Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon United States of America flag

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 1.1.6 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

Example Bundle: 9e8f2d16-66b1-47ec-878d-f50ae021985b

Document Details

Generated Narrative: Bundle eCTD Product Characterisation of Impurities Composition for TabletCoatedBeadsCoatedAll


Document Content

Impurities for TabletCoatedBeadsCoatedAll


Additional Resources Included in Document


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Resource Composition:

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status: Final

type: Product Characterisation of Impurities

date: 2024-04-24 01:12:07+0000

author: Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000

title: eCTD Product Characterisation of Impurities Composition for TabletCoatedBeadsCoatedAll


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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

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*Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000

name

productName: LEVOTHYROXINE SODIUM ANHYDROUS 125mg

type: Non-Proprietary

part

part: LEVOTHYROXINE SODIUM ANHYDROUS

type: scientific name

part

part: 125mg

type: LEVOTHYROXINE SODIUM ANHYDROUS


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Resource Organization:

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identifier: DUNS/143265222

name: connectathon_Site

Contacts

-Address
*connectathon_Site, Restful Rd, Danbury, CT, USA

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Resource SubstanceDefinition:

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identifier: DCM

classification: Residual Solvent

structure

technique: Leftover Solvent

representation

type: Structure

representation: YMWUJEATGCHHMB-UHFFFAOYSA-N

representation

type: Structure

representation: ClCCl

Codes

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*588X2YUY0A

Names

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*DICHLOROMETHANEGeneric Nametrue

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Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition ffa30c0b-8031-436a-87f1-635b3bbe5989

identifier: hydroxyApatite

classification: Degradation Product

structure

technique: formed from dicalcium phosphate degradation

representation

type: Structure

representation: XZFUZCHOJLQYHV-UHFFFAOYSA-M

representation

type: Structure

representation: [OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O

Codes

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*91D9GV0Z28

Names

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*TRIBASIC CALCIUM PHOSPHATEGSRS Preferred Termtrue