Kitajima A, Maekawa K, Yoshii K, Komatsu H, Tanimoto T, Okada S
Eisei Shikenjo Hokoku. 1996(114):122-4.
The raw material of cyanocobalamin was tested for preparation of the "Cyanocobalamin Reference Standard (Control 951)". Analytical data obtained are as follows: loss on drying, 1.8%; infrared spectrum, the same as that of the JP Cyanocobalamin Reference Standard (Control 936); thin-layer chromatography, three impurities were detected; high-performance liquid chromatography (HPLC), eight to nine kinds of impurities were detected and the total amount of impurities was estimated to be 1.6 +/- 0.13% (n = 4); assay, 99.7% by spectrophotometry specified in the JP XII and 100.4% by HPLC, respectively. Based on the above results, the raw material was authorized as the JP Cyanocobalamin Reference Standard (Control 951).
对用于制备“氰钴胺参考标准品（对照 951）”的氰钴胺原料进行了检测。获得的分析数据如下：干燥失重 1.8%；红外光谱，与日本药典氰钴胺参考标准品（对照 936）相同；薄层色谱法，检测到三种杂质；高效液相色谱法（HPLC），检测到八至九种杂质，杂质总量估计为 1.6±0.13%（n = 4）；含量测定，分别采用日本药典 XII 中规定的分光光度法为 99.7%，HPLC 法为 100.4%。基于上述结果，该原料被批准作为日本药典氰钴胺参考标准品（对照 951）。
