Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon
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
Entry 1 - fullUrl = urn:uuid:45ec3ebc-ec1a-4b4d-bfc4-c50edc67f2ce
Resource Composition:
Generated Narrative: Composition 45ec3ebc-ec1a-4b4d-bfc4-c50edc67f2ce
status: Final
type: Product Characterisation of Impurities
date: 2024-07-16 10:15:00+0000
title: eCTD Product Characterisation of Impurities
Entry 2 - fullUrl = urn:uuid:6248d2ea-c9e0-4280-9beb-08b7041071c2
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition 6248d2ea-c9e0-4280-9beb-08b7041071c2
identifier: AmphetamineSalt_1
description:
An uncoated tablet containing amphetamine sulfate
combinedPharmaceuticalDoseForm: TABLET
route: ORAL
Impurities
name
productName: AMPHETAMINE SULFATE 10mg, DEXTROAMPHETAMINE SULFATE 10mg
type: Non-Proprietary
part
part: AMPHETAMINE SULFATE
type: scientific name
part
part: 10mg
type: AMPHETAMINE SULFATE
part
part: DEXTROAMPHETAMINE SULFATE
type: scientific name
part
part: 10mg
type: DEXTROAMPHETAMINE SULFATE
Entry 3 - fullUrl = urn:uuid:f22ab70c-20c0-4ee4-848b-622b67ec8592
Resource Organization:
Generated Narrative: Organization f22ab70c-20c0-4ee4-848b-622b67ec8592
identifier: DUNS/143265222
name: WunderChem GmbH
Contacts
Address 123 Deutsche Strasse, Munich, Bavaria, 81541, Germany
Entry 4 - fullUrl = urn:uuid:ac7ac2da-df69-4ed9-b399-4dc40a71b332
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition ac7ac2da-df69-4ed9-b399-4dc40a71b332
identifier: PhenylAcetone
classification: Process Related/Process
characterization
technique: IR Spectroscopy
Files
ContentType Data Title application/x-jcamp-dx (base64 data - 5,896 base64 chars) PhenylAcetone-IR.jdx characterization
technique: Proton NMR and Carbon NMR
description:
A phenylacetone sample was analyzed using HNMR and CNMR spectroscopy. The assignments of the protons and carbons are detailed in the tables below.
Table 1: HNMR Assignments for Phenylacetone
Hydrogen No. Delta (ppm) Multiplicity No. of Protons Coupling (Hz) H1 7.251 tt 1 7.71, 1.53 H2,H3 7.305 tdd 2 7.74 1.82 0.55 H4,H5 7.11 dddd 2 7.77 1.53 1.20 0.55 H6,H7 3.589 s 2 -- H8,H9,H10 2.145 s 3 -- Table 2 : CNMR Assignments for Phenylacetone
Carbon No. Delta (ppm) C1 128.10 C2,C6 128.60 C3,C5 128.40 C4 133.70 C7 50.24 C8 205.55 C9 29.9 Files
ContentType Data Title application/x-jcamp-dx (base64 data - 16,200 base64 chars) PhenylAecetone-HNMR.jdx image/svg+xml (base64 data - 199,128 base64 chars) PhenylAcetone-HNMR.svg application/x-jcamp-dx (base64 data - 1,760 base64 chars) PhenylAcetone-CNMR.jdx image/png (base64 data - 69,124 base64 chars) PhenylAcetone-CNMR.png structure
technique: HNMR, IR Spectroscopy
representation
type: Structure
representation: InChI=1S/C9H10O/c1-8(10)7-9-5-3-2-4-6-9/h2-6H,7H2,1H3
representation
type: Structure
representation: CC(=O)CC1=CC=CC=C1
representation
type: Structure
Codes
Code O7IZH10V9Y Names
Name Type Preferred PHENYL ACETONE GSRS Preferred Term true
Entry 5 - fullUrl = urn:uuid:de75e338-626c-4503-a25d-4fcdd8e39bee
Resource DocumentReference:
Generated Narrative: DocumentReference de75e338-626c-4503-a25d-4fcdd8e39bee
status: Current
content
Attachments
ContentType Data Title application/x-mdl-sdfile (base64 data - 2,556 base64 chars) phenylAcetone.sdf
Entry 6 - fullUrl = urn:uuid:7f7c63b0-8ad8-4529-b000-bf4b6c384558
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition 7f7c63b0-8ad8-4529-b000-bf4b6c384558
identifier: MethylAmine
classification: Process Related/Process
characterization
technique: IR Spectroscopy
description:
Table 1: IR spectrum assignments
Wavenumber (cm^-1) Intensity Assignment 2930 s C-H 1615 w N-H 1060 w C-N Files
ContentType Data Title application/x-jcamp-dx (base64 data - 6,488 base64 chars) methylamine-IR.jdx characterization
technique: NMR Spectroscopy
description:
Methylamine was analyzed using proton NMR and Carbon NMR. Assignment data is included in subsequent tables
Table 1: HNMR assignments for Methylamine
Hydrogen No. Delta (ppm) Multiplicity No. of Protons Coupling (Hz) H1,H2,H3 2.231 s 3 -- Table 2: CNMR assignments for Methylamine
Carbon No. Delta (ppm) C1 28.3 Files
ContentType Data Title application/x-jcamp-dx (base64 data - 1,336 base64 chars) methylamine-HNMR.jdx application/x-jcamp-dx 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methylamine-CNMR.jdx image/png (base64 data - 44,416 base64 chars) methylamine-CNMR.png image/png (base64 data - 47,692 base64 chars) methylamine-HNMR.png structure
technique: Carbon NMR
representation
type: Structure
representation: InChI=1S/CH5N/c1-2/h2H2,1H3
representation
type: Structure
representation: CN
Codes
Code BSF23SJ79E Names
Name Type Preferred METHYLAMINE GSRS Preferred Term true
Entry 7 - fullUrl = urn:uuid:8202d18a-df68-4cbd-912d-59c7cff5cfa6
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition 8202d18a-df68-4cbd-912d-59c7cff5cfa6
identifier: ironImpurity
classification: Elemental Impurities
structure
technique: UV Spectroscopy
Representations
Type Representation Structure [Fe] Codes
Code E1UOL152H7 Names
Name Type Preferred IRON GSRS Preferred Term true
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.1.6 based on FHIR 5.0.0. Generated 2024-09-22
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