Murakami Miho, Morita Yukiko, Koide Tatsuo, Saito Hiroyuki, Tanimoto Tsuyoshi
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2003(121):62-4.
The raw material of estrone acetate was examined for the preparation of the "Estrone Reference Standard (Control 021)", The analytical data obtained were: UV spectrum, lambda max of 281 nm and specific absorbance in ethanol at 281 nm = 76.1; Melting point, 261.6 degrees C; IR spectrum, exhibited the specific absorptions at 3345, 2867, 1720, 1499 and 1055 cm-1; thin-layer chromatography, 2 impurities were detected at 100 and 200 micrograms; high-performance liquid chromatography, total amount of impurities estimated to be less than 0.3%. Based on the above results, the raw material was authorized as Estrone Reference Standard (Control 021) of the National Institute of Health Sciences.
对醋酸雌酮原料进行了检查,以制备“雌酮对照品(对照021)”。获得的分析数据如下:紫外光谱,最大吸收波长为281nm,在乙醇中281nm处的比吸收度为76.1;熔点,261.6℃;红外光谱,在3345、2867、1720、1499和1055cm-1处有特定吸收;薄层色谱法,检测到100和200微克的2种杂质;高效液相色谱法,杂质总量估计小于0.3%。基于上述结果,该原料被批准为国立卫生科学研究所的雌酮对照品(对照021)。