O (S)-N-didesmetil citalopram (sal oxalato) (CAS 166037-78-1) é uma impureza crítica no desenvolvimento e controle de qualidade de citalopram | formada por desmetilação N inadvertida durante etapas sintéticas ou desgaste catalítico. Caracteriza-se por comportamento cromatográfico e espectral próximo ao API | exigindo métodos seletivos como HPLC analítico | HPLC quiral | LC-MS e RMN para identificação e quantificação confiáveis. Sua presença pode afetar a pureza enantiomérica e a conformidade com perfis de impurezas; portanto | estratégias de mitigação incluem otimização de condições reacionais | etapas de purificação específicas e monitoramento de estabilidade em forma de sal oxalato. Padrões de referência e limites específicos suportam controle e investigação de desvios.
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