OLA-5 Isomer 2 (CAS 2905341-99-1) es una impureza isomérica detectada en perfiles de calidad y estudios de degradación. Su nombre químico (Z)-3-(3-(4-(cyclopropanecarbonyl)piperazine-1-carbonyl)-4-fluorobenzylidene)isobenzofuran-1(3H)-one facilita su identificación espectroscópica. Presenta propiedades fisicoquímicas próximas al principio activo | lo que complica su separación cromatográfica y requiere métodos optimizados HPLC y LC-MS para cuantificación precisa. Se recomienda caracterización por RMN y análisis de estabilidad para evaluar impacto sobre potencia | seguridad y límites de impurezas relacionados. Documentar su presencia en el informe de impurezas y establecer umbrales de aceptación conforme a guías regulatorias es esencial para control de calidad.
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