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
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
| Code |
| BSF23SJ79E |
| Name | Type | Preferred |
| METHYLAMINE | 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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