Impurity profiling involves identifying and characterizing known and unknown contaminants in drug products to enhance drug safety. Regulatory organizations such as the ICH, EMEA, and USFDA have established guidelines to limit impurity levels in drug substances and products. Among the most concerning categories are genotoxic and chiral impurities, which can potentially induce human carcinogenesis even at low concentrations. This has led to increased scrutiny from regulatory bodies and the pharmaceutical industry, necessitating more rigorous analysis and control by manufacturers. The reactive and unstable nature of these impurities presents significant analytical challenges, especially in identifying and managing them at trace levels in accordance with toxicological thresholds and daily dose requirements. This review paper offers a comprehensive overview of the current challenges in chiral and genotoxic profiling, along with the regulatory landscape and their significance in the pharmaceutical industry. It also explores various methods for impurity profiling, including chromatographic and spectroscopic techniques, as well as emerging methods like mass spectrometry imaging.

Dr. Ojaskumar D. Agrawal, Shruti Khandave, Asrin Khan, Dr. Anita Ayre

Impurity profiling, Chiral impurity, Genotoxic impurity, Regulatory guidelines