Review on Nitrosamine: A Potential Genotoxic Impurity

Nitrosamine impurities are a group of chemical compounds that have raised concerns due to their potential carcinogenicity. Nitrosamines are taken orally by humans from food and medicine. N-nitroso compounds (NOC) are exposed by human beings from food, tobacco smoking, medicines and other environmental sources. The recent discovery of nitrosamines made huge changes in the pharmaceutical world. Safety issues has been found in few drugs like valsartan, tetrazole-containing angiotensin-II receptor blockers, ranitidine, and metformin etc… due to the unacceptable levels of N-nitroso compounds. These nitrosamine impurities may form if an amine compound reacts with a nitrosating agent under suitable conditions (viz., temperature, pH etc.) during the manufacturing and storage of the product. To ensure the quality and safety of the drug product, drug regulatory agencies throughout the world have introduced stringent measures on nitrosamine contamination for all drug products in the market. To comply current regulatory requirements, many drug products have been recalled and it causes shortage of medicines in the market. Hence, omission or prevention of nitrosamine impurities in drug products is essential to meet daily medicine needs for human beings and to enhance human lifespan. In this review on Nitrosamine discussed the classifications, Toxicity, acceptable intakes, limit calculations and control measures gives you a significant knowledge and awareness on Nitrosamine.