Apixaban Impurity 69 (CAS 1017663-55-6) é uma impureza crítica no perfil de qualidade do apixabana que requer monitoramento contínuo e métodos analíticos robustos; caracteriza-se por propriedades fisicoquímicas que complicam sua separação por cromatografia líquida e pode coeluir com impurezas relacionadas | tornando necessária a utilização de LC-MS/MS de alta resolução e RMN para confirmação estrutural. Estudos de estabilidade indicam formação sob condições de oxidação e pH extremo | afetando limites de especificação conforme ICH Q3A/Q3B. O controle inclui desenvolvimento e validação de métodos seletivos | estabelecimento de limites de rejeição e documentação para atendimento regulatório e garantia da qualidade farmacêutica.
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