Nitroso Escitalopram EP Impurity C é uma impureza relacionada identificada no perfil de pureza do escitalopram conforme monografia EP. Quimicamente caracterizada pela função nitroso | sua presença indica vias de degradação por nitrosação e requer atenção regulatória devido ao potencial risco genotóxico associado a derivados nitrosos. Para controlo de qualidade é necessária quantificação sensível por HPLC acoplada a detecção UV e confirmação por LC-MS/MS | com limites de deteção e quantificação validados | recuperações e precisão estabelecidas. Estudos de estabilidade | forças de formação e estratégias de mitigação são essenciais para garantir conformidade do lote e segurança do produto farmacêutico.
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