Annual Nitrosamines Workshop

The USFDA issued its final guidance on Nitrosamine drug substance related impurities in August with a completion deadline on 1st November 2023. The EMA also revised their guideline in July 2023 to include Carcinogenic Potency Categorization Approach (CPCA) and the enhanced Ames test (EAT) for establishing acceptable intakes (AIs) for N-nitrosamines. The research and regulations on Nitrosamines are constantly evolving which emphasizes on the need for continuous discussions on the latest developments on the subject.