1500 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-albuterol (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
Descrição
N-Nitroso Salbutamol, também denominado N-Nitroso Albuterol ou Salbutamol Nitroso Impurity 1, é uma impureza nitrosamina associada à química de agonistas β2 e representa um alerta estrutural para potencial genotoxicidade. Apresenta CAS 2919946-71-5, fórmula molecular C13H20N2O4 e massa molecular de 268.3 g/mol. A sua formação pode ocorrer por condições nitrosantes sobre a função amina secundária durante a síntese, o armazenamento ou a exposição a excipientes contendo nitrito. Devido à expectativa de ocorrência em nível traço e ao enquadramento toxicológico segundo ICH M7, a identificação e a quantificação exigem normalmente LC-MS/MS altamente seletiva, frequentemente complementada por HRMS ou GC-MS.
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