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Inclui: HPLC, MASS/LC-MS, RMN de 1H, FT-IR, teor, Relatório de Elucidação Estrutural (SER) e dados analíticos adicionais dependendo do produto.

N-Nitroso Amoxicillin EP Impurity C

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Nº do catálogo:	VE0024322
Nº CAS:	N/A
Fórmula Mol.::	C16H18N4O6S
Peso Mol.::	394.40 g/mol

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Informações adicionais sobre o N-Nitroso Amoxicillin EP Impurity C

Fármaco de origem

Amoxicillin

Nome IUPAC

(4S)-2-(5-(4-hydroxyphenyl)-3, 6-dioxopiperazin-2-yl)-5, 5-dimethyl-3-nitrosothiazolidine-4-carboxylic acid

Sinônimos farmacopeicos

N/A

Outros sinônimos

N/A

SMILES

O=C(NC1C2N(N=O)[C@@]([H])(C(O)=O)C(C)(C)S2)C(C3=CC=C(O)C=C3)NC1=O

InChI

InChI=1S/C16H18N4O6S/c1-16(2)11(15(24)25)20(19-26)14(27-16)10-13(23)17-9(12(22)18-10)7-3-5-8(21)6-4-7/h3-6, 9-11, 14, 21H, 1-2H3, (H, 17, 23)(H, 18, 22)(H, 24, 25)

Descrição

N-Nitroso Amoxicillin EP Impurity C is an N-nitroso derivative of the secondary amine present in Amoxicillin | which is a highly characterized reference material that meets stringent regulatory standards set for nitrosamine compounds | including those set by USP | EMA | JP | and BP. This nitroso standard is essential for a variety of applications | such as analytical method development | method validation (AMV) | and Quality Control (QC) | particularly in the context of Amoxicillin production. It is suitable for use in both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA). This nitrosamine standard helps establish detection limits | quantify impurity levels | and ensure trace nitroso impurities in pharmaceutical products remain within FDA and EMA safety limits.