Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
Generated Narrative: Composition
Resource Composition "260f5aa3-23d2-4999-8e5f-70f247390ee5"
Profile: eCTD Substance General Information
identifier: Substance General - levoThyroxine
status: FINAL
type: Substance General Information (Code System PQCMC Comp Section Types#32S10)
date: 2023-12-15 22:19:47+0000
author: See on this page: urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7
title: eCTD Substance General Information for levoThyroxine
2. urn:uuid:21b6b724-507e-4cf4-a462-93334b98d166 (SubstanceDefinition/21b6b724-507e-4cf4-a462-93334b98d166)
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "21b6b724-507e-4cf4-a462-93334b98d166"
Profile: Substance General Information
identifier: levoThyroxine
classification: Chemical (PQ-CMC-FDA Temporary Codes#C48807)
manufacturer: See on this page: urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501
supplier: See on this page: urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b
MolecularWeights
Amount 798.85 u (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C41127 = 'u') structure
technique: NMR Spectroscopy ()
representation
type: InChI File (small molecule) (PQ-CMC-FDA Temporary Codes#C54683)
representation: YDTFRJLNMPSCFM-YDALLXLXSA-M
representation
type: SMILES (PQ-CMC-FDA Temporary Codes#C54684)
representation: [Na+].N[C@@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O
representation
document: See on this page: urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7
representation
document: See on this page: urn:uuid:22bd989e-8056-494f-9bc1-195d13428179
Codes
Code 054I36CPMN (Unique Ingredient Identifier (UNII)#054I36CPMN) name
name: LEVOTHYROXINE SODIUM ANHYDROUS
type: GSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)
preferred: true
name
name: sodium;(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate
type: IUPAC Name (PQ-CMC-FDA Temporary Codes#C203356)
name
name: 55-03-8
type: CAS Number (PQ-CMC-FDA Temporary Codes#C54682)
Relationships
SubstanceDefinition[x] Type See on this page: urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973c Polymorph ()
3. urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973c (SubstanceDefinition/832f22b4-6f0c-41f8-9b7d-f26f55e9973c)
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "832f22b4-6f0c-41f8-9b7d-f26f55e9973c"
Profile: Polymorphic Form
identifier: DextroThyroxine
structure
molecularFormula: C15H10I4NO4.Na.H2O
representation
type: InChI File (small molecule) (PQ-CMC-FDA Temporary Codes#C54683)
representation: ANMYAHDLKVNJJO-CURYUGHLSA-M
representation
type: SMILES (PQ-CMC-FDA Temporary Codes#C54684)
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
document: See on this page: urn:uuid:0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3
Codes
Code 0H00N2AHSP (Unique Ingredient Identifier (UNII)#0H00N2AHSP) Names
Name Type Preferred DEXTROTHYROXINE SODIUM GSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355) true
4. urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7 (Organization/b69435a0-45c6-4d44-9fde-b354e17408d7)
Generated Narrative: Organization
Resource Organization "b69435a0-45c6-4d44-9fde-b354e17408d7"
Profile: Sponsor Organization
identifier: DUNS/143265222
name: Large Life
Contacts
Address 123 Broad Way, New York, NY, United States
5. urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b (Organization/e165f057-5eed-4e64-8328-4438fc88fb1b)
Generated Narrative: Organization
Resource Organization "e165f057-5eed-4e64-8328-4438fc88fb1b"
Profile: Supplier Organization
identifier: DUNS/143265222
name: Vandechemie
Contacts
Address Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium
6. urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501 (Organization/e875ef93-a730-4c44-bead-53663ae7f501)
Generated Narrative: Organization
Resource 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
7. urn:uuid:0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3 (DocumentReference/0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3)
Generated Narrative: DocumentReference
Resource DocumentReference "0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3"
Profile: Document Reference Attachment
status: CURRENT
content
Attachments
ContentType Data Title image/png (base64 data - 3350 bytes) Monosodium_D-thyroxine_hydrate.png
8. urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7 (DocumentReference/d94ad7ac-b935-432f-bc68-312b6b8dcca7)
Generated Narrative: DocumentReference
Resource DocumentReference "d94ad7ac-b935-432f-bc68-312b6b8dcca7"
Profile: Document Reference Attachment
status: CURRENT
content
Attachments
ContentType Data Title image/png (base64 data - 3277 bytes) Levothyroid.png
9. urn:uuid:22bd989e-8056-494f-9bc1-195d13428179 (DocumentReference/22bd989e-8056-494f-9bc1-195d13428179)
Generated Narrative: DocumentReference
Resource DocumentReference "22bd989e-8056-494f-9bc1-195d13428179"
Profile: Document Reference Attachment
status: CURRENT
content
Attachments
ContentType Data Title application/octet-stream (base64 data - 2574 bytes) L-thyroxine-3D-structure-CT1000583834.sdf
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-08
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