Meclizine o-cloro Isómero (CAS 713071-37-5) es una impureza posicional derivada de la cloración del núcleo del meclizine que requiere control riguroso en el perfil de impurezas del ingrediente farmacéutico activo. Su identificación y cuantificación se realizan mediante HPLC unido a detección UV y LC-MS para confirmación de masa, complementadas con RMN para asignación estructural. La presencia de este isómero puede afectar pureza, estabilidad y cumplimiento de especificaciones reglamentarias, por lo que se recomienda establecer límites de aceptación, métodos de separación cromatográfica validados, estrategias de limpieza del proceso y pruebas de degradación forzada para su calificación. Referencias de patrón y documentación completa son esenciales.
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