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.S.1 Bundle

Document Details

Profile: CMC eCTD 32S10 Document

Final Document at 2023-12-15 22:19:47+0000 by Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 for

Document Content

## Drug Substance Nomeclature and Structure for levoThyroxine

## Additional Resources Included in Document

Entry 2 - fullUrl = urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7

Resource Organization:

> Profile: Basic Organization

> identifier: DUNS/143265222

> name: Large Life

> ### Contacts

> - | Address
> * | 123 Broad Way, New York, NY, United States

Entry 3 - fullUrl = urn:uuid:21b6b724-507e-4cf4-a462-93334b98d166

Resource SubstanceDefinition:

> Profile: Substance General Information

> identifier: levoThyroxine

> classification: Chemical

> manufacturer: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> supplier: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> ### MolecularWeights

> - | Amount
> * | 798.85 unified atomic mass unit (Details: UCUM codeu = 'u')

> > structure

> > technique: NMR Spectroscopy

> > > representation

> > > type: String

> > > representation: YDTFRJLNMPSCFM-YDALLXLXSA-M

> > > format: InChI File (small molecule)

> > > representation

> > > type: String

> > > representation: [Na+].N[C@@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O

> > > format: SMILES

> > > representation

> > > type: Picture

> > > document: Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000

> > > representation

> > > type: CHEMICAL STRUCTURE

> > > document: Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000

> ### Codes

> - | Code
> * | 054I36CPMN

> > name

> > name: LEVOTHYROXINE SODIUM ANHYDROUS

> > type: GSRS Preferred Term

> > preferred: true

> > name

> > name: sodium;(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate

> > type: IUPAC Name

> > name

> > name: 55-03-8

> > type: CAS Number

> ### Relationships

> - | SubstanceDefinition[x] | Type
> * | Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000 | Polymorph

Entry 4 - fullUrl = urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973c

Resource SubstanceDefinition:

> Profile: Polymorphic Form

> identifier: DextroThyroxine

> > structure

> > molecularFormula: C15H10I4NO4.Na.H2O

> > > representation

> > > type: String

> > > representation: ANMYAHDLKVNJJO-CURYUGHLSA-M

> > > format: InChI File (small molecule)

> > > representation

> > > type: String

> > > representation: O.[Na+].N[C@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O

> > > format: SMILES

> > > representation

> > > type: Picture

> > > document: Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000

> ### Codes

> - | Code
> * | 0H00N2AHSP

> ### Names

> - | Name | Type | Preferred
> * | DEXTROTHYROXINE SODIUM | GSRS Preferred Term | true

Entry 5 - fullUrl = urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b

Resource Organization:

> Profile: Basic Organization

> identifier: DUNS/143265222

> name: Vandechemie

> ### Contacts

> - | Address
> * | Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium

Entry 6 - fullUrl = urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501

Resource Organization:

> Profile: Basic Organization

> identifier: DUNS/147275722, FEI/6981397

> name: East-West Manufacturing

> ### Contacts

> - | Address
> * | East-West Manufacturing, 100 Stillwater Avenue, Building #2, Bangor, ME, United States

Entry 7 - fullUrl = urn:uuid:0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3

Resource DocumentReference:

> Profile: Graphic Reference

> status: Current

> > content

> > ### Attachments

> > - | ContentType | Data | Title
> > * | image/png | (base64 data - 4,468 base64 chars) | Monosodium_D-thyroxine_hydrate.png

Entry 8 - fullUrl = urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7

Resource DocumentReference:

> Profile: Graphic Reference

> status: Current

> > content

> > ### Attachments

> > - | ContentType | Data | Title
> > * | image/png | (base64 data - 4,372 base64 chars) | Levothyroid.png

Entry 9 - fullUrl = urn:uuid:22bd989e-8056-494f-9bc1-195d13428179

Resource DocumentReference:

> Profile: Structure Data Reference

> status: Current

> > content

> > ### Attachments

> > - | ContentType | Data | Title
> > * | application/x-mdl-sdfile | (base64 data - 3,432 base64 chars) | L-thyroxine-3D-structure-CT1000583834.sdf