国家卫生科学研究所氰钴胺参考标准(Control 931)。

A Kitajima, K Yoshii, H Komatsu, S Ishimitsu, S Okada
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引用次数: 0

摘要

为制备《氰钴胺参考标准品(对照品931)》,对氰钴胺原料进行了检测。得到的分析数据如下:干燥损失4.2%;红外光谱,与JP氰钴胺参考标准(对照品901)相同;薄层色谱法,检出4种杂质;高效液相色谱法检出7 ~ 8种杂质,但杂质总量仅为1.0 +/- 0.52% (n = 5);测定结果:JP 12中分光光度法100.6%,高效液相色谱法99.7%。基于上述发现,该原料被批准为JP氰钴胺参考标准品(Control 931)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[The Cyanocobalamin Reference Standard (Control 931) of the National Institute of Health Sciences].

Raw cyanocobalamin material was tested for preparation of the "Cyanocobalamin Reference Standard (Control 931)". Analytical data obtained were as follows: loss on drying, 4.2%; infrared spectrum, the same as that of the JP Cyanocobalamin Reference Standard (Control 901); thin-layer chromatography, four impurities were detected; high-performance liquid chromatography (HPLC), seven to eight kinds of impurities were detected, but the total amount of impurities was only 1.0 +/- 0.52% (n = 5); assay results, 100.6% by spectrophotometry in the JP XII and 99.7% by HPLC. Based on the above findings, the raw material was authorized as the JP Cyanocobalamin Reference Standard (Control 931).

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