Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon United States of America flag

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

Example Bundle: Bundle for 3.2.S.1

Document Details

Generated Narrative: Bundle eCTD Substance General Information for levoThyroxine


Document Content

Drug Substance Nomeclature and Structure for levoThyroxine


Additional Resources Included in Document


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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

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

title: eCTD Substance General Information for levoThyroxine


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Resource Organization:

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identifier: DUNS/143265222

name: Large Life

Contacts

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

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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

supplier: 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

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

representation

type: 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+0000Polymorph

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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

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

Codes

-Code
*0H00N2AHSP

Names

-NameTypePreferred
*DEXTROTHYROXINE SODIUMGSRS Preferred Termtrue

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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:

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

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Resource DocumentReference:

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status: Current

content

Attachments

-ContentTypeDataTitle
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Resource DocumentReference:

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status: Current

content

Attachments

-ContentTypeDataTitle
*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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