Impureza Acyclovir EP Impurity P (CAS 23169-33-7) | também denominada 9-(2′-Hydroxyethyl)guanine ou Acyclovir Hydroxyethyl Guanine | é um contaminante de processo identificado no perfil de impurezas do princípio ativo aciclovir. Esta impureza polar pode originar-se por reações secundárias durante a síntese ou por degradação por hidrólise do grupo hidroxietílico | afetando a pureza e a estabilidade dos lotes. A sua identificação e quantificação são realizadas por HPLC com detecção UV e confirmadas por LC-MS e RMN | exigindo limites e controles conforme diretrizes ICH e estratégias analíticas e de purificação robustas.
Referências
Huidobro, A. L., et al. “LC Methods for Acyclovir and Related Impurities Determination.â€Â Journal of Pharmaceutical and Biomedical Analysis, vol. 37, no. 4, Apr. 2005, pp. 687–94, https://doi.org/10.1016/j.jpba.2004.11.039.
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