Epinastine Impurity 5 (CAS 74860-00-7) | también denominada 9 | 13b-dihidro-1H-dibenzo[c | f]imidazo[1 | 5-a]azepin-3-amine hydrochloride | es una impureza relacionada estructuralmente que requiere control analítico riguroso. Se caracteriza por su forma salina que altera polaridad y retención cromatográfica | y es detectable mediante HPLC con detección UV y confirmable por LC-MS y espectroscopía NMR para asignación de estructura. Su presencia suele originarse por rutas de degradación o reacciones secundarias durante la síntesis y el almacenamiento | por lo que las estrategias de control incluyen métodos indicativos de estabilidad | límites conforme a ICH y pruebas de limpieza analítica para garantizar calidad y seguridad del lote.
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