Impureza isomérica Edoxaban (SRS)-Isomer (CAS 740794-83-6) é uma impureza quiral relevante gerada durante a síntese e condicionamento do edoxaban | podendo surgir por epimerização ou formação de isômeros no processo. Sua presença afeta o perfil de pureza | potência e segurança | exigindo monitoramento rigoroso por HPLC quiral e caracterização por LC-MS e RMN. Estratégias de controle incluem otimização da rota sintética | controles de processo e limites de especificação alinhados às orientações ICH Q3A/Q3B e avaliação toxicológica quando necessário. Estudos de estabilidade e métodos analíticos validados são essenciais para assegurar conformidade regulatória e qualidade do material farmacêutico.
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