Kitajima A, Yoshii K, Komatsu H, Ishimitsu S, Okada S
Eisei Shikenjo Hokoku. 1994(112):192-5.
Raw thiamine hydrochloride material was tested for preparation of the "Thiamine Hydrochloride Reference Standard (Control 931)". Analytical data obtained were as follows: melting point, 242.7 degrees C (decomposition); infrared spectrum, the same as that of the JP Thiamine Hydrochloride Reference Standard; thin-layer chromatography, one impurity was detected; high-performance liquid chromatography (HPLC), a trace amount of one impurity was detected; assay results, 100.4% by UV spectrophotometry and 100.0% by HPLC, respectively. Based on the above findings, the raw material was authorized as the JP Thiamine Hydrochloride Reference Standard (Control 931).
对盐酸硫胺素原料药进行了“盐酸硫胺素对照品（对照 931）”的制备测试。获得的分析数据如下：熔点，242.7℃（分解）；红外光谱，与日本药典盐酸硫胺素对照品相同；薄层色谱法，检测到一种杂质；高效液相色谱法（HPLC），检测到痕量的一种杂质；含量测定结果，分别采用紫外分光光度法为 100.4%，采用 HPLC 法为 100.0%。基于上述结果，该原料药被批准为日本药典盐酸硫胺素对照品（对照 931）。
