Kitajima A, Tagashira Y, Maekawa K, Yoshii K, Komatsu H, Tanimoto T, Okada S
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 1997(115):187-9.
The raw material for estradiol was examined for preparation of the "Estradiol Reference Standard (Control 961)" of National Institute of Health Sciences. Analytical data obtained were as follows: melting point, 179.1 degrees C; UV spectrum, lambda max = 281 nm; IR spectrum, the same as that of the Estradiol Reference Standard of National Institute of Health Sciences (Control 931); optical rotation, [alpha]20D = +79.5 degrees; thin-layer chromatography, one impurity was detected; high-performance liquid chromatography (HPLC), a trace amount of three impurities were detected; loss on drying, 3.17%; assay, 99.4% by UV spectrophotometry and 99.0% by HPLC. Based on the above results, the raw material was authorized as the Estradiol Reference Standard (Control 961) of National Institute of Health Sciences.
对雌二醇的原料进行了检测,以制备国立卫生科学研究所的“雌二醇参考标准品(对照品961)”。获得的分析数据如下:熔点,179.1℃;紫外光谱,λmax = 281nm;红外光谱,与国立卫生科学研究所的雌二醇参考标准品(对照品931)相同;旋光度,[α]20D = +79.5°;薄层色谱法,检测到一种杂质;高效液相色谱法(HPLC),检测到痕量的三种杂质;干燥失重,3.17%;含量测定,紫外分光光度法为99.4%,HPLC法为99.0%。根据上述结果,该原料被批准为国立卫生科学研究所的雌二醇参考标准品(对照品961)。