Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.2 - 1.1.2 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 1.1.2 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: 9e8f2d16-66b1-47ec-878d-f50ae021985b

Generated Narrative: Composition

ResourceComposition "8a07e353-9cf6-4f27-8a30-2c2d4f439847"

Profile: eCTD Product Characterisation of Impurities Composition

status: FINAL

type: Product Characterisation of Impurities (Code System PQCMC Comp Section Types#32P55)

date: 2024-04-24 01:12:07+0000

author: See on this page: urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788

title: eCTD Product Characterisation of Impurities Composition for TabletCoatedBeadsCoatedAll

Impurities for TabletCoatedBeadsCoatedAll

Additional Document Content

2. urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502 (MedicinalProductDefinition/ddd3abad-347c-4d2f-95f3-dd804e250502)

Generated Narrative: MedicinalProductDefinition

ResourceMedicinalProductDefinition "ddd3abad-347c-4d2f-95f3-dd804e250502"

Profile: Drug Product Impurities

identifier: TabletCoatedBeadsCoatedAll

description: A drug product composed of one type of bead with two coatings inside a coated tablet

combinedPharmaceuticalDoseForm: TABLET, MULTILAYER (PQ-CMC-FDA Temporary Codes#C42964)

Impurities

-Reference
*See on this page: urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d
*See on this page: urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989

name

productName: LEVOTHYROXINE SODIUM ANHYDROUS 125mg

type: Non-Proprietary (Product Name Types Code Types#NON)

part

part: LEVOTHYROXINE SODIUM ANHYDROUS

type: scientific name (EntityNamePartQualifierR2#SCI)

part

part: 125mg

type: LEVOTHYROXINE SODIUM ANHYDROUS (EntityNamePartQualifierR2#STR)

3. urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788 (Organization/98effc99-db2b-428d-89aa-0ce426e02788)

Generated Narrative: Organization

ResourceOrganization "98effc99-db2b-428d-89aa-0ce426e02788"

Profile: Sponsor Organization

identifier: DUNS/143265222

name: connectathon_Site

Contacts

-Address
*connectathon_Site, Restful Rd, Danbury, CT, USA

4. urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d (SubstanceDefinition/58ae52aa-c81e-415a-8791-e67a3195290d)

Generated Narrative: SubstanceDefinition

ResourceSubstanceDefinition "58ae52aa-c81e-415a-8791-e67a3195290d"

Profile: Drug Substance Impurity

identifier: DCM

classification: Residual Solvent (PQ-CMC-FDA Temporary Codes#C176815)

structure

technique: Leftover Solvent ()

representation

type: InChI File (small molecule) (PQ-CMC-FDA Temporary Codes#C54683)

representation: YMWUJEATGCHHMB-UHFFFAOYSA-N

representation

type: SMILES (PQ-CMC-FDA Temporary Codes#C54684)

representation: ClCCl

Codes

-Code
*588X2YUY0A (Unique Ingredient Identifier (UNII)#588X2YUY0A)

Names

-NameTypePreferred
*DICHLOROMETHANEGeneric Name (PQ-CMC-FDA Temporary Codes#C97054)true

5. urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989 (SubstanceDefinition/ffa30c0b-8031-436a-87f1-635b3bbe5989)

Generated Narrative: SubstanceDefinition

ResourceSubstanceDefinition "ffa30c0b-8031-436a-87f1-635b3bbe5989"

Profile: Drug Substance Impurity

identifier: hydroxyApatite

classification: Degradation Product (PQ-CMC-FDA Temporary Codes#C176816)

structure

technique: formed from dicalcium phosphate degradation ()

representation

type: InChI File (small molecule) (PQ-CMC-FDA Temporary Codes#C54683)

representation: XZFUZCHOJLQYHV-UHFFFAOYSA-M

representation

type: SMILES (PQ-CMC-FDA Temporary Codes#C54684)

representation: [OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O

Codes

-Code
*91D9GV0Z28 (Unique Ingredient Identifier (UNII)#91D9GV0Z28)

Names

-NameTypePreferred
*TRIBASIC CALCIUM PHOSPHATEGSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)true