d3a11b25-e160-4688-b807-6383364096fd\"> </a><a name=\"hcd3a11b25-e160-4688-b807-6383364096fd\"> </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>identifier</b>: water</p><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 C176793}\">BP</span></p><p><b>manufacturer</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+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 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>"
            },
            "identifier" : [
              {
                "value" : "water"
              }
            ],
            "classification" : [
              {
                "coding" : [
                  {
                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code" : "C48807",
                    "display" : "Chemical"
                  }
                ]
              }
            ],
            "grade" : [
              {
                "coding" : [
                  {
                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code" : "C176793",
                    "display" : "BP"
                  }
                ]
              }
            ],
            "manufacturer" : [
              {
                "reference" : "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"
              }
            ],
            "supplier" : [
              {
                "reference" : "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"
              }
            ],
            "code" : [
              {
                "code" : {
                  "coding" : [
                    {
                      "system" : "http://fdasis.nlm.nih.gov",
                      "code" : "059QF0KO0R"
                    }
                  ]
                }
              }
            ],
            "name" : [
              {
                "name" : "WATER",
                "type" : {
                  "coding" : [
                    {
                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                      "code" : "C203355",
                      "display" : "GSRS Preferred Term"
                    }
                  ]
                },
                "preferred" : true
              }
            ],
            "sourceMaterial" : {
              "type" : {
                "coding" : [
                  {
                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code" : "C48807",
                    "display" : "Chemical"
                  }
                ]
              }
            }
          }
        },
        {
          "fullUrl" : "urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e",
          "resource" : {
            "resourceType" : "PlanDefinition",
            "id" : "ab241f8c-d21e-4382-a70a-52190dbdf07e",
            "meta" : {
              "profile" : [
                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"
              ]
            },
            "text" : {
              "status" : "extensions",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_ab241f8c-d21e-4382-a70a-52190dbdf07e\"> </a>\n<div>\n    <table class=\"grid dict\">\n        \n        <tr>\n            <th scope=\"row\"><b>Id: </b></th>\n            <td style=\"padding-left: 4px;\">ab241f8c-d21e-4382-a70a-52190dbdf07e</td>\n        </tr>\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Version: </b></th>\n            <td style=\"padding-left: 4px;\">1.0</td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\">\n                <b>\n                    \n                        \n                    \n                </b>\n            </th>\n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <span>RawCitricacid</span>\n                </p>\n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Title: </b></th>\n            <td style=\"padding-left: 4px;\">Raw Material (Carrageenan) Specification Example</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Type: </b></th>\n            <td style=\"padding-left: 4px;\">\n                \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"http://terminology.hl7.org/6.4.0/CodeSystem-plan-definition-type.html\">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>workflow-definition</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Workflow Definition</span>\n                        </p>\n                        \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>C133931</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Raw Materials/Excipients/Intermediates/Reagents</span>\n                        </p>\n                        \n                    \n                \n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Subject: </b></th>\n            \n            \n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <b>reference: </b> <span>urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703</span>\n                </p>\n                \n                \n                \n            </td>\n            \n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Date: </b></th>\n            <td style=\"padding-left: 4px;\">2023-11-28</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Actions: </b></th>\n            <td style=\"padding-left: 4px;\">\n                <table class=\"grid-dict\">\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Identification:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            <b>Then:</b>\n                            <table class=\"grid-dict\">\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Identification A:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Identification B:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Identification C:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Identification D:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                            </table>\n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Microbial Limits:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            <b>Then:</b>\n                            <table class=\"grid-dict\">\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Total Bacterial Count:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Salmonella:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Escherichia Coli:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                            </table>\n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Elemental Impurities:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            <b>Then:</b>\n                            <table class=\"grid-dict\">\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Cadmium (Cd):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Mercury (Hg):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Arsenic (As):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Lead (Pb):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                            </table>\n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Residual Solvents:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Impurity: Insoluble Matter:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Solubility in H2O:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                </table>\n            </td>\n        </tr>\n        \n    </table>\n</div>\n</div>"
            },
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension",
                "valueCodeableConcept" : {
                  "coding" : [
                    {
                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                      "code" : "C48660",
                      "display" : "Not Applicable"
                    }
                  ]
                }
              }
            ],
            "identifier" : [
              {
                "value" : "RawCitricacid"
              }
            ],
            "version" : "1.0",
            "title" : "Raw Material (Carrageenan) Specification Example",
            "type" : {
              "coding" : [
                {
                  "system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type",
                  "code" : "workflow-definition",
                  "display" : "Workflow Definition"
                },
                {
                  "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                  "code" : "C133931",
                  "display" : "Raw Materials/Excipients/Intermediates/Reagents"
                }
              ]
            },
            "status" : "active",
            "subjectReference" : {
              "reference" : "urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703"
            },
            "date" : "2023-11-28",
            "goal" : [
              {
                "id" : "e512320e-0ffb-47d9-922a-5415aaa4cb30",
                "description" : {
                  "text" : "Viscous upon cooling"
                },
                "addresses" : [
                  {
                    "coding" : [
                      {
                        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                        "code" : "C134029",
                        "display" : "Release"
                      }
                    ]
                  },
                  {
                    "coding" : [
                      {
                        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                        "code" : "C134030",
                        "display" : "Stability"
                      }
                    ]
                  }
                ],
                "target" : [
                  {
                    "detailString" : "Viscous upon cooling"
                  }
                ]
              },
              {
                "id" : "2c6e465b-4dec-4a09-9dc5-58c480009d27",
                "description" : {
                  "text" : "Kappa, iota or lambda"
                },
                "addresses" : [
                  {
                    "coding" : [
                      {
                        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                        "code" : "C134029",
                        "display" : "Release"
                      }
                    ]
                  },
                  {
                    "coding" : [
                      {
                        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                        "code" : "C134030",
                        "display" : "Stability"
                      }
                    ]
                  }
                ],
                "target" : [
                  {
                    "detailString" : "Kappa, iota or Lambda"
                  }
                ]
              },
              {
                "id" : "c233a5f7-37e2-4b2b-9f04-cf1b25534865",
                "description" : {
                  "text" : "Blue, stringy precipitate forms"
                },
                "addresses" : [
                  {
                    "coding" : [
                      {
                        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                        "code" : "C134029",
                        "display" : "Release"
                      }
                    ]
                  },
                  {
                    "coding" : [
                      {
                        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                        "code" : "C134030",
                        "display" : "Stability"
                      }
                    ]
                  }
                ],
                "target" : [
                  {
                    "detailString" : "Blue stringy precipitate forms"
                  }
                ]
              },
              {
                "id" : "c759888d-1eac-4a12-aa9b-403f395f2c18",
                "description" : {
                  "text" : "FTIR matches standard"
                },
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               \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Subject: </b></th>\n            \n            \n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <b>reference: </b> <span>urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a</span>\n                </p>\n                \n                \n                \n            </td>\n            \n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Date: </b></th>\n            <td style=\"padding-left: 4px;\">2023-12-01</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Actions: </b></th>\n            <td style=\"padding-left: 4px;\">\n                <table class=\"grid-dict\">\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Appearance:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Identification:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage [pH]:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Residue on Ignition:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                </table>\n            </td>\n        </tr>\n        \n    </table>\n</div>\n</div>"
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                  "text" : "FTIR"
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                "prefix" : "Single Stage",
                "title" : "[pH]",
                "code" : {
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                      "code" : "C96103",
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                  "text" : "Visual"
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                "title" : "Residue on Ignition",
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                      "code" : "C96102",
                      "display" : "Compendial"
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                  "text" : "Visual"
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          "resource" : {
            "resourceType" : "PlanDefinition",
            "id" : "5819b223-d3d2-419f-b617-b3a9a3625b89",
            "meta" : {
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                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"
              ]
            },
            "text" : {
              "status" : "extensions",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_5819b223-d3d2-419f-b617-b3a9a3625b89\"> </a>\n<div>\n    <table class=\"grid dict\">\n        \n        <tr>\n            <th scope=\"row\"><b>Id: </b></th>\n            <td style=\"padding-left: 4px;\">5819b223-d3d2-419f-b617-b3a9a3625b89</td>\n        </tr>\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Version: </b></th>\n            <td style=\"padding-left: 4px;\">1.0</td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\">\n                <b>\n                    \n                        \n                    \n                </b>\n            </th>\n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <span>WaterSpecification</span>\n                </p>\n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Title: </b></th>\n            <td style=\"padding-left: 4px;\">Water Specification Example</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Type: </b></th>\n            <td style=\"padding-left: 4px;\">\n                \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"http://terminology.hl7.org/6.4.0/CodeSystem-plan-definition-type.html\">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>workflow-definition</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Workflow Definition</span>\n                        </p>\n                        \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>C133931</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Raw Materials/Excipients/Intermediates/Reagents</span>\n                        </p>\n                        \n                    \n                \n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Subject: </b></th>\n            \n            \n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <b>reference: </b> <span>urn:uuid:d3a11b25-e160-4688-b807-6383364096fd</span>\n                </p>\n                \n                \n                \n            </td>\n            \n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Date: </b></th>\n            <td style=\"padding-left: 4px;\">2023-12-01</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Actions: </b></th>\n            <td style=\"padding-left: 4px;\">\n                <table class=\"grid-dict\">\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Color degree:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Turbidity:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Smell and taste:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Total hardness:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                </table>\n            </td>\n        </tr>\n        \n    </table>\n</div>\n</div>"
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