Determination of Nitrosamines in Various Pharmaceuticals at Variable Temperatures

Abstract

Nitrosamines have been classified as potent genotoxic agents for humans by the International Agency for Research on Cancer. Our study aimed to determine the levels of nitrosamine impurities that could be formed in the content of drugs under different temperature conditions during their shelf life using chromatographic analysis. Eleven drugs in pharmacies were subjected to long-term exposure at two different temperatures. Twelve nitrosamine impurities of all samples were performed using LC-MS/MS. When the impurity levels of the analyzed drugs were examined, no nitrosamine impurity was detected in any drugs. Our study revealed that if no impurity was detected under storage conditions, there was no impurity formation even when the temperature was increased. When impurity formation is effectively prevented during the manufacturing stage, the risk of impurity occurrence during the shelf-life of drugs belonging to the same group is estimated to be low.