[Ergocalciferol Reference Standard (Control 001) of National Institute of Health Sciences]

The raw material of ergocalciferol was examined for the preparation of "Ergocalciferol Reference Standard (Control 001)". Analytical data obtained were: melting point, 114.8 degrees C; UV and infrared spectra, the same as those of JP Ergocalciferol Reference Standard (Control 971); specific absorbance, E1ca1% = 471(265 nm); optical rotation, [alpha]D20 = +102.4 degrees; thin-layer chromatography, no impurities were detected until 100 micrograms; high-performance liquid chromatography (HPLC), total amount of impurities estimated to be less than 0.1%. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Ergocalciferol Reference Standard (Control 001).