Nitrosamine Contamination in Pharmaceuticals: A Comprehensive Review on Nitrosation Pathways, Potential Root Cause, Detection, Risk Assessment, and Mitigation Strategies

Snehal Ukhade* and Sandeep Sonawane

Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Affiliated to Savitribai Phule Pune University, Adgoan Nashik, India.

Corresponding author E-mail:snehalukhade712@gmail.com

DOI : http://dx.doi.org//10.13005/bbra/3272

ABSTRACT: N-nitrosamines, recognized as potentially fatal and likely human carcinogens, have been detected in various medications, including antidiabetic drugs and Histamine-2 receptor blockers, particularly those with specific amine structures. This contamination has prompted regulatory bodies to implement rigorous testing and mitigation strategies to safeguard public health. This review offers a concise overview of nitrosamine impurities, their precursors, affected medications, and associated health risks. Current regulations stress the need for robust analytical procedures to detect and mitigate nitrosamines, such as using nitrite scavengers in oral medications. Despite these efforts, challenges remain in accurately assessing risks and integrating effective detection methods. Key findings indicate a need for continuous monitoring, advancements in detection technologies, and the development of comprehensive risk assessment frameworks. Recommendations include adopting proactive risk management strategies, enhancing industry collaboration for better data sharing, updating regulatory guidelines, and incorporating country-specific risk mitigation efforts to address emerging threats effectively.

KEYWORDS: Analytical Method; Carcinogenic nitrosamine impurities; Nitrosamine formation; Nitrite scavenger; Risk Evaluation

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