Apixaban Impurity 57 é uma impureza relacionada ao processo de síntese de apixabana que exige controle robusto no desenvolvimento e produção farmacêutica. Caracteriza-se por um perfil analítico específico detectável por HPLC e LC-MS e necessita de confirmação estrutural por RMN quando requerido. Seu monitoramento deve contemplar limites de especificação baseados em ICH Q3A e Q3B | avaliação de toxicidade potencial e estudos de estabilidade para identificar vias de degradação. Métodos validados de quantificação com sensibilidade adequada | investigação de origem e relatórios de perfil de impurezas são essenciais para garantir conformidade regulatória e segurança do produto final.
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