Kitajima A, Tanimoto T, Okada S
Eisei Shikenjo Hokoku. 1995(113):111-3.
The raw material for betamethasone valerate was tested for preparation of the "Betamethasone Valerate Reference Standard (Control 941)". Analytical data obtained were as follows: melting point, 194.3 degrees C (decomposition); UV and infrared spectra, the same as those for JP Betamethasone Valerate Reference Standard (Control 844); optical rotation, [alpha]20D = +79.4 degrees; thin-layer chromatography and high-performance liquid chromatography (HPLC), no impurities were detected; assay, 100.0% by HPLC. Based on the above results, the candidate material was authorized as the JP Betamethasone Valerate Reference Standard (Control 941).
对戊酸倍他米松的原料进行检测，以制备“戊酸倍他米松对照品（对照941）”。获得的分析数据如下：熔点为194.3℃（分解）；紫外光谱和红外光谱与日本药局方戊酸倍他米松对照品（对照844）相同；比旋度，[α]20D = +79.4°；薄层色谱和高效液相色谱（HPLC）未检测到杂质；含量测定，HPLC法测定为100.0%。基于上述结果，该候选原料被批准为日本药局方戊酸倍他米松对照品（对照941）。
