From Valsartan to Metformin – notorious impurities in drug products
Since June 2018, various N-nitrosamines have been detected worldwide in active pharmaceutical ingredients (API) of multiple manufacturers. Two referral procedures were started in the EU, referring to sartans (July 2018) and to ranitidine (Sept 2019).
N-nitrosamines are classified as probably carcinogenic to humans. Strict interim limits up to less than 1 ppm in the API have been established. This will be lowered to 30 ppb after a transitional period of 2 years. These limits represent a major challenge for the current technical state of ultra-trace analytics. Analytical methods must (...)