[Hydrocortisone Sodium Phosphate Reference Standard (Control 001) of National Institute of Health Sciences]

The raw material of hydrocortisone sodium phosphate was examined for the preparation of the "Hydrocortisone Sodium Phosphate Reference Standard (Control 001)". The analytical data obtained were: pH, 8.3: optical rotation, [alpha]D20 = +126.2 degrees; UV spectrum, lambda max of 248 nm and specific absorbance in water at 248 nm = 338.6; IR spectrum, same as that of the Hydrocortisone Sodium Phosphate Reference Standard (Control 891); free phosphoric acid, 0.2%; free hydrocortisone, 0.01%; thin-layer chromatography, no impurity was detected until 200 micrograms; high-performance liquid chromatography, total amount of impurities estimated to be less than 0.2%; residual solvent, 0.0% (acetone) and 0.02% (ethanol); loss on drying, 1.5%. Based on the above results, the raw material was authorized as the Hydrocortisone Sodium Phosphate Reference Standard (Control 001) of the National Institute of Health Sciences.