Tanimoto T, Iwata M, Kitajima A, Maekawa K, Saito H, Okada S
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 1998(116):170-3.
The "Retinol Acetate Reference Standard (Control 971)" and "Retinol Palmitate Reference Standard (Control 971)" of National Institute of Health Sciences using the assay of vitamin A ester were prepared. The proposed materials were evaluated in collaboration with four laboratories. Analytical data obtained were as follows. 1) The purities of retinol acetate and retinol palmitate measured by HPLC were 99.9 +/- 0.06% and 94.5 +/- 0.06%, respectively. 2) ultraviolet spectrum of retinol acetate and retinol palmitate showed the lambda max at 326-327 nm. 3) The difference in relative extinction of retinol acetate and retinol palmitate at 300 nm, 310 nm, 320 nm, 330 nm, 340 nm and 350 nm are within the range provided in JPXIII. 4) The contents of retinol acetate and retinol palmitate were 52,000 IU/g and 52,200 IU/g, respectively. Based on the above results, these proposed materials were authorized to be the Reference Standards of the National Institute of Health Sciences.
采用维生素A酯测定法制备了国立卫生科学研究所的“醋酸视黄酯参考标准品(对照品971)”和“棕榈酸视黄酯参考标准品(对照品971)”。与四个实验室合作对所提议的材料进行了评估。获得的分析数据如下:1)通过高效液相色谱法测定的醋酸视黄酯和棕榈酸视黄酯的纯度分别为99.9±0.06%和94.5±0.06%。2)醋酸视黄酯和棕榈酸视黄酯的紫外光谱在326 - 327nm处显示最大吸收波长。3)醋酸视黄酯和棕榈酸视黄酯在300nm、310nm、320nm、330nm、340nm和350nm处的相对消光差异在日本药典第十三版规定的范围内。4)醋酸视黄酯和棕榈酸视黄酯的含量分别为52,000IU/g和52,200IU/g。基于上述结果,这些提议的材料被批准为国立卫生科学研究所的参考标准品。