Nitroso Escitalopram EP Impurity A é uma impureza nitroso identificada no perfil de pureza do escitalopram conforme monografia da Farmacopeia Europeia. Quimicamente classificada como derivado nitroso | exige monitorização rigorosa devido ao potencial de genotoxicidade | e sua quantificação é realizada por métodos analíticos validados como HPLC com detecção UV e LC-MS/MS para confirmação de massa exata e fragmentação. Estudos de formação indicam conversões por nitrosação de aminas secundárias durante síntese ou armazenamento em presença de nitritos. O estabelecimento de limites | estratégias de redução e documentação conforme ICH Q3A | Q3B e M7 são essenciais para conformidade regulatória.
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