[Cholecalciferol Reference Standard (Control 031) of National Institute of Health Sciences]

The raw material of cholecalciferol was examined for the preparation of the "Cholecalsiferol Reference Standard (Control 031)", The analytical data obtained were: melting point, 86.3 degrees C; UV spectrum, lambda max of 264.6 nm and specific absorbance in ethanol at 265 nm = 483.6; IR spectrum, same as that of the cholecalciferol Reference Standard (Control 003); optical rotation [alpha]20(D) = 105.1 degrees; thin-layer chromatography, one impurity was detected at 50 micrograms; high-performance liquid chromatography, total amount of impurities estimated to be less than 0.04%. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Cholecalciferol Reference Standard (Control 031) of the National Institute of Health Sciences.