Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 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: 3.2.P.5.5 Bundle

Document Details

Profile: CMC eCTD 32P55 Document

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

Document Content

## Impurities for TabletCoatedBeadsCoatedAll

## Additional Resources Included in Document

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

Resource MedicinalProductDefinition:

> Profile: Drug Product Impurities

> 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:

> Profile: Basic 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:

> Profile: Drug Substance Impurity

> 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:

> Profile: Drug Substance Impurity

> 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