EMA: Updated Appendix 1 of the Nitrosamine Q&As
The European Medicines Agency (EMA) updated Appendix 1 (EMA/307633/2024 /Rev. 5) of the Nitrosamine Q&As, listing nitrosamines with established Acceptable Intake (AI) values.
The update includes re-evaluated AI values for nitrosamines related to DIPEA (N,N-diisopropylethylamine) (NDIPA (N-nitrosodiisopropylamine) and NEIPA (N-nitrosoethylisopropylamine)) and NMP (N-methyl pyrrolidinone) (NMBA (N-Nitrosomethylaminobutyric Acid)) according to CPCA (carcinogenic potency categorisation approach) standards, resulting in significant increases. Additionally, new nitrosamine drug substance-related impurities (NDSRIs) associated with the manufacturing processes of several active substances have been added (e.g. Cinnarizine, Clarithromycin, Tramadol, Valsartan).
Updates to AI values have also been made for other NDSRIs, such as Nitroso-STG-19 from Sitagliptin and N-nitroso-desmethyl-citalopram, and some other corrections have been made.
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