Impureza Meclizina N | N-dióxido (CAS 114624-70-3) | identificada también como 1-[(4-clorofenil)-fenilmetil]-4-[(3-metilfenil)metil]-1 | 4-dioxidopiperazina-1 | 4-diium | representa un subproducto oxidado generado durante etapas de síntesis y purificación; su presencia requiere control por su impacto en el perfil de calidad. El análisis se basa en métodos validados como HPLC con detección UV | LC-MS y espectrometría de masas para identificación y cuantificación en niveles trazas. La impureza muestra sensibilidad a condiciones ácidas y oxidativas y su gestión incluye optimización de condiciones de reacción | cromatografía preparativa y límites de aceptación fundamentados en evaluaciones toxicológicas y de riesgo.
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