Sacubitril Pyrrolidinone Impurity (CAS 2101222-51-7) es una impureza identificada en procesos de síntesis y formulación que afecta al perfil de pureza del principio activo. Su detección y cuantificación mediante HPLC con detección UV y confirmación por espectrometría de masas y RMN son críticas para el control de calidad. Presenta propiedades fisicoquímicas que pueden incluir solubilidad en disolventes orgánicos y formas cristalinas variables | requiriendo evaluación de estabilidad y degradación bajo estrés térmico y húmedo. La caracterización estructural y los límites de especificación permiten mitigar riesgos en la cadena de fabricación y asegurar consistencia analítica.
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