Okada S, Hiroshige R, Tanaka M, Murai M, Kimura T
Eisei Shikenjo Hokoku. 1990(108):136-8.
The raw material of thiamine hydrochloride was examined for preparation of the "Thiamine Hydrochloride Reference Standard". Analytical results were as follows: melting point 242.7 degrees; pH 3.2 (1 g, water, 100 ml); IR spectrum the same as that of JP Reference Standard (Control: 841); one and two impurities detected by TLC and by HPLC analyses, respectively; assay by thiochrome method 100.3% and by HPLC 100.1% against the JP Reference Standard. Based on the results, the present raw material was authorized to be the Reference Standard of the National Institute of Hygienic Sciences.
对盐酸硫胺的原料进行了检验,以制备“盐酸硫胺参考标准品”。分析结果如下:熔点242.7℃;pH值3.2(1g,水,100ml);红外光谱与日本药典参考标准品相同(对照:841);分别通过薄层色谱法和高效液相色谱法检测到一种和两种杂质;硫色素法测定含量相对于日本药典参考标准品为100.3%,高效液相色谱法测定为100.1%。根据这些结果,本原料被批准作为国立卫生科学研究所的参考标准品。