Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
The toxicological valuation genotoxic impurities and assessment of acceptable levels for such impurities in any pure drug and its formulations is a significant as well as very difficult issue. The European Medicines Agency guided that 1.5 μg/day intake of a genotoxic impurity was considered as acceptable for most of the pharmaceutical products. In view of this, the present work was intended to develop a sensitive, simple and accurate LCMS method for the quantification of potential genotoxic impurities (PGIs) such as N-oxide impurity, N-formyl impurity,