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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,N-Dinitroso Salbutamol EP Impurity F

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Nº do catálogo:	VE0024936
Nº CAS:	N/A
Fórmula Mol.::	C26H38N4O7
Peso Mol.::	518.61 g/mol

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Informações adicionais sobre o N | N-Dinitroso Salbutamol EP Impurity F

Fármaco de origem

Salbutamol

Nome IUPAC

N, N’-(((oxybis(methylene))bis(4-hydroxy-3, 1-phenylene))bis(2-hydroxyethane-2, 1-diyl))bis(N-(tert-butyl)nitrous amide)

Sinônimos farmacopeicos

N/A

Outros sinônimos

N/A

SMILES

OC1=CC=C(C(O)CN(C(C)(C)C)N=O)C=C1COCC2=CC(C(O)CN(C(C)(C)C)N=O)=CC=C2O

InChI

InChI=1S/C26H38N4O7/c1-25(2, 3)29(27-35)13-23(33)17-7-9-21(31)19(11-17)15-37-16-20-12-18(8-10-22(20)32)24(34)14-30(28-36)26(4, 5)6/h7-12, 23-24, 31-34H, 13-16H2, 1-6H3

Descrição

N | N-Dinitroso Salbutamol EP Impurity F is an N-nitroso derivative of the secondary amine present in Salbutamol | 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 Salbutamol 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.