DefinePK

Abstract

The assessment of toxicological concentrations of possible genotoxic contaminants in drug substances was regarded as an important and challenging discipline . The International Conference and Harmonization (ICH) recommended that most pharmaceutical products be allowed to include 1.5 μg/day of a genotoxic contaminant.  The goal  study was to develop a quick and accurate method for measuring potential genotoxic impurities (PGIs) in canaglifoxin drug substance. The chromatographic conditions were appropriately optimized with the columns to achieve a decent separation and response of each impurities peak with the canaglifoxin. According to International conference of Harmonization (ICH) criteria for the quantification of each impurity, method validation for LC-MS was carried out regarding specificity, the limit of detection (LOD), the limit of quantification (LOQ), linearity, accuracy (recovery), precision, and solution stability. Correlation observed in the accuracy during method validation hence method can be considered linear and accurate and can be used for testing of genotoxic impurity in canaglifoxin drug substances.