Okada S, Hiroshige R, Tanaka M, Murai M, Kimura T
Eisei Shikenjo Hokoku. 1990(108):150-2.
The raw material of hydrocortisone sodium phosphate was examined for the preparation of the "Hydrocortisone Sodium Phosphate Reference Standard". Analytical data obtained were as follows: pH, 8.2; optical rotation [alpha]D20, +124.1 degrees; Infrared spectrum, same as that of BP Reference Standard of Hydrocortisone Sodium Phosphate; thin-layer chromatography, no impurities were detected; high-performance liquid chromatography (HPLC), 2 kinds of small amount of impurities were detected; assay, 99.2% by the enzyme method and 99.9% by the HPLC method in terms of the BP Reference Standard. Based on the above results, this raw material was authorized to be the Reference Standard of the National Institute of Hygienic Sciences.
对磷酸氢化可的松原料进行了检验，以制备“磷酸氢化可的松对照品”。获得的分析数据如下：pH值8.2；旋光度[α]D20，+124.1度；红外光谱，与英国药典磷酸氢化可的松对照品相同；薄层色谱法，未检测到杂质；高效液相色谱法（HPLC），检测到2种少量杂质；含量测定，以英国药典对照品计，酶法为99.2%，HPLC法为99.9%。基于上述结果，该原料被批准作为国立卫生科学研究所的对照品。
