Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
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-ballot 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
Document Content
Entry 1 - fullUrl = urn:uuid:260f5aa3-23d2-4999-8e5f-70f247390ee5
Resource Composition:
Generated Narrative: Composition 260f5aa3-23d2-4999-8e5f-70f247390ee5
identifier: Substance General - levoThyroxine
status: Final
type: General Information
date: 2023-12-15 22:19:47+0000
title: eCTD Substance General Information for levoThyroxine
Entry 2 - fullUrl = urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7
Resource Organization:
Generated Narrative: Organization b69435a0-45c6-4d44-9fde-b354e17408d7
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:
Generated Narrative: SubstanceDefinition 21b6b724-507e-4cf4-a462-93334b98d166
identifier: levoThyroxine
classification: Chemical
manufacturer: Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+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
representation
type: CHEMICAL STRUCTURE
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:
Generated Narrative: SubstanceDefinition 832f22b4-6f0c-41f8-9b7d-f26f55e9973c
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
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:
Generated Narrative: Organization e165f057-5eed-4e64-8328-4438fc88fb1b
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:
Generated Narrative: Organization e875ef93-a730-4c44-bead-53663ae7f501
identifier: DUNS/143265222, 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:
Generated Narrative: DocumentReference 0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3
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:
Generated Narrative: DocumentReference d94ad7ac-b935-432f-bc68-312b6b8dcca7
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:
Generated Narrative: DocumentReference 22bd989e-8056-494f-9bc1-195d13428179
status: Current
content
Attachments
ContentType Data Title application/x-mdl-sdfile (base64 data - 3,432 base64 chars) L-thyroxine-3D-structure-CT1000583834.sdf
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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