Apixaban Inhouse Impurity C | também referida como Apixaban Impurity 21 ou Desmethoxy Apixaban | é uma impureza identificada no perfil de impurezas da apixabana | resultante da perda do grupo metoxi durante a síntese ou degradação. Caracteriza-se por deslocamento cromatográfico distinto em HPLC e confirmação por LC-MS e RMN | exigindo métodos analíticos validados para quantificação. Sua presença é monitorada como indicador de controle de processo e estabilidade | com especificações e limites de aceitação definidos para garantir conformidade regulatória. Estudos de forçamento ajudam a esclarecer vias de formação e estratégias de purificação para reduzir níveis e mitigar riscos ao produto final.
Referências
Hurst, Katherine, et al. “Quick Reference Guide to Apixaban.” Vascular Health and Risk Management, vol. Volume 13, July 2017, pp. 263–267, 10.2147/vhrm.s121944.
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