26.5 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-desmethyl-escitalopram (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
Nitroso-Escitalopram ESTRC-1, também designado N-Nitroso Desmethylcitalopram, é uma impureza do tipo nitrosamina associada ao espaço químico de citalopram e escitalopram. Com fórmula molecular C19H18FN3O2 e massa molecular de 339.36 g/mol, apresenta a funcionalidade N-nitroso sobre o esqueleto amínico desmetilado. Essas espécies podem surgir por nitrosação de precursores de amina secundária durante o processo ou armazenamento, e, no contexto da ICH M7, são consideradas potencialmente mutagênicas, exigindo frequentemente avaliação toxicológica específica. A caracterização depende tipicamente de LC-MS/MS com confirmação por espectrometria de alta resolução, enquanto GC-MS pode ser aplicado quando volatilidade e estabilidade térmica o permitem. A quantificação requer controle rigoroso de contaminação em níveis traço e efeitos de matriz.
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