Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot 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

: eCTD Document for 32S23 - JSON Representation

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            🔗 "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><a name=\"fd84a8b5-9e96-451c-a5c6-097c943eb38a-en-US\"> </a><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-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+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><a name=\"d3a11b25-e160-4688-b807-6383364096fd-en-US\"> </a><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-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+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" : {
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              {
                "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/6.1.0/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=\"http://terminology.hl7.org/5.1.0/CodeSystem-v3-nciThesaurus.html\">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" : [
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                    "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" : [
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                    "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",
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                    "display" : "Release"
                  }
                ]
              },
              {
                "coding" : [
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                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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                  }
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              }
            ]
          },
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            "id" : "c759888d-1eac-4a12-aa9b-403f395f2c18",
            "description" : {
              "text" : "FTIR matches standard"
            },
            "addresses" : [
              {
                "coding" : [
                  {
                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code" : "C134029",
                    "display" : "Release"
                  }
                ]
              },
              {
                "coding" : [
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                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code" : "C134030",
                    "display" : "Stability"
                  }
                ]
              }
            ],
            "target" : [
              {
                "detailString" : "FTIR matches standard"
              }
            ]
          },
          {
            "id" : "66d4035c-633a-49b1-b974-e3171911f44a",
            "description" : {
              "text" : "max 200 cfu/g"
            },
            "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",
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