Impureza de estriol 4 es un producto secundario identificado en el perfil de impurezas del estriol que puede generarse durante etapas de síntesis o por degradación química en almacenamiento. Su caracterización analítica incluye HPLC con detección UV | LC-MS para determinación de masa y RMN para confirmación estructural. La presencia de esta impureza puede afectar la pureza | estabilidad y cumplimiento de límites regulatorios | por lo que se recomienda establecer límites de especificación compatibles con ICH Q3A/Q3B y estrategias de control en proceso como optimización de condiciones de reacción | purificación y estudios forzados de degradación. Se requiere validación analítica y muestreo representativo para controlar su nivel en lote.
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