Nitrosamine impurities in pharmaceutical dosage forms: Current challenges and mitigation strategies

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.