An Overview of Hyphenated Techniques Used for the Identification of Genotoxic Impurities in Pharmaceutical Products: Current Status and Future Perspectives

Genotoxin is a chemical that has the potential to cause DNA damage, which can result in germline and somatic mutations leading to malignant transformation and cause cancer. The assessment and control of GTIs in pharmaceuticals at trace levels are raising concerns to both the pharmaceutical and regulatory agencies due to this possibility for human carcinogens. Identifying these GTIs at trace levels requires a sophisticated approach, which poses significant challenges for analysts in pharmaceutical research and development. Therefore, it is crucial to understand the various issues related to GTIs and find the potential ways to address them. This article provides a brief overview of the various sources of potential impurities in drug components, such as active pharmaceutical ingredients (APIs), GTIs in food and cosmetics, identification of GTIs using advanced techniques like high-performance liquid chromatography-mass spectroscopy (LC-MS) and gas chromatography-mass spectroscopy (GC–MS). In addition to the sources and identification of GTIs in drug components, the article covers APIs that contain GTIs and their determination using analytical techniques and explores the optimized results obtained from this determination.