Abstract

NITROSAMINE IMPURITIES IN PHARMACEUTICAL PRODUCTS: DETECTION, MITIGATION STRATERGIES AND REGULATORY MEASURES

Keshav Hirave*, Vishwas Jibhakate, Kunal Kamdi, Pratik Sikdar, Kamlesh Wadher, Millind Umekar

ABSTRACT

Nitrosamines are a class of chemical compounds that are formed when a nitrogen atom is linked to an oxygen atom via a nitrogen-oxygen double bond. They are known to be carcinogenic, and have been linked to several different types of cancer, including lung cancer, stomach cancer, and liver cancer. Nitrosamines can be found in a variety of different environmental sources, including tobacco smoke, cured meats, and some industrial chemicals. They can also be found in some pharmaceutical products. The presence of nitrosamine impurities in pharmaceutical products is a serious concern, as it could potentially increase the risk of cancer for patients who take these products. In recent years, there have been a number of high-profile recalls of pharmaceutical products that have been found to contain nitrosamine impurities. The review paper aims to comprehensively examine the presence, detection, and control of nitrosamine impurities. It focuses on the significance of these impurities, their potential health risks, and the regulatory response to this emerging concern. Also provides insights into the various pathways through which nitrosamine impurities can form in pharmaceuticals. It discusses the health implications of these impurities, regulatory guidelines, analytical methods for detection, and preventive strategies. The paper aims to consolidate knowledge and contribute to ensuring the safety and quality of pharmaceutical products by addressing the issue of nitrosamine impurities.

Keywords: Nitrosamines, Carcinogenicity, Pharmaceutical Product, Regulatory guideline.