[Cyanocobalamin Reference Standard (Control 951) of the National Institute of Health Sciences].

A Kitajima, K Maekawa, K Yoshii, H Komatsu, T Tanimoto, S Okada
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Abstract

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).

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[国家卫生科学研究所氰钴胺参考标准(Control 951)]。
为编制《氰钴胺参考标准品(Control 951)》,对氰钴胺原料进行了检测。得到的分析数据如下:干燥损失1.8%;红外光谱,与JP氰钴胺参考标准(对照品936)相同;薄层色谱法,检出3种杂质;高效液相色谱(HPLC)检出8 ~ 9种杂质,估计杂质总量为1.6 +/- 0.13% (n = 4);用jpxii规定的分光光度法和高效液相色谱法分别测定了99.7%和100.4%。根据上述结果,该原料被批准为JP氰钴胺素参考标准品(Control 951)。
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