Murakami Miho, Morita Yukiko, Koide Tatsuo, Saito Hiroyuki, Tanimoto Tsuyoshi
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2003(121):68-70.
The raw material of tocopherol acetate was examined for the preparation of the "Tocopherol Acetate Reference Standard (Control 021)", The analytical data obtained were: UV spectrum, lambda max of 278.5 and 284.8 nm and specific absorbance in ethanol at 284 nm = 42.9; IR spectrum, same as that of the Tocopherol Acetate Reference Standard (Control 001); thin-layer chromatography, no impurities were detected until 50 micrograms; high-performance liquid chromatography, total amount of impurities estimated to be less than 0.6%. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Tocopherol Acetate Reference Standard (Control 021) of the National Institute of Health Sciences.
对生育酚醋酸酯原料进行了检验,以制备“生育酚醋酸酯对照品(对照 021)”。获得的分析数据如下:紫外光谱,最大吸收波长为 278.5 和 284.8 nm,在乙醇中 284 nm 处的比吸收度 = 42.9;红外光谱,与生育酚醋酸酯对照品(对照 001)相同;薄层色谱法,直至 50 微克均未检测到杂质;高效液相色谱法,杂质总量估计小于 0.6%。基于上述结果,该原料被批准作为国立卫生科学研究所的日本药典生育酚醋酸酯对照品(对照 021)。