Methyl 4-(2-(1 | 3-dioxoisoindolin-2-yl)ethoxy)-3-oxobutanoate (CAS 111429-90-4) | conocido también como Amlodipine Impurity 10 | es una impureza de proceso caracterizada por un núcleo isoindolinoftalimida unido a un fragmento éster cetona. Su perfil químico sugiere sensibilidad a hidrólisis y a reacciones de transesterificación bajo condiciones acuosas o básicas | lo que favorece su formación durante etapas de síntesis y purificación. Se recomienda su identificación y cuantificación mediante HPLC con detección UV | LC-MS y confirmación por RMN. El control en procesos y el muestreo dirigido son esenciales para cumplir requisitos regulatorios y garantizar consistencia del perfil de impurezas.
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