A Acyclovir EP Impurity M (CAS 91702-60-2) é uma impureza processual identificada durante síntese e purificação de aciclovir. Quimicamente descrita como N | O-diacetato isoacyclovir ou 2-[(2-acetamido-6-oxo-3H-purin-7-yl)methoxy]etil acetato | apresenta massa molecular e características cromatográficas distintas que requerem monitorização rigorosa. Sua presença acima de limites específicos pode indicar reações de acetilação ou condições de esterificação incompletas. Métodos analíticos validados como HPLC com detecção UV | LC-MS e RMN são recomendados para quantificação e identificação estrutural. O controle desta impureza é crítico para conformidade com especificações farmacêuticas e garantia de qualidade do lote final.
Referências
O’Brien, John J., and Deborah M. Campoli-Richards. “Acyclovir.†Drugs, vol. 37, no. 3, Mar. 1989, pp. 233–309, https://doi.org/10.2165/00003495-198937030-00002.
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