Title : Analytical methods based on liquid chromatography tandem mass spectrometry for the detection of genotoxic nitrosamine impurities
Abstract:
The presence of genotoxic impurities like nitrosamine in pharmaceutical products has become a pressing global safety concern due to their potential carcinogenic and mutagenic e8ects. NAs, particularly N-nitroso compounds, are classified as probable human carcinogens, raising the need for stringent regulatory oversight and innovative approaches to detect and mitigate their occurrence. This review highlights recent advancements in the detection, quantification, and analysis of these impurities, using liquid chromatography mass spectrometry. Her we also explores the origins and pathways of nitrosamine formation during drug synthesis, storage, and degradation, emphasizing the critical role of risk assessment and quality control in pharmaceutical manufacturing. Furthermore, we are going to discusses the evolving regulatory landscape, including the impact of stringent guidelines from agencies such as the FDA and EMA, on industry practices. By addressing these challenges and presenting solutions, this article underlines the importance of robust impurity monitoring systems to ensure the safety, e8icacy, and quality of pharmaceutical products, thereby safeguarding public health.
