ISSN 2063-5346
For urgent queries please contact : +918130348310

A Comprehensive Review: Structure Based N-Nitrosamine Impurity Risk Assessment of an Anti-Coagulant Drug Rivaroxaban

Main Article Content

Kedarnath Birajdar1, Sudhakara A2*, Shubhrajyotsna Aithal1, Praveen B M1*, Prashanth Kumar Babu1
» doi: 10.48047/ecb/2023.12.12.201


In the recent years, presence of N-Nitrosamine impurity in the drug substance as well in the drug product became the critical and serious concern. The drugs in the Sartan family have been recalled from market due to presence of N-Nit rosamine Nit rosamine impurities are carcinogenic and could cause cancer to human1-9. The multiple root causes of nitrosamine contamination listed in the literature can occur within the API Manufacturing process. Therefore, multiple strategies may be necessary to identify all potential source10-18. Regulatory agencies have recommended the through N-Nitrosamine risk assessment, nanogram level quantification analytical methods and control in the API manufacturing process19-26.

Article Details