Cortisone Acetate Reference Standard (Control 921) of National Institute of Health Sciences

The raw material of cortisone acetate was tested for the preparation of "Cortisone Acetate Reference Standard (Control 921)". The quality of the raw material was examined and compared with the previous Cortisone Acetate Reference Standard (Control 743). Analytical data obtained were as follows: loss on drying, 0.06%; melting point, 245.9 degrees C (decomposition); optical rotation, [alpha]20D = +215.5 degrees; UV spectrum, lambda max = 239 nm and specific absorbance E 1%1 cm (239 nm) = 393; infrared spectrum, the same as that of the previous Reference Standard (Control 743); thin-layer chromatography, no impurities were detected up to 100 micrograms; high-performance liquid chromatography (HPLC), three impurities were detected; assay, 100.5% by HPLC. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Reference Standard (Control 921).