Analytical Standards of Nitrosamines for Pharmaceutical, Food, and Water Environment Analysis

Nitrosamines are compounds of the chemical structure where hydrogen of the amine nitrogen is substituted with a nitroso group. And these are known to be carcinogenic. 

Nitrosamines are compounds of the chemical structure where hydrogen of the amine nitrogen is substituted with a nitroso group. These compounds are widely used industrially in plasticizers, additives, etc., but at least some of them are known to be carcinogenic.Nitrosamine are also formed by reaction of secondary amine and nitrous acid. Therefore, they are often detected as impurities during the manufacturing process of a drug product. Recently, nitrosamines were detected in some sartan and ranitidine products, and these products were recalled. In response to this event, in September 2019, the EMA (European Medicines Agency) requested the marketing authorization holders to evaluate the risk of the presence of nitrosamine impurities in their drugs and take appropriate risk mitigation measures. Fujifilm Wako offers a wide range of analytical standards of nitrosamines