9-Oxo Epinastine (HCl) (CAS 141342-69-0) es una impureza relacionada que aparece durante la síntesis y el almacenamiento de epinastina. Se caracteriza por la presencia de un grupo cetona en posición 9 | lo que modifica su perfil fisicoquímico y su comportamiento en cromatografía. Su identificación y cuantificación requieren métodos analíticos validados como HPLC con detección UV | LC-MS para confirmación de masa y RMN para elucidación estructural. La presencia de 9-Oxo Epinastine (HCl) puede afectar la pureza del lote y debe controlarse mediante especificaciones de límite | estudios de estabilidad y estrategias de mitigación en control de procesos para cumplir requisitos regulatorios.
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