Okada S, Hiroshige R, Tanaka M, Murai M, Kimura T
Eisei Shikenjo Hokoku. 1990(108):153-5.
The raw material of prednisolone sodium phosphate was examined for preparation of the "Prednizolone Sodium Phosphate Reference Standard". Analytical data obtained were as follows: pH 7.6; optical rotation [alpha]D25, +99.0 degrees; Infrared spectrum, same as that of BP Reference Standard; Thin-layer chromatography, 4 impurities were detected; high-performance liquid chromatography (HPLC), 7 kinds of impurities were detected; residual solvent, 0.76% (ethnol) and 0.23% (hexane); assay, 100.2% by the enzyme method and 99.7% 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.
对泼尼松龙磷酸钠原料进行了检验，以制备“泼尼松龙磷酸钠标准品”。获得的分析数据如下：pH值7.6；旋光度[α]D25，+99.0度；红外光谱，与英国药典标准品相同；薄层色谱法，检测到4种杂质；高效液相色谱法（HPLC），检测到7种杂质；残留溶剂，乙醇0.76%，己烷0.23%；按酶法测定含量为100.2%，按HPLC法以英国药典标准品计为99.7%。基于上述结果，该原料被批准作为国立卫生科学研究所的标准品。
