Additional Resources Included in Document

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

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

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

-	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:

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