Regulatory Considerations of Nitrosamine Impurities as Per EMA and USFDA Guidelines

Abstract

A class of carcinogenic substances known as nitrosamine impurities can be discovered in a wide range of products, including food, medications, and consumer goods. Nitrites or nitrates react with secondary amines to produce nitrosamines as a byproduct. Due to their potential to cause cancer in patients, nitrosamine impurities have attracted a lot of attention in the pharmaceutical sector recently. As a result, regulatory agencies around the world have established strict guidelines for the control and detection of nitrosamine impurities in pharmaceuticals. Moreover, manufacturers also have to conduct regular testing to ensure compliance. The various types of nitrosamine derivatives along with their detection methods in certain drugs such as ranitidine and rifampicin are discussed in the following review article.