Dienogest EP Impurity A (CAS 86153-39-1) | denominado también 11-hidroxi dienogest y 2-((8S | 13S | 14S | 17R)-11 | 17-dihidroxy-13-metyl-3-oxo-2 | 3 | 6 | 7 | 8 | 11 | 12 | 13 | 14 | 15 | 16 | 17-dodecahydro-1H-cyclopenta[a]phenanthren-17-yl)acetonitrile | es una impureza esteroidal derivada de la oxidación en la posición C11 que altera la polaridad y el perfil de retención frente al compuesto de referencia. Presenta grupos hidroxilo y una función cetona en C3 | lo que modifica su comportamiento en cromatografía líquida y su patrón de fragmentación en espectrometría de masas. El control cuantitativo mediante HPLC-UV y LC-MS/MS | junto con caracterización por RMN y pruebas de estabilidad | es esencial para cumplimiento de especificaciones EP y evaluación de riesgo en el proceso sintético.
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