Prednisolone EP Impurity J (CAS 1807-14-3) | conocida también como 11-Deoxy Prednisolone | es una impureza estructuralmente relacionada con el núcleo glucocorticoide de la prednisolona que puede formarse durante la síntesis o por degradación. Su detección y control son esenciales en el aseguramiento de calidad; se caracteriza por espectrometría de masas y NMR que evidencian la desoxigenación en C11 y por un tiempo de retención reproducible en HPLC/LC-MS. La presencia de esta impureza puede alterar perfiles de estabilidad y especificaciones de lote | por lo que se recomienda su aislamiento como estándar | validación analítica y cumplimiento de los límites establecidos por la Farmacopea Europea.
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