Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2 United States of America flag

This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v2.0.0: STU2) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

Example Bundle: 3.2.P.5.5 Bundle



Document Content

Impurities for TabletCoatedBeadsCoatedAll


Additional Resources Included in Document


Entry 2 - fullUrl = urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502

Resource MedicinalProductDefinition:

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

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


Entry 3 - fullUrl = urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788

Resource Organization:

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:

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

-NameTypePreferred
*DICHLOROMETHANEGeneric Nametrue

Entry 5 - fullUrl = urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989

Resource SubstanceDefinition:

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

-NameTypePreferred
*TRIBASIC CALCIUM PHOSPHATEGSRS Preferred Termtrue