Kitajima A, Maekawa K, Yoshii K, Komatsu H, Tanimoto T
Eisei Shikenjo Hokoku. 1995(113):107-10.
The raw material for prednisolone acetate was tested for preparation of the "Prednisolone Acetate Reference Standard (Control 941)". Analytical data obtained were as follows: melting point, 237.5 degrees C (decomposition); UV and infrared spectra, the same as those for JP Prednisolone Acetate Reference Standard (Control 903), respectively; specific absorbance at lambda max E1%1cm = 379; optical rotation, [alpha]20D = +115.2 degrees; thin-layer chromatography and high-performance liquid chromatography (HPLC), no impurities were detected, respectively; assay, 100.8% by HPLC. Based on the above results, the candidate material was authorized as the Japanese Pharmacopoeia Reference Standard (Control 941).
对醋酸泼尼松龙的原料进行了检测，以制备“醋酸泼尼松龙对照品（对照品941）”。获得的分析数据如下：熔点，237.5℃（分解）；紫外光谱和红外光谱分别与日本药典醋酸泼尼松龙对照品（对照品903）相同；最大吸收波长处的比吸光度E1%1cm = 379；旋光度，[α]20D = +115.2°；薄层色谱法和高效液相色谱法（HPLC）分别未检测到杂质；含量测定，HPLC法测定为100.8%。根据上述结果，该候选原料被批准为日本药典对照品（对照品941）。
