Tanaka M, Murai M, Kimura T, Okada S
Eisei Shikenjo Hokoku. 1990(108):166-9.
Cyanocobalamin was tested for preparation on the "Cyanocobalamin Reference Standard (Control 891)". Analytical data obtained were as follows: loss on drying, 9.77%; infrared spectrum, same as that of the Cyanocobalamin Reference Standard (Control 871); thin-layer chromatography, five contaminants were detected; high-performance liquid chromatography, nine contaminants were detected; assay, 100.00% by JP XI method and 99.79% by HPLC method in terms of the JP Reference Standard (Control 871), respectively. On the basis of the above results, this material was authorized as the Japanese Pharmacopoeia Standard (Control 891).
对氰钴胺进行了以“氰钴胺参比标准品（对照品891）”为标准的制备测试。获得的分析数据如下：干燥失重9.77%；红外光谱，与氰钴胺参比标准品（对照品871）相同；薄层色谱法，检测到5种杂质；高效液相色谱法，检测到9种杂质；含量测定，按日本药局方第十一版方法为100.00%，按高效液相色谱法以日本药局方参比标准品（对照品871）计为99.79%。基于上述结果，该物质被批准为日本药局方标准品（对照品891）。
