N. Hari Priya1, V. Vatsnavika1, T. Himaja1, M. Hemanth Kumar1, B. Harihanth Desay1, P. Srinivasa Babu2, A. Bhavani Sailu1*

GENOTOXIC IMPURITIES IN PHARMACEUTICALS: ADVANCES IN RISK ASSESSMENT, ANALYTICAL STRATEGIES, REGULATORY PERSPECTIVES, AND CONTROL APPROACHES

Genotoxic impurities (GTIs) are trace-level contaminants capable of damaging DNA and increasing the potential for mutation and carcinogenesis. They may arise from starting materials, reagents, catalysts, intermediates, by-products, degradation pathways, manufacturing operations,...