Dienogest EP Impurity M (CAS 98149-13-4) es una impureza estructuralmente relacionada con el compuesto principal | caracterizada por la presencia de un átomo de bromo | un grupo hidroxilo en posición 17α | una cetona en C3 y un grupo nitrilo en la cadena 21 | lo que la define como (17α)-4-bromo-17-hidroxi-3-oxo-19-norpregna-4 | 9-dieno-21-nitrilo. Su identificación y cuantificación requieren metodologías analíticas robustas como HPLC con detección UV | LC MS y RMN para asignación de estructura y estereoquímica. Esta impureza puede originarse por reacciones secundarias en síntesis o por degradación y exige control de pureza | límites especificados y estudios de estabilidad para cumplir la normativa de la Farmacopea Europea y asegurar la calidad del producto final.
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