Prednisolone-21-ethylcarbonate (CAS 2205-88-1) | conocido como Prednicarbate EP Impurity D | es una impureza derivada por esterificación en la posición 21 del núcleo de prednisolona | consistente en un grupo etilcarbonato. Su identificación y cuantificación son críticas en el control de calidad de prednicarbate | debido a su potencial para alterar el perfil de degradación y el ensayo del API. Se detecta y confirma mediante HPLC acoplado a espectrometría de masas y NMR | y se recomienda establecer límites conforme a ICH Q3A/B y procedimientos de liberación. El seguimiento de condiciones de síntesis | control de impurezas relacionadas y estudios de estabilidad minimizan su formación y riesgo regulatorio.
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