Kitajima A, Maekawa K, Yoshii K, Komatsu H, Tanimoto T, Okada S
Eisei Shikenjo Hokoku. 1996(114):113-5.
The raw material of digitoxin was tested for preparation of the "Digitoxin Reference Standard (Control 951)". Analytical data obtained were as follows: loss on drying, 0.0%; infrared spectrum, the same as that of the JP Digitoxin Reference Standard (Control 845); thin-layer chromatography, no impurity was detected; high-performance liquid chromatography (HPLC), two kinds of impurities were detected and the total amount was estimated to be 0.16 +/- 0.01% (n = 3); assay, 99.0% by HPLC. Based on the above results, the raw material was authorized as the JP Digitoxin Reference Standard (Control 951).
对洋地黄毒苷原料进行了检测，以制备“洋地黄毒苷对照品（对照951）”。获得的分析数据如下：干燥失重，0.0%；红外光谱，与日本药典洋地黄毒苷对照品（对照845）相同；薄层色谱法，未检测到杂质；高效液相色谱法（HPLC），检测到两种杂质，总量估计为0.16±0.01%（n = 3）；含量测定，通过HPLC法测定为99.0%。基于上述结果，该原料被批准为日本药典洋地黄毒苷对照品（对照951）。
