Kakehi H, Komatsu H, Murai M, Ishimitsu S, Okada S
Eisei Shikenjo Hokoku. 1991(109):142-5.
Prednisolone Acetate Reference Standard (Control 901) for the Japanese Pharmacopoeia (JP RS) was prepared. The following analytical data were obtained: melting point 236 degrees C (decomposition); IR spectrum was same as that of JP RS of prednisolone acetate; absorptivity at 243 nm E1%lcm = 379; optical rotation [alpha]20D = +113.0 degrees; no impurity was detected by TLC, but a small amount of two impurities was found by HPLC analysis; assay by HPLC against the JP RS 100.2%. Based on the above results, this raw material was authorized as the Reference Standard of the National Institute of Hygienic Sciences.
制备了日本药局方（JP RS）的醋酸泼尼松龙对照品（对照品901）。获得以下分析数据：熔点236℃（分解）；红外光谱与醋酸泼尼松龙JP RS的红外光谱相同；在243nm处的吸光度E1%lcm = 379；旋光度[α]20D = +113.0°；薄层色谱法未检测到杂质，但高效液相色谱分析发现有少量两种杂质；用高效液相色谱法相对于JP RS进行含量测定为100.2%。基于上述结果，该原料被批准为国立卫生科学研究所的对照品。
