Apixabana Impureza B (Apixaban Impurity B | também referida como Impureza 59 | CAS 2512213-45-3) é uma impureza processual identificada durante síntese e purificação de apixabana. Caracteriza-se por estrutura relacionada ao princípio ativo e propriedades físico-químicas que exigem monitoramento rigoroso em controle de qualidade farmacêutico. Sua detecção e quantificação são feitas por HPLC acoplado a UV e LC-MS para confirmação de massa | complementadas por RMN para elucidação estrutural. Perfis de estabilidade demonstram potencial formação sob condições específicas de reação e armazenamento | justificando limites especificados em especificações de lote e implementação de medidas de controle de processo e de purificação.
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