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

摘要

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.