Iwata M, Maekawa K, Saito H, Tanimoto T, Okada S
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 1999(117):208-10.
The raw material of triamcinolone acetonide was examined for preparation of the "Triamcinolone Acetonide Reference Standard (Control 981)". The analytical data obtained were: melting point, 289 degrees C (decomposition); UV spectrum, lambda max of 238 nm; IR spectrum, same as that of the Triamcinolone Acetonide Reference Standard (Control 834); optical rotation, [alpha]D20 = +106.8 degrees; thin-layer chromatography, no impurities detected; high-performance liquid chromatography, total amount of impurities less than 0.4%; loss on drying, 1.3%; assay by HPLC, 100.1%. Based on the above results, the raw material was authorized as the Triamcinolone Acetonide Reference Standard (Control 981) of the National Institute of Health Sciences.
对曲安奈德原料药进行检测以制备“曲安奈德对照品（对照 981）”。获得的分析数据如下：熔点，289℃（分解）；紫外光谱，最大吸收波长为 238nm；红外光谱，与曲安奈德对照品（对照 834）相同；旋光度，[α]D20 = +106.8°；薄层色谱法，未检测到杂质；高效液相色谱法，杂质总量小于 0.4%；干燥失重，1.3%；采用高效液相色谱法测定含量，为 100.1%。基于上述结果，该原料药被批准为国立卫生科学研究所的曲安奈德对照品（对照 981）。
