Corresponding author: Krishna Radheshyam Gupta.
Copyright © 2023 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0.
Nitrosamine impurities in pharmaceutical dosage forms: Current challenges and
mitigation strategies
Monali Rushi Dakhole, Krishna Radheshyam Gupta
*
and Milind Janrao Umekar
Department of Pharmaceutical chemistry, Smt Kishoritai Bhoyar College of Pharmacy, Kamptee, Nagpur, India.
International Journal of Frontiers in Chemistry and Pharmacy Research, 2023, 03(01), 042–052
Publication history: Received on 19 July 2023; revised on 08 September 2023; accepted on 10 September 2023
Article DOI: https://doi.org/10.53294/ijfcpr.2023.3.1.0052
Abstract
Nitrosamine impurities have been detected in various pharmaceutical products in nowadays. These impurities are
classified as probable human carcinogens and can be found in a wide range of products including pharmaceuticals,
industrial chemicals and food. This review paper provides a comprehensive analysis of nitrosamine impurities in
Pharmaceutical dosage forms. It covers the formation and sources of nitrosamine impurities, allowable daily intake
impurities limit (ng/day), the analytical methods employed for their detection. Various methods including LC-MS, GC-
MS and HPLC for nitrosamine impurities, regulatory guidelines, notable incidents, case studies and the impact of
nitrosamine impurities contamination on the pharmaceutical landscape and additionally, case studies of previous
incidents involving nitrosamine-contaminated pharmaceutical products. Furthermore, this overall review provides
outlines the current mitigation strategies, risk assessment, future directions and challenges adopted by pharmaceutical
companies to ensure Drug safety and regulatory compliance in worldwide also provides a comprehensive examination
of the current state of knowledge regarding nitrosamine impurities in pharmaceutical dosage forms.
Keywords: Nitrosamine Impurities; Formation and sources of Nitrosamines; Analytical Methods; Regulatory
Guidelines; Mitigation Strategies
Graphical abstract