GENOTOXIC IMPURITIES IN SMALL MOLECULE DRUG SUBSTANCES: IDENTIFICATION, RISK ASSESSMENT, AND CONTROL STRATEGIES
AbstractImpurities in active pharmaceutical ingredients, especially genotoxic impurities, pose significant risks to patient safety and require stringent regulatory control. This review summarizes key regulatory expectations under ICH Q3A, Q3B, M7, and S2, covering impurity identification, qualification, and control. It discusses major risk-assessment approaches, including toxicological evaluation, genotoxic impurity classification, and acceptable intake determination using compound-specific data or the Threshold of Toxicological Concern. The review also highlights risk-based control strategies based on process understanding, analytical monitoring, and minimization of impurity levels. An integrated approach to impurity management is essential for ensuring product quality, regulatory compliance, and patient safety.
Article Information
24
3576-3584
514 KB
7
English
IJPSR
Dattaprasad G. Bakre
Corporate Quality Assurance, Lupin Ltd. 11th Floor, Empire Tower, Cloud City Campus, Navi Mumbai, Maharashtra, India.
drprasadbakre@yahoo.com
29 June 2026
12 July 2026
25 July 2026
10.13040/IJPSR.0975-8232.17(11).3576-84
01 November 2026
Download