ABSTRACT
This chapter scrutinises and investigates the literature to describe the genotoxic impurities (GIs) present in the drug substances/compounds and drug product(s). This chapter begins with a definition of GIs, sources of GIs, their generation, production and categorisation, which is based on their toxicity. The chapter takes into account and explains the various regulatory guidelines to control the GIs in drug compounds/ substances. Analytical basis has been presented for the isolation and qualification of GIs, along with their identification and quantification by diverse analytical methods which have been well described in this chapter.
