Estetrol (base libre) | CAS 15183-37-6 | identificada como Estra-1 | 3 | 5(10)-trieno-3 | 15 | 16 | 17-tetrol (15α | 16α | 17β) | es una impureza crítica que requiere control riguroso en materias primas y productos intermedios. Su perfil fisicoquímico y propiedades de solubilidad influyen en métodos analíticos como HPLC con detección UV y espectrometría de masas para identificación y cuantificación. Se recomienda validar límites de impurezas | establecer criterios de aceptación según ICH | y monitorizar estabilidad bajo estrés térmico | oxidativo y fotolítico. La cuantificación precisa y el establecimiento de procedimientos de purificación minimizan riesgos de lote y aseguran conformidad con especificaciones de calidad.
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