Información adicional sobre el Acyclovir EP Impurity Q
Fármaco de origen
Acyclovir
Nombre IUPAC
2-Amino-9-(((2-hydroxyethoxy)methoxy)methyl)-1,9-dihydro-6H-purin-6-one compound with 2-amino-9-((2-(hydroxymethoxy)ethoxy)methyl)-1,9-dihydro-6H-purin-6-one (1:1)
Sinónimos
N/A
Descripción
La impureza Q de aciclovir EP es una impureza nucleosídica estructuralmente relacionada, con fórmula C18H26N10O8 y peso molecular 510.46. Su composición sugiere un análogo de guanina altamente funcionalizado, coherente con un subproducto sintético oxidado o sobreacilado más que con un residuo de proceso simple. Estas especies pueden generarse durante secuencias multietapa de protección, glicosilación o desprotección final empleadas en la fabricación de aciclovir. Dado que las impurezas de purina estrechamente relacionadas pueden comprometer la especificidad del ensayo y el perfil de impurezas, su caracterización suele requerir LC en fase reversa acoplada a MS de alta resolución, con apoyo frecuente de fragmentación MS/MS y métodos ortogonales LC-UV para resolución a nivel traza.
Referencias
O’Brien, John J., and Deborah M. Campoli-Richards. “Acyclovir.†Drugs, vol. 37, no. 3, Mar. 1989, pp. 233–309, 10.2165/00003495-198937030-00002.
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