Prednisolone Inhouse Impurity D (11β-Hydroxyboldione) | CAS 898-84-0 | es una impureza relacionada del prednisolona caracterizada por la sustitución hidroxilo en la posición 11β. Se origina típicamente por oxidación o hidroxilación durante la síntesis | procesos de purificación o estudios de estabilidad y presenta mayor polaridad que el compuesto parental | lo que modifica su retención cromatográfica. Su identificación y cuantificación se efectúan mediante HPLC con detección UV y LC-MS para confirmación de masa | complementadas por RMN para verificación estructural. El control rutinario y el establecimiento de límites según guías ICH son esenciales para asegurar la calidad | estabilidad y seguridad del producto.
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