The present work is based on a assess analysis of the literature in order to define the genotoxic impurities present in the
drug substances and drug products. Starting from the definition of genotoxic impurities, sources of genotoxic impurities, their
generation and classification based on their toxicity. The article also explains the various regulatory guidelines to control the
genotoxic impurities in drug substances. Isolation, qualification of impurity and its identification along with quantification by the
various analytical methods is also described in this review article.
Keywords: Impurities; Genotoxic; Classification; Guidelines; Drug substances