Izumi W, Komatsu H, Ishimitsu S, Okada S
Eisei Shikenjo Hokoku. 1992(110):107-9.
The raw material of pyridoxine hydrochloride was examined for preparation of the "Pyridoxine Hydrochloride Reference Standard". Analytical data obtained were as follows: loss on drying, 0.00%; pH, 2.87; melting point, 204.6 degrees C (decomposition); infrared spectrum, same as Pyridoxine Hydrochloride Reference Standard (Control 879); thin-layer chromatography, nonimpurities were detected; assay, 100.0% by non-aqueous titration and 100.0% by UV spectrophotometry. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Standard (Control 911).
对盐酸吡哆醇原料进行了检验,以制备“盐酸吡哆醇对照品”。获得的分析数据如下:干燥失重,0.00%;pH值,2.87;熔点,204.6℃(分解);红外光谱,与盐酸吡哆醇对照品(对照879)相同;薄层色谱法,未检测到杂质;含量测定,非水滴定法为100.0%,紫外分光光度法为100.0%。基于上述结果,该原料被批准为日本药典标准(对照911)。