Kitajima A, Yoshii K, Komatsu H, Ishimitsu S, Okada S
Eisei Shikenjo Hokoku. 1994(112):167-9.
Raw dexamethasone material was tested for preparation of the "Dexamethasone Reference Standard (Control 931)". Analytical data obtained were as follows: melting point, 245.1 degrees C (decomposition); infrared spectrum, the same as that of the JP Dexamethasone Reference Standard; optical rotation, -alpha-20D = + 76.75 degrees; thin-layer chromatography, two impurities were detected; high-performance liquid chromatography (HPLC), one impurity was detected; loss on drying, 0.14%; assay result, 99.4% by HPLC. Based on the above findings, the raw material was authorized as the JP Dexamethasone Reference Standard (Control 931).
对原料地塞米松进行了“地塞米松对照品（对照931）”的制备测试。获得的分析数据如下：熔点，245.1℃（分解）；红外光谱，与日本药典地塞米松对照品相同；旋光度，-α-20D = + 76.75°；薄层色谱法，检测到两种杂质；高效液相色谱法（HPLC），检测到一种杂质；干燥失重，0.14%；含量测定结果，HPLC法为99.4%。基于上述结果，该原料被批准为日本药典地塞米松对照品（对照931）。
