Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
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
Document Details
Generated Narrative: Bundle eCTD Product Characterisation of Impurities Composition for TabletCoatedBeadsCoatedAll
Document Content
Entry 1 - fullUrl = urn:uuid:8a07e353-9cf6-4f27-8a30-2c2d4f439847
Resource Composition:
Generated Narrative: Composition 8a07e353-9cf6-4f27-8a30-2c2d4f439847
status: Final
type: Product Characterisation of Impurities
date: 2024-04-24 01:12:07+0000
title: eCTD Product Characterisation of Impurities Composition for TabletCoatedBeadsCoatedAll
Entry 2 - fullUrl = urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition ddd3abad-347c-4d2f-95f3-dd804e250502
identifier: TabletCoatedBeadsCoatedAll
description:
A drug product composed of one type of bead with two coatings inside a coated tablet
combinedPharmaceuticalDoseForm: TABLET, MULTILAYER
route: ORAL
Impurities
name
productName: LEVOTHYROXINE SODIUM ANHYDROUS 125mg
type: Non-Proprietary
part
part: LEVOTHYROXINE SODIUM ANHYDROUS
type: scientific name
part
part: 125mg
type: LEVOTHYROXINE SODIUM ANHYDROUS
Entry 3 - fullUrl = urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788
Resource Organization:
Generated Narrative: Organization 98effc99-db2b-428d-89aa-0ce426e02788
identifier: DUNS/143265222
name: connectathon_Site
Contacts
Address connectathon_Site, Restful Rd, Danbury, CT, USA
Entry 4 - fullUrl = urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition 58ae52aa-c81e-415a-8791-e67a3195290d
identifier: DCM
classification: Residual Solvent
structure
technique: Leftover Solvent
representation
type: String
representation: YMWUJEATGCHHMB-UHFFFAOYSA-N
format: InChI File (small molecule)
representation
type: String
representation: ClCCl
format: SMILES
Codes
Code 588X2YUY0A Names
Name Type Preferred DICHLOROMETHANE Generic Name true
Entry 5 - fullUrl = urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition ffa30c0b-8031-436a-87f1-635b3bbe5989
identifier: hydroxyApatite
classification: Degradation Product
structure
technique: formed from dicalcium phosphate degradation
representation
type: String
representation: XZFUZCHOJLQYHV-UHFFFAOYSA-M
format: InChI File (small molecule)
representation
type: String
representation: [OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O
format: SMILES
Codes
Code 91D9GV0Z28 Names
Name Type Preferred TRIBASIC CALCIUM PHOSPHATE GSRS Preferred Term true
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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