Okada S, Hiroshige R, Tanaka M, Murai M, Kimura T
Eisei Shikenjo Hokoku. 1990(108):141-4.
The raw material of betamethasone sodium phosphate was examined for preparation of the "Betamethasone Sodium Phosphate Reference Standard". Analytical results for the sample were as follows: pH 7.90; optical rotation + 100.5 degrees; IR spectrum the same as USP Reference Standard of Betamethasone Sodium Phosphate; TLC indicated no impurities, but 5 kinds of impurities were detected in small amounts by HPLC; water content 14.7%; assay 100.2% by HPLC. Based on the above results, this raw material was authorized to be the Reference Standard of the National Institute of Hygienic Sciences.
对倍他米松磷酸钠原料药进行检测，以制备“倍他米松磷酸钠对照品”。该样品的分析结果如下：pH值7.90；旋光度+100.5度；红外光谱与美国药典倍他米松磷酸钠对照品相同；薄层色谱法表明无杂质，但高效液相色谱法检测到有5种少量杂质；含水量14.7%；高效液相色谱法测定含量为100.2%。基于上述结果，该原料药被批准为国家卫生科学研究所对照品。
