Apixaban Impurity 28 (CAS 2208275-54-9) é uma impureza relacionada ao ingrediente farmacêutico ativo com estrutura 6-(4-(3-hidroxi-2-oxopiperidin-1-yl)fenil)-1-(4-metoxifenil)-7-oxo-4 | 5 | 6 | 7-tetrahidro-1H-pirazolo[3 | 4-c]piridina-3-carboxamida | apresentando grupos funcionalizados que conferem maior polaridade relativa e pontos de fragmentação característicos em espectrometria de massa. Seu perfil analítico exige métodos cromatográficos seletivos como HPLC acoplado a MS e quantificação por padrões internos | além de confirmação por RMN para diferenciação de isómeros. Considerações de estabilidade | limites de aceitação e desenvolvimento de métodos de purificação são essenciais para controle de qualidade e conformidade regulatória no monitoramento de impurezas relacionadas ao processo.
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