Acyclovir Impurity 3 es una impureza estructuralmente relacionada con el núcleo purínico de aciclovir | descrita como N-(9-((2-((2-acetamido-6-oxo-1 | 6-dihydro-7H-purin-7-yl)methoxy)ethoxy)methyl)-6-oxo-6 | 9-dihydro-1H-purin-2-yl)acetamide. Se caracteriza por alta polaridad y masas moleculares compatibles con aductos purínicos | y se detecta y cuantifica rutinariamente mediante HPLC con detección UV y LC-MS para confirmación de masa | complementado por espectroscopía NMR para elucidación estructural. Su formación se asocia a reacciones secundarias en etapas de acilación o etoxilación y requiere controles de proceso | purificación y especificaciones según guías regulatorias ICH. La gestión incluye límites de aceptación | métodos validados y estudios de estabilidad para garantizar calidad y seguridad del principio activo.
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