N Nitroso Bisoprolol EP Impurity A
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  • New Jersey, USA
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  • Mumbai, India

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Documentation

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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

N Nitroso Bisoprolol EP Impurity A

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Catalogue No.:VE0017358
CAS No.:N/A
Mol. Formula:C13H20N2O4
Mol. Weight:268.3 g/mol

Additional information on N Nitroso Bisoprolol EP Impurity A

Parent drug

Bisoprolol

IUPAC Name

N-(2-Hydroxy-3-(4-(hydroxymethyl)phenoxy)propyl)-N-isopropylnitrous amide

Synonyms

N/A

Smiles

O=NN(CC(O)COC1=CC=C(CO)C=C1)C(C)C

InChI

InChI=1S/C13H20N2O4/c1-10(2)15(14-18)7-12(17)9-19-13-5-3-11(8-16)4-6-13/h3-6,10,12,16-17H,7-9H2,1-2H3

Description

N Nitroso Bisoprolol EP Impurity A is an N-nitroso derivative of the secondary amine present in Bisoprolol | 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 Bisoprolol 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.

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