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 1.1.6 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
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Resource Composition:
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identifier: Substance General - levoThyroxine
status: Final
type: Substance General Information
date: 2023-12-15 22:19:47+0000
title: eCTD Substance General Information for levoThyroxine
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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: Structure
representation: YDTFRJLNMPSCFM-YDALLXLXSA-M
representation
type: Structure
representation: [Na+].N[C@@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O
representation
type: Graphics
representation
type: 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
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Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition 832f22b4-6f0c-41f8-9b7d-f26f55e9973c
identifier: DextroThyroxine
structure
molecularFormula: C15H10I4NO4.Na.H2O
representation
type: Structure
representation: ANMYAHDLKVNJJO-CURYUGHLSA-M
representation
type: Structure
representation: O.[Na+].N[C@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O
representation
type: Graphics
Codes
Code 0H00N2AHSP Names
Name Type Preferred DEXTROTHYROXINE SODIUM GSRS Preferred Term true
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Resource Organization:
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identifier: DUNS/143265222
name: Vandechemie
Contacts
Address Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium
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Resource Organization:
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identifier: DUNS/143265222, FEI/6981397
name: East-West Manufacturing
Contacts
Address East-West Manufacturing, 100 Stillwater Avenue, Building #2, Bangor, ME, United States
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Resource DocumentReference:
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status: Current
content
Attachments
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Resource DocumentReference:
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status: Current
content
Attachments
ContentType Data Title image/png (base64 data - 4,372 base64 chars) Levothyroid.png
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Resource DocumentReference:
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status: Current
content
Attachments
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