Ibuprofen EP Impurity R (CAS 102120-87-6) es una impureza hidrofóbica derivada del ibuprofeno | químicamente identificada como 1 | 1-di(4-isobutylphenyl)ethane y también referida como 1 | 1-Bis(p-isobutylphenyl)ethane o 4 | 4′-(ethane-1 | 1-diyl)bis(isobutylbenzene). Su perfil analítico incluye alta masa molecular | baja solubilidad en medios polares y comportamiento cromatográfico retardado | por lo que se monitoriza por HPLC | GC-MS y espectrometría de masas para control de calidad. El control cuantitativo y el establecimiento de límites de aceptación son críticos para cumplimiento farmacéutico | estabilidad del lote y trazabilidad | y se requieren estándares de referencia y métodos validados para su identificación y cuantificación.
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