A Acyclovir EP Impurity F (CAS 110104-37-5) | também conhecida como N2-Acetyl Acyclovir ou Acyclovir Related Compound F | é uma impureza acetilada do aciclovir que se forma por N-acetilação ou degradação durante síntese e armazenamento. Sua caracterização requer técnicas analíticas robustas | incluindo HPLC com detector UV | LC-MS e RMN para confirmação estrutural de 9-((2-hydroxyethoxy)methyl)-N2-acetylguanine e quantificação precisa. O acompanhamento e controle desta impureza são essenciais para garantir a pureza do material de partida | otimizar parâmetros de síntese e estabilidade | e cumprir limites estabelecidos pela Farmacopeia Europeia e diretrizes regulatórias.
Referências
Huidobro, A. L., et al. “LC Methods for Acyclovir and Related Impurities Determination.†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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