Nitrosaminas em insumos farmacêuticos ativos

Abstract

Since 1972, N-nitrosamines have been the subject of study in medication composition. However, in July 2018, the presence of the N-nitrosamine NDMA was identified in Valsartan, leading to the recall of this medication. Subsequently, in August 2018, there were also recalls of Losartan and Irbesartan. Following this milestone, studies on these organic compounds, characterized by the presence of an amine group linked to a nitroso group, have been constantly advancing, prompting regulatory revisions aimed at consumer safety. To prevent medication shortages, guidelines and resolutions have been developed to assist in assessing and controlling risks, considering acceptable limits for daily intake. Consequently, there was a need to understand the pathways of formation of these impurities during the manufacturing process of both pharmaceutics and medications. In this context, this study aimed to evaluate potential formation routes of these impurities and how we can establish their limits, assessing whether there is proper control over nitrosamines.