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VOL. 10, ISSUE 1 (2025)
A short review on nitrosamine impurities
Authors
Gajula Chandana, Soujanya Chaganti, Nagireddy roshitha
Abstract

Abstract

Since 2018, N-nitrosamine impurities have become a widespread concern in the global regulatory landscape of pharmaceutical products. This concern arises due to their potential for contamination, toxicity, carcinogenicity, and mutagenicity and their presence in many active pharmaceutical ingredients, drug products, and other matrices. These include carcinogenic effects, metabolic disruptions, reproductive harm, liver diseases, obesity, DNA damage, cell death, chromosomal alterations, birth defects, and pregnancy loss. They are particularly known to cause cancer (tumors). Additionally, N-nitrosamine impurities may contribute to the development of Alzheimer’s and Parkinson’s diseases and type-2 diabetes. Therefore, it is very important to control or avoid them by enhancing effective analytical methodologies using cutting-edge analytical techniques such as LC-MS, GC-MS, CE-MS, SFC, etc. Moreover, these analytical methods need to be sensitive and selective with suitable precision and accuracy, so that the actual amounts of N-nitrosamine impurities can be detected and quantified appropriately in drugs. Regulatory agencies such as the USFDA, EMA, ICH, WHO, etc. need to focus more on the hazards of N nitrosamine impurities by providing guidance and regular updates to drug manufacturers and applicants. Similarly, drug manufacturers should be more vigilant to avoid Nitrosating agents and secondary amines during the manufacturing processes. Numerous review articles have been published recently by various researchers, focusing on N-nitrosamine impurities found in previously notified products, including Sartans, metformin, and ranitidine. These impurities have also been detected in a wide range of other products. Consequently, this review aims to concentrate on products recently reported to contain N-nitrosamine impurities. These products include rifampicin, Champix, famotidine, nizatidine, atorvastatin, bumetanide, itraconazole, Diovan, enalapril, propranolol, lisinopril, duloxetine, rivaroxaban, pioglitazones, Glifizones, cilostazol, and sunitinib.
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Pages:30-34
How to cite this article:
Gajula Chandana, Soujanya Chaganti, Nagireddy roshitha "A short review on nitrosamine impurities". International Journal of Pharmaceutical Science and Research, Vol 10, Issue 1, 2025, Pages 30-34
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