Losartan Cum-Alcohol (CAS 852357-69-8) es una impureza relevante en el perfil de calidad del losartán que requiere control riguroso. Su identificación y cuantificación se realizan mediante HPLC y LC-MS para determinar retención | masa exacta y abundancia relativa. Se evalúa su origen por reacciones de alcoholización durante síntesis o degradación y su impacto sobre estabilidad | pureza y potencia del lote. Los métodos analíticos validados establecen límites de aceptación | criterios de resolución y recuperación para cumplimiento regulatorio. Monitoreo periódico y estudios de forzado ayudan a definir estrategias de mitigación y asegurar que los niveles residuales permanezcan dentro de especificaciones.
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