Nitrosamine Impurities
FDA has been investigating the presence of nitrosamine impurities in certain drug products. Since 2018, several drug products including ARBs, ranitidine, nizatidine, and metformin have been found to contain unacceptable levels of nitrosamines.
We also developed our intelligence and contributing to society to estimate the accurate content of nitrosamine impurities. We have rich experience in developing and validating analytical methods for various drug substances and drug products.
We have Shimadzu LCMS/MS, Model: LCMS-8045, with updated software Lab Solution Version 6.91. In more than 50 projects, we identified and quantified more than 10 different types of nitrosamine impurities, by considering allowable maximum daily exposure target.
