| Abstract: | 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). |
