[Cholecalciferol reference standard (Control 941) of the National Institute of Health Sciences].

Abstract

The raw material for cholecalciferol was tested for preparation of the "Cholecalciferol Reference Standard (Control 941)". Analytical data obtained were as follows: melting point, 88.5 degrees C; UV and infrared spectra, the same as those for JP Cholecalciferol Reference Standard (Control 923), respectively; specific absorbance at 265 nm E1%1cm = 471; optical rotation, [alpha]20D = +107.3 degrees; thin-layer chromatography and high-performance liquid chromatography (HPLC), no impurities were detected, respectively; assay, 101.3% by HPLC. Based on the above results, the candidate raw material was authorized as the Japanese Pharmacopoeia Reference Standard (Control 941).