Impureza Methylene Calcitriol (CAS 1428946-52-4) | identificada como (1R | 3R | 5Z)-2 | 4-Bis(methylene)-5-[(2E)-2-[(1R | 3aS | 7aR)-octahydro-1-[(1R)-5-hydroxy-1 | 5-dimethylhexyl]-7a-methyl-4H-inden-4-ylidene]ethylidene]-1 | 3-cyclohexanediol | presenta un perfil crítico en procesos de síntesis y purificación. Su presencia puede afectar la potencia y la estabilidad del lote y requiere cuantificación mediante HPLC con detección UV o LC-MS/MS para límite de detección sub-ppm. Se recomienda caracterización complementaria por RMN y espectrometría de masas para confirmar la estructura | estudio de solubilidad y pruebas de degradación forzadas para establecer especificaciones y límites de aceptación. Implementar controles de proceso y etapas adicionales de purificación para minimizar su nivel en el producto final.
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