Presenter : Dr. Loren Gelber | Duration : 60 Minutes
The recent recalls of sartan antihypertensives due to the presence of nitrosamines may suggest increased attention from FDA to toxic impurities in drug products from active pharmaceutical ingredients (APIs). Valsartan, Losartan and Irbesartan drug products have recently been recalled due to the presence of the carcinogens N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) orN-nitroso-N-methyl 4-amino butyric acid (NMBA). These carcinogens were found to be present above the low interim specifications recently established by FDA.
The analytical method used to find these substances will be discussed. The public information about how they got into these drug products, and its implications for the future, will be considered. European Medicines Agency position on nitrosamines will also be presented. This training will provide valuable information to those who plan and conduct cleaning validations and analyses of APIs, as well as pharma company management.
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