N-nitrosamines in pharmaceuticals

Nitrosamines are a class of organic compounds that are characterized by the presence of a nitroso group bonded to a saturated nitrogen atom. They are typically formed from the reaction of secondary or tertiary amines with nitrosating agents, which often occur in the presence of nitrites and acidic conditions.

The European Medicines Agency (EMA) requires pharmaceutical companies to assess the risk of nitrosamine presence in pharmaceutical products, including Active Pharmaceutical Ingredients (APIs) and finished products.

As reported in EMAs latest revision of their guidance document on nitrosamine impurities in medicinal products, the regulatory authority has updated the list of nitrosamines and nitroso APIs to be monitored and the relative limits for these molecules. Examples of N-nitrosamines whose presence should be monitored include NDMA and NDEA.