Iwata M, Kawaguchi W, Maekawa K, Saito H, Tanimoto T, Okada S
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 1999(117):211-3.
The raw material of triamcinolone was examined for preparation of the "Triamcinolone Reference Standard (Control 981)". The analytical data obtained were: melting point, 246 degrees C (decomposition); UV spectrum, lambda max of 239 nm and specific absorbance in methanol at 289 nm of 394; IR spectrum, specific absorptions at 3462, 1716, 1659, 1615, 1604, 1132 and 1061 cm-1; optical rotation, [alpha]D20 = +69.7 degrees; high-performance liquid chromatography, five impurities detected and amount of each impurity estimated to be less than 0.6% and total amount of impurities less than 1.4%; loss on drying, 0.24%. Based on the above results, the raw material was authorized as the Triamcinolone Reference Standard (Control 981) of the National Institute of Health Sciences.
对曲安西龙的原料进行了检验,以制备“曲安西龙对照品(对照 981)”。获得的分析数据如下:熔点为 246℃(分解);紫外光谱,最大吸收波长为 239nm,在甲醇中 289nm 处的比吸收度为 394;红外光谱,在 3462、1716、1659、1615、1604、1132 和 1061cm-1 处有特征吸收;旋光度,[α]D20 = +69.7°;高效液相色谱法,检测到五种杂质,每种杂质的含量估计低于 0.6%,杂质总量低于 1.4%;干燥失重为 0.24%。基于上述结果,该原料被批准作为国立卫生科学研究所的曲安西龙对照品(对照 981)。