N1-((1S | 2R | 4S)-2-Amino-4-(dimethylcarbamoyl)cyclohexyl)-N2-(5-chloro pyridin-2-yl)oxalamide (CAS 480452-37-7) é uma impureza relacionada estruturalmente ao composto alvo que se caracteriza por alta polaridade e múltiplos sítios de protonação | conferindo perfil cromatográfico distinto e boa ionização em LC-MS. Sua formação é associada a reações secundárias de acilação e hidrólise parcimoniosa durante etapas sintéticas e de purificação. Para controle analítico recomenda-se HPLC reverso com deteção UV complementada por LC-MS para identificação e quantificação | avaliação de estabilidade em condições ácido-base e implementação de limites de aceitação e estratégias de purge no processo.
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