Formation and Inhibition of Nitrosamines in Drug Product

19 September 2023 13:45 - 14:15

Nitrosamines, in the absence of toxicological data, are regarded as potential mutagens, and ICH M7 considers N-nitrosamines as part of the highly mutagenic cohort of concern. Recently, several drug withdrawals have been resulted from the contamination of drugs with nitrosamines. To ensure patient safety and access to life saving drugs, it is important to understand the phenomenon of the formation of nitrosamines in drug products and how to inhibit the formation of nitrosamines in drug products. We will present data, primarily, on the formation and inhibition of formation of nitrosamines in solid oral dosage form.

Kausik Nanda, Principal Scientist , Merck