Generated Narrative: Composition 45ec3ebc-ec1a-4b4d-bfc4-c50edc67f2ce Profile: eCTD Product Characterisation of Impurities status: Final type: m3.2.p.5.5 characterisation of impurities date: 2024-07-16 10:15:00+0000 author: Bundle: identifier = UUID:a7a2d35b-5d9d-4a8c-b012-d04a07662c0a; type = document; timestamp = 2024-07-16 10:15:00+0000 title: Product Characterisation of Impurities
m3.2.p.5.5 characterisation of impurities
Substance Impurities for AmphetamineSalt_1
Generated Narrative: MedicinalProductDefinition 6248d2ea-c9e0-4280-9beb-08b7041071c2 Profile: Drug Product Impurities identifier: AmphetamineSalt_1 description: An uncoated tablet containing amphetamine sulfate combinedPharmaceuticalDoseForm: TABLET route: ORAL Impurities - Reference * Bundle: identifier = UUID:a7a2d35b-5d9d-4a8c-b012-d04a07662c0a; type = document; timestamp = 2024-07-16 10:15:00+0000 * Bundle: identifier = UUID:a7a2d35b-5d9d-4a8c-b012-d04a07662c0a; type = document; timestamp = 2024-07-16 10:15:00+0000 * Bundle: identifier = UUID:a7a2d35b-5d9d-4a8c-b012-d04a07662c0a; type = document; timestamp = 2024-07-16 10:15:00+0000 name productName: AMPHETAMINE SULFATE 10mg, DEXTROAMPHETAMINE SULFATE 10mg type: Nonproprietary Name 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
An uncoated tablet containing amphetamine sulfate
AMPHETAMINE SULFATE 10mg, DEXTROAMPHETAMINE SULFATE 10mg
Generated Narrative: Organization f22ab70c-20c0-4ee4-848b-622b67ec8592 Profile: Basic Organization identifier: DUNS/143265222 name: WunderChem GmbH Contacts - Address * 123 Deutsche Strasse, Munich, Bavaria, 81541, Germany
123 Deutsche Strasse, Munich, Bavaria, 81541, Germany
Generated Narrative: SubstanceDefinition ac7ac2da-df69-4ed9-b399-4dc40a71b332 Profile: Drug Substance Impurity 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: String representation: InChI=1S/C9H10O/c1-8(10)7-9-5-3-2-4-6-9/h2-6H,7H2,1H3 format: InChI File (small molecule) representation type: String representation: CC(=O)CC1=CC=CC=C1 format: SMILES representation type: CHEMICAL STRUCTURE format: SDF document: Bundle: identifier = UUID:a7a2d35b-5d9d-4a8c-b012-d04a07662c0a; type = document; timestamp = 2024-07-16 10:15:00+0000 Codes - Code * O7IZH10V9Y Names - Name Type Preferred * PHENYL ACETONE GSRS Preferred Term true
Generated Narrative: DocumentReference de75e338-626c-4503-a25d-4fcdd8e39bee Profiles: Structure Data Reference, Document Reference Attachment status: Current content Attachments - ContentType Data Title * application/x-mdl-sdfile (base64 data - 2,556 base64 chars) phenylAcetone.sdf
Generated Narrative: SubstanceDefinition 7f7c63b0-8ad8-4529-b000-bf4b6c384558 Profile: Drug Substance Impurity 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 [binary] 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: String representation: InChI=1S/CH5N/c1-2/h2H2,1H3 format: InChI File (small molecule) representation type: String representation: CN format: SMILES Codes - Code * BSF23SJ79E Names - Name Type Preferred * METHYLAMINE GSRS Preferred Term true
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 |
Generated Narrative: SubstanceDefinition 8202d18a-df68-4cbd-912d-59c7cff5cfa6 Profile: Drug Substance Impurity identifier: ironImpurity classification: Elemental Impurities structure technique: UV Spectroscopy Representations - Type Representation Format * String [Fe] SMILES Codes - Code * E1UOL152H7 Names - Name Type Preferred * IRON GSRS Preferred Term true