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1. Comparison of Approaches to Determining N-Nitrosodimethylamine Impurity in Valsartan Drug Substance By GC-MS Methods

Author

M. D. Khorol’skii, N. V. Maslennikova, O. V. Anan’ina, A. A. Chaplenko, Galina V. Ramenskaya, and I. V. Nedkov

Subjects
Pharmacology, Drug, Chromatography, 010405 organic chemistry, Chemistry, media_common.quotation_subject, Pharmacology toxicology, 01 natural sciences, 0104 chemical sciences, 010404 medicinal & biomolecular chemistry, chemistry.chemical_compound, Valsartan, Impurity, N-Nitrosodimethylamine, Drug Discovery, medicine, Gas chromatography, Gas chromatography–mass spectrometry, medicine.drug, media_common
Abstract

Methods for determining the genotoxic impurity N-nitrosodimethylamine (NDMA) in valsartan drug substance by gas chromatography (GC) with mass-spectrometric detection in SIM and MRM modes using direct introduction and vapor-phase analysis are compared. The obtained LOQ and DL differed insignificantly. The test results led to the conclusion that use of a method corresponding to the capabilities and equipment of the laboratory was advisable.

Published
2019

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