Impureza Rivaroxaban Impurity II (CAS 85-41-6) | conhecida também como o-Phthalic imide | 1 | 3-Isoindolinedione | 1 | 2-Benzenedicarboximide e 1 | 3-Isoindoledione | é um degradante aromático observado em vias sintéticas e condições de armazenamento que pode afetar o perfil de pureza do fármaco. A sua identificação e quantificação requerem técnicas analíticas robustas como HPLC com detecção UV | espectrometria de massas e RMN para confirmação estrutural. A presença desta impureza tem implicações regulatórias e toxicológicas | exigindo limites especificados | estratégias de controlo de processo | otimização de formulação e validação de métodos analíticos para assegurar conformidade e segurança do produto final.
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