An update on latest regulatory guidelines and analytical methodologies for N-nitrosamine impurities in pharmaceutical...

Controlling or eliminating N-nitrosamine impurities in pharmaceutical products has become a significant challenge for both drug manufacturers and regulatory authorities. This difficulty is particularly pronounced in light of the recent increase in nitrosamine drug substance-related impurities, which have raised concerns about the safety and efficacy of various medications. Additionally, the pharmaceutical industry faces the challenge of developing analytical methods that are not only sensitive and selective but also precise and accurate. These methods are crucial for the reliable quantification of low levels of N-nitrosamine impurities, ensuring compliance with stringent current regulatory guidelines. The intricate nature of detecting these impurities at such low levels necessitates the use of cutting-edge analytical techniques, such as liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry. In light of these challenges, this review article explores the latest regulatory guidelines and analytical methodologies concerning N-nitrosamine impurities in various pharmaceutical products for 2024. Findings from this review article help provide valuable insights for researchers and industry professionals to enhance the safety and quality of pharmaceutical products.