Acyclovir Impurity N é um subproduto identificado durante a síntese e degradação do aciclovir | cuja presença requer monitoramento analítico e controle de processo rigoroso para garantir a conformidade do produto final. A caracterização estrutural é realizada por técnicas como HPLC acoplada a espectrometria de massas | RMN e análise de impurezas por degradado forçado para elucidar vias de formação. Parâmetros analíticos típicos incluem limites de detecção e quantificação validados | tempo de retenção consistente e fragmentação de massa específica. Avaliação de risco conforme ICH Q3A/Q3B orienta estabelecimento de especificações | estratégias de mitigação na rota sintética e critérios de qualificação relacionados à segurança e estabilidade do API.
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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