Risedronic acid monosodium salt hemi(pentahydrate); Risedronate Sodium 2.5 Hydrate, P,P’-[1-Hydroxy-2-(3-pyridinyl)ethylidene]bisphosphonic acid sodium salt hydrate (2:2:5), [1-Hydroxy-2-(3-pyridinyl)ethylidene]bisphosphonic acid monosodium salt hydrate (2:5), Risedronic acid monosodium salt hemipentahydrate
Descripción
Impureza identificada en Prednisolone acetate CRS (CAS 52-21-1): Risedronic acid monosodium salt hemipentahydrate | caracterizada por alta polaridad y marcada afinidad por el agua que puede comprometer la pureza y el rendimiento del lote; su presencia se monitoriza mediante HPLC-UV con confirmación por LC-MS y análisis de fragmentación | y su cuantificación exige métodos validados de extracción y cromatografía en fase inversa o fases hidrofílicas; desde el punto de vista regulatorio debe incluirse en el perfil de impurezas con límites definidos a partir de estudios de estabilidad y toxicidad | y controlarse mediante especificaciones | pruebas de liberación y procedimientos de limpieza para minimizar su aporte.
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