Edoxaban (RSR)-Isomer (Mesylate Salt) é uma impureza estereoquímica relevante no desenvolvimento e controle de qualidade do edoxabana | referida também como Ent-Edoxaban ou Edoxaban Impurity I. Apresenta propriedades físico-químicas distintas como configuração RSR e forma salina mesilato | exigindo métodos específicos de identificação e quantificação. O perfil analítico normalmente inclui HPLC quiral | espectrometria de massa e RMN para confirmação estrutural e determinação de limites de aceitação. A monitorização desta impureza é crítica para garantir conformidade com guias regulatórios | estabilidade do produto e a integridade do perfil de pureza do material farmacêutico.
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