Levetiracetam EP Impurity E | sal de hidrocloruro | CAS 10277-86-8 | es una impureza relacionada que requiere atención en control de calidad por su impacto en el perfil de pureza del principio activo. Se caracteriza por mayor polaridad y solubilidad en medios acuosos respecto a la forma libre y suele identificarse y cuantificarse mediante métodos analíticos validados como HPLC con detección UV | LC-MS para confirmación y RMN para elucidación estructural. Puede originarse por rutas de degradación o reacciones secundarias en síntesis y por ello debe incluirse en especificaciones | límites aceptables y procedimientos de eliminación como purificación por cristalización o cromatografía para asegurar cumplimiento de la farmacopea.
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