Kitajima A, Iwata M, Maekawa K, Saito H, Tanimoto T, Okada S
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 1998(116):177-9.
The raw material of tocopherol acetate was examined for the preparation of the "Tocopherol Acetate Reference Standard (Control 971)". Analytical data obtained were as follows: infrared spectrum, the same as that of the Tocopherol Acetate Reference Standard (Control 941); specific absorbance, E1 cm 1% (284 nm) = 43.0; thin-layer chromatography, no impurities were detected until 50.0 micrograms of the loaded raw material; high-performance liquid chromatography (HPLC), one impurity was detected and the amount was estimated to be about 0.68%; assay by HPLC, 100.2%. Based on the above results, the raw material was authorized as the Tocopherol Acetate Reference Standard (Control 971) of National Institute of Health Sciences.
对用于制备“生育酚醋酸酯对照品（对照 971）”的生育酚醋酸酯原料进行了检验。获得的分析数据如下：红外光谱，与生育酚醋酸酯对照品（对照 941）相同；比吸光系数，E1 cm 1%（284 nm）= 43.0；薄层色谱法，直至点样 50.0 微克原料均未检测到杂质；高效液相色谱法（HPLC），检测到一种杂质，含量估计约为 0.68%；采用 HPLC 法测定含量为 100.2%。基于上述结果，该原料被批准作为国立卫生科学研究所的生育酚醋酸酯对照品（对照 971）。
