Impureza de cetirizina éster de sorbitol en forma de sal HCl | constituida por una mezcla de diastereómeros | que representa una variación estereoquímica crítica con impacto en la pureza del API y en los perfiles analíticos; su presencia puede provocar picos adicionales o solapados en cromatogramas HPLC y requiere métodos validados como HPLC de fase inversa | LC-MS y técnicas quirales para identificación y cuantificación. La heterogeneidad diastereomérica puede afectar estabilidad y comportamiento durante purificación | por lo que es esencial el control en síntesis | purificación y formulación | así como el establecimiento de límites en especificaciones y estudios de estabilidad para cumplimiento regulatorio.
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