Methylprednisolone EP Impurity D (hydrous) es una impureza hidratada asociada al activo que puede formarse por incorporación de agua durante síntesis | purificación o almacenamiento. Se caracteriza por diferencias cristalográficas y perfiles termales frente al material anhidro | afectando potencialmente la pureza y la estabilidad farmacéutica. Su identificación y cuantificación requieren métodos indicativos de estabilidad validados | típicamente cromatografía líquida de alta resolución (HPLC) con confirmación por espectrometría de masas (LC-MS) y resonancia magnética nuclear para establecer estructura y grado de hidratación. El control se logra mediante especificaciones basadas en la Farmacopea Europea | estudios de degradación forzada y prácticas de conservación anhidra en fabricación.
Referencias
Liu, D., Ahmet, A., Ward, L., Krishnamoorthy, P., Mandelcorn, E. D., Leigh, R., … Kim, H. (2013). A practical guide to the monitoring and management of the complications of systemic corticosteroid therapy. Allergy, Asthma & Clinical Immunology, 9(1). https://doi.org/10.1186/1710-1492-9-30 ‌
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