This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs. […]

“How do we derisk NDSRIs – not by seeing new sights, but by looking with new eyes?” Aloka Srinivasan, PhD […]

N-nitroso compounds are a family of carcinogens which are formed by the reaction of secondary/tertiary/quaternary amines, alkyl derivatives of amides/ carbamates/urea with nitrite or other nitrogenous agents with the nitrogen in the +3 state.