Abacavir EP Impurity D (Free Base) (CAS 783292-37-5) es una impureza relacionada con el principio activo | caracterizada por la unidad purínica 2-amino-6-(ciclopropilamino) y el fragmento ciclopent-2-en-1-ol en configuración (1R | 4R) trans. Presenta basicidad moderada y comportamiento cromatográfico de retención intermedia | lo que facilita su separación por HPLC y su identificación por LC-MS y detección UV en longitudes de onda típicas de bases purínicas. Su control es esencial en el perfil de impurezas conforme a guías ICH | por su estabilidad variable en condiciones ácidas y básicas y su tendencia a formar sales; requiere caracterización completa y cuantificación validada con límites especificados.
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