Rivaroxaban Impurity III (CAS 1074-82-4) | também referido como Potassium Phthalimide ou Phthalimide Potassium Salt | é uma impureza observada durante a síntese do rivaroxaban | originada de intermediários e sais de potássio. Quimicamente corresponde ao sal de potássio da isoindolina-1 | 3-diona | com solubilidade favorecida em solventes polares e estabilidade térmica moderada. A sua identificação e quantificação requerem técnicas analíticas robustas como HPLC com detecção UV | LC-MS e RMN para garantir sensibilidade e seletividade. Estratégias de controle incluem purificação direcionada | lavagem de fases | cristalização e monitoramento em processo para reduzir níveis abaixo de limites aceitáveis. O perfil dessa impureza deve ser caracterizado e documentado no controle de qualidade.
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