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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 Telmisartan EP Impurity A

● Under Development

Catalogue No.:	VE0012689
CAS No.:	N/A
Mol. Formula:	C19H19N5O
Mol. Weight:	333.39 g/mol

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Additional information on N-Nitroso Telmisartan EP Impurity A

Parent drug

Telmisartan

IUPAC Name

1, 7′-Dimethyl-3′-nitroso-2′- propyl-1H, 3’H-2, 5′- bibenzo[d]imidazole

Pharmacopoeial Synonyms

N/A

Other Synonyms

N-Nitroso Telmisartan Related Compound A

Smiles

CCCC1=NC2=C(C)C=C(C3=NC4=CC=CC=C4N3C)C=C2N1N=O

InChI

InChI=1S/C19H19N5O/c1-4-7-17-21-18-12(2)10-13(11-16(18)24(17)22-25)19-20-14-8-5-6-9-15(14)23(19)3/h5-6,8-11H,4,7H2,1-3H3

Description

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