Murakami Miho, Morita Yukiko, Koide Tatsuo, Saito Hiroyuki, Tanimoto Tsuyoshi
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2003(121):71-3.
The raw material of ergocalciferol was examined for the preparation of the "Ergocalsiferol Reference Standard (Control 031)", The analytical data obtained were: melting point, 114.5 degrees C; UV spectrum, lambda max of 264.8 nm and specific absorbance in ethanol at 265 nm = 474.7; IR spectrum, same as that of the Ergocalciferol Reference Standard (Control 003); optical rotation, [alpha]20(D) = +104.6 degrees ; thin-layer chromatography, two impurities were detected at 50 micrograms; high-performance liquid chromatography, total amount of impurities estimated to be less than 0.04%. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Ergocalciferol Reference Standard (Control 031) of the National Institute of Health Sciences.
对骨化醇原料进行了检验，以制备“骨化醇对照品（对照 031）”，获得的分析数据如下：熔点 114.5℃；紫外光谱，最大吸收波长 λmax 为 264.8nm，在乙醇中 265nm 处的比吸光度 = 474.7；红外光谱，与骨化醇对照品（对照 003）相同；旋光度，[α]20(D) = +104.6°；薄层色谱法，检测到 50μg 的两种杂质；高效液相色谱法，杂质总量估计小于 0.04%。基于上述结果，该原料被批准为国立卫生科学研究所的日本药典骨化醇对照品（对照 031）。
