Murai M, Kakehi H, Komatsu H, Ishimitsu S, Okada S
Eisei Shikenjo Hokoku. 1991(109):162-4.
The raw materials of retinol acetate and retinol palmitate were examined for the preparation of the "Retinol Acetate Reference Standard for Thin-layer Chromatography" and "Retinol Palmitate Reference Standard for Thin-layer Chromatography", respectively. Analytical data obtained were as follows: thin-layer chromatography, no impurities were detected in retinol acetate and one impurities was detected in retinol palmitate; The Rf values of retinol acetate and retinol palmitate were consistent with those of Reference Standards (Control 713), respectively; ultraviolet spectrum, lambda max = 326 approximately 327 nm; relative extinction, within the range reported in JPXI; weight variation of capsules, retinol acetate 224.0 +/- 15.5 mg (RSD 6.9%), retinol palmitate 222.0 +/- 13.8 mg (RSD 6.2%); assay, retinol acetate 57000 I.U./g, retinol palmitate 57000 I.U./g. Based on the above results, these raw materials were authorized to be the Reference Standards of the National Institute of Hygienic Sciences.
分别对醋酸视黄酯和棕榈酸视黄酯原料进行检验，以制备“薄层色谱用醋酸视黄酯对照品”和“薄层色谱用棕榈酸视黄酯对照品”。获得的分析数据如下：薄层色谱法，醋酸视黄酯中未检测到杂质，棕榈酸视黄酯中检测到一种杂质；醋酸视黄酯和棕榈酸视黄酯的比移值分别与对照品（对照713）一致；紫外光谱，最大吸收波长λmax = 326约327nm；相对消光系数，在日本药局方第十一版报告的范围内；胶囊装量差异，醋酸视黄酯224.0±15.5mg（相对标准偏差6.9%），棕榈酸视黄酯222.0±13.8mg（相对标准偏差6.2%）；含量测定，醋酸视黄酯57000IU/g，棕榈酸视黄酯57000IU/g。基于上述结果，这些原料被批准作为国立卫生科学研究所的对照品。
