Impureza diastereomérica de Sacubitril SBT representa una variante estereoquímica que puede formarse durante la síntesis o el almacenamiento | afectando la pureza y el perfil de calidad del lote; esta impureza presenta propiedades cromatográficas y espectrales distintivas que requieren técnicas analíticas específicas para su identificación y cuantificación | tales como HPLC quiral | LC-MS/MS | RMN y estudios de estabilidad forzada. El control se logra mediante la optimización de condiciones de reacción | pasos de purificación y parámetros de acondicionamiento | junto con la definición de límites de aceptación y procedimientos de liberación | y su caracterización completa es clave para evaluar riesgos toxicológicos potenciales y cumplir requisitos regulatorios.
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