Impureza Acyclovir EP Impurity D (CAS 59277-91-7) | também referida como Acyclovir Benzoate ou 9-(benzoyloxyethoxymethyl)guanine | é um subproduto de benzoylação observado durante a síntese e purificação do aciclovir. Esta impureza altera o perfil de pureza do intermediário final e requer monitorização por métodos analíticos validados | tipicamente HPLC-UV | LC-MS e RMN para confirmação estrutural. O controle de lote inclui limites de especificação | investigação de origem e otimização de processo para minimizar formação. Características cromatográficas e espectrais bem definidas facilitam sua quantificação em ensaios de estabilidade e controle de qualidade | assegurando conformidade com monografias e boas práticas analíticas.
Referências
Sinha, V. R., et al. “Stress Studies on Acyclovir.†Journal of Chromatographic Science, vol. 45, no. 6, July 2007, pp. 319–24, https://doi.org/10.1093/chromsci/45.6.319.
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