FHIR IG analytics| Package | hl7.fhir.us.pq-cmc-fda |
| Resource Type | Bundle |
| Id | Bundle-CharacterisationImpuritiesProductBundle.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
"resourceType": "Bundle",
"id": "CharacterisationImpuritiesProductBundle",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p55"
]
},
"identifier": {
"system": "urn:ietf:rfc:3986",
"value": "urn:uuid:2b738e27-de1f-4f63-8d91-c8860089d2a1"
},
"type": "document",
"timestamp": "2024-04-24T01:12:07.108Z",
"entry": [
{
"fullUrl": "urn:uuid:8a07e353-9cf6-4f27-8a30-2c2d4f439847",
"resource": {
"resourceType": "Composition",
"id": "8a07e353-9cf6-4f27-8a30-2c2d4f439847",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p55"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_8a07e353-9cf6-4f27-8a30-2c2d4f439847\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition 8a07e353-9cf6-4f27-8a30-2c2d4f439847</b></p><a name=\"8a07e353-9cf6-4f27-8a30-2c2d4f439847\"> </a><a name=\"hc8a07e353-9cf6-4f27-8a30-2c2d4f439847\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ectd-composition-32p55.html\">eCTD Product Characterisation of Impurities</a></p></div><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.p.5.5}\">m3.2.p.5.5 characterisation of impurities</span></p><p><b>date</b>: 2024-04-24 01:12:07+0000</p><p><b>author</b>: <a href=\"Bundle-CharacterisationImpuritiesProductBundle.html#urn-uuid-98effc99-db2b-428d-89aa-0ce426e02788\">Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000</a></p><p><b>title</b>: Product Characterisation of Impurities</p></div>"
},
"status": "final",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/ICHContextOfUse",
"code": "ich_3.2.p.5.5",
"display": "m3.2.p.5.5 characterisation of impurities"
}
]
},
"date": "2024-04-24T01:12:07.108Z",
"author": [
{
"reference": "urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788"
}
],
"title": "Product Characterisation of Impurities",
"section": [
{
"title": "Impurities for TabletCoatedBeadsCoatedAll",
"code": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/ICHContextOfUse",
"code": "ich_3.2.p.5.5",
"display": "m3.2.p.5.5 characterisation of impurities"
}
]
},
"entry": [
{
"reference": "urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502"
}
]
}
]
}
},
{
"fullUrl": "urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502",
"resource": {
"resourceType": "MedicinalProductDefinition",
"id": "ddd3abad-347c-4d2f-95f3-dd804e250502",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_ddd3abad-347c-4d2f-95f3-dd804e250502\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition ddd3abad-347c-4d2f-95f3-dd804e250502</b></p><a name=\"ddd3abad-347c-4d2f-95f3-dd804e250502\"> </a><a name=\"hcddd3abad-347c-4d2f-95f3-dd804e250502\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-drug-product-with-impurities.html\">Drug Product Impurities</a></p></div><p><b>identifier</b>: TabletCoatedBeadsCoatedAll</p><p><b>description</b>: </p><div><p>A drug product composed of one type of bead with two coatings inside a coated tablet</p>\n</div><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42964}\">TABLET, MULTILAYER</span></p><p><b>route</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38288}\">ORAL</span></p><h3>Impurities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-CharacterisationImpuritiesProductBundle.html#urn-uuid-58ae52aa-c81e-415a-8791-e67a3195290d\">Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000</a></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-CharacterisationImpuritiesProductBundle.html#urn-uuid-ffa30c0b-8031-436a-87f1-635b3bbe5989\">Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000</a></td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: LEVOTHYROXINE SODIUM ANHYDROUS 125mg</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C96971}\">Non-Proprietary</span></p><blockquote><p><b>part</b></p><p><b>part</b>: LEVOTHYROXINE SODIUM ANHYDROUS</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}\">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 125mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">LEVOTHYROXINE SODIUM ANHYDROUS</span></p></blockquote></blockquote></div>"
},
"identifier": [
{
"value": "TabletCoatedBeadsCoatedAll"
}
],
"description": "A drug product composed of one type of bead with two coatings inside a coated tablet",
"combinedPharmaceuticalDoseForm": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C42964",
"display": "TABLET, MULTILAYER"
}
]
},
"route": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C38288",
"display": "ORAL"
}
]
}
],
"impurity": [
{
"reference": {
"reference": "urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d"
}
},
{
"reference": {
"reference": "urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989"
}
}
],
"name": [
{
"productName": "LEVOTHYROXINE SODIUM ANHYDROUS 125mg",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C96971",
"display": "Nonproprietary Name"
}
],
"text": "Non-Proprietary"
},
"part": [
{
"part": "LEVOTHYROXINE SODIUM ANHYDROUS",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code": "SCI"
}
]
}
},
{
"part": "125mg",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code": "STR"
}
],
"text": "LEVOTHYROXINE SODIUM ANHYDROUS"
}
}
]
}
]
}
},
{
"fullUrl": "urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788",
"resource": {
"resourceType": "Organization",
"id": "98effc99-db2b-428d-89aa-0ce426e02788",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_98effc99-db2b-428d-89aa-0ce426e02788\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 98effc99-db2b-428d-89aa-0ce426e02788</b></p><a name=\"98effc99-db2b-428d-89aa-0ce426e02788\"> </a><a name=\"hc98effc99-db2b-428d-89aa-0ce426e02788\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: connectathon_Site</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>connectathon_Site, Restful Rd, Danbury, CT, USA</td></tr></table></div>"
},
"identifier": [
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134003",
"display": "DUNS"
}
]
},
"system": "urn:oid:1.3.6.1.4.1.519.1",
"value": "143265222"
}
],
"name": "connectathon_Site",
"contact": [
{
"address": {
"type": "postal",
"text": "connectathon_Site, Restful Rd, Danbury, CT, USA",
"line": [
"Restful Rd"
],
"city": "Danbury",
"state": "CT",
"postalCode": "06811",
"country": "USA"
}
}
]
}
},
{
"fullUrl": "urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "58ae52aa-c81e-415a-8791-e67a3195290d",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_58ae52aa-c81e-415a-8791-e67a3195290d\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 58ae52aa-c81e-415a-8791-e67a3195290d</b></p><a name=\"58ae52aa-c81e-415a-8791-e67a3195290d\"> </a><a name=\"hc58ae52aa-c81e-415a-8791-e67a3195290d\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity.html\">Drug Substance Impurity</a></p></div><p><b>identifier</b>: DCM</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176815}\">Residual Solvent</span></p><blockquote><p><b>structure</b></p><p><b>technique</b>: <span title=\"Codes:\">Leftover Solvent</span></p><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</span></p><p><b>representation</b>: YMWUJEATGCHHMB-UHFFFAOYSA-N</p><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54683}\">InChI File (small molecule)</span></p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</span></p><p><b>representation</b>: ClCCl</p><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54684}\">SMILES</span></p></blockquote></blockquote><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov 588X2YUY0A}\">588X2YUY0A</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>DICHLOROMETHANE</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C97054}\">Generic Name</span></td><td>true</td></tr></table></div>"
},
"identifier": [
{
"value": "DCM"
}
],
"classification": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C176815",
"display": "Residual Solvent"
}
]
}
],
"structure": {
"technique": [
{
"text": "Leftover Solvent"
}
],
"representation": [
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C45253"
}
]
},
"representation": "YMWUJEATGCHHMB-UHFFFAOYSA-N",
"format": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C54683",
"display": "InChI File (small molecule)"
}
]
}
},
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C45253"
}
]
},
"representation": "ClCCl",
"format": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C54684",
"display": "SMILES"
}
]
}
}
]
},
"code": [
{
"code": {
"coding": [
{
"system": "http://fdasis.nlm.nih.gov",
"code": "588X2YUY0A"
}
]
}
}
],
"name": [
{
"name": "DICHLOROMETHANE",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C97054",
"display": "Generic Name"
}
]
},
"preferred": true
}
]
}
},
{
"fullUrl": "urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "ffa30c0b-8031-436a-87f1-635b3bbe5989",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_ffa30c0b-8031-436a-87f1-635b3bbe5989\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition ffa30c0b-8031-436a-87f1-635b3bbe5989</b></p><a name=\"ffa30c0b-8031-436a-87f1-635b3bbe5989\"> </a><a name=\"hcffa30c0b-8031-436a-87f1-635b3bbe5989\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity.html\">Drug Substance Impurity</a></p></div><p><b>identifier</b>: hydroxyApatite</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176816}\">Degradation Product</span></p><blockquote><p><b>structure</b></p><p><b>technique</b>: <span title=\"Codes:\">formed from dicalcium phosphate degradation</span></p><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</span></p><p><b>representation</b>: XZFUZCHOJLQYHV-UHFFFAOYSA-M</p><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54683}\">InChI File (small molecule)</span></p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}\">String</span></p><p><b>representation</b>: [OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O</p><p><b>format</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54684}\">SMILES</span></p></blockquote></blockquote><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov 91D9GV0Z28}\">91D9GV0Z28</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>TRIBASIC CALCIUM PHOSPHATE</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table></div>"
},
"identifier": [
{
"value": "hydroxyApatite"
}
],
"classification": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C176816",
"display": "Degradation Product"
}
]
}
],
"structure": {
"technique": [
{
"text": "formed from dicalcium phosphate degradation"
}
],
"representation": [
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C45253"
}
]
},
"representation": "XZFUZCHOJLQYHV-UHFFFAOYSA-M",
"format": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C54683",
"display": "InChI File (small molecule)"
}
]
}
},
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C45253"
}
]
},
"representation": "[OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O",
"format": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C54684",
"display": "SMILES"
}
]
}
}
]
},
"code": [
{
"code": {
"coding": [
{
"system": "http://fdasis.nlm.nih.gov",
"code": "91D9GV0Z28"
}
]
}
}
],
"name": [
{
"name": "TRIBASIC CALCIUM PHOSPHATE",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203355",
"display": "GSRS Preferred Term"
}
]
},
"preferred": true
}
]
}
}
]
}