Acyclovir EP Impurity E (CAS 374697-95-7) | também designada Iso-Acyclovir e quimicamente descrita como 6-amino-9-((2-hidroxietoxi)metil)-3 | 9-dihidro-2H-purin-2-ona | é uma impureza crítica monitorada no perfil de qualidade de princípios ativos de aciclovir. Sua identificação e quantificação por técnicas cromatográficas como HPLC e espectrometria de massas são essenciais para assegurar conformidade com especificações farmacopêicas. Características físico-químicas | comportamento em processos de síntese e estabilidade sob condições de armazenamento são avaliados para controlar níveis residuais | estabelecer limites aceitáveis e orientar procedimentos de purificação. Fornecemos material de referência e dados analíticos para suporte regulatório e desenvolvimento de métodos.
Referências
?Sinha, V. R., et al. “Stress Studies on Acyclovir.†Journal of Chromatographic Science, vol. 45, no. 6, July 2007, pp. 319–24, https://doi.org/10.1093/chromsci/45.6.319.
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