Nitrosamine impurity detection: unravelling the analytical puzzle
Shruti Nilakh1* and Sonali Mahaparale2
1Dr. D.Y. Patil College of Pharmacy, Akurdi, Pune - 411044 (India) nilakhshruti@gmail.com sonalimahaparale@dyppharmaakurdi.ac.in Corresponding author- Shruti Nilakh Email- nilakhshruti@gmail.com Mobile No- 9359169902
ABSTRACT
Because of their strong Genotoxic and Mutagenic properties, N-nitro compounds, especially N-nitrosamines, have caused concerns about worldwide safety when they are present in pharmaceutical goods. A number of medicines were taken off the market because of the high limit of nitrosamine contamination. This paper aims to provide a succinct overview of nitrosamine impurities, including their mode of action, precise detection techniques, sample preparation steps, and regulatorylimitations. Chemical structural analysis has also been done on a number of reported nitrosamine pollutants. This review paper covers nitrosamine impurity detection methods like GC-MS-HS and HPLC. Furthermore evaluated in the study is the Decoding Nitrosation Assay: Exploring Innovative Approaches for Detection this will likely be used as a preventive measure in the future to find any potential nitrosation, N-nitro contamination, or other possibly mutagenic pollutants throughout the drug development process.