Impureza Acyclovir EP Impurity H (CAS 133186-23-9) | também denominada N2-acetil aciclovir benzoato | é uma impureza processual identificada durante a síntese e purificação do aciclovir. Quimicamente descrita como 2-[(2-acetamido-6-oxo-1H-purin-9-yl)methoxy]ethyl benzoate | apresenta grupos acetil e benzoato que alteram polaridade e perfil cromatográfico. Relevante para controle de qualidade | sua identificação e quantificação por HPLC com detecção UV e espectrometria de massas são essenciais para cumprir as especificações EP. Estudos de investigação química elucidam vias de formação e condições de reação que promovem sua geração | orientando estratégias de mitigação e limites de aceitabilidade em lotes farmacêuticos.
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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