[Hydrocortisone Sodium Phosphate Reference Standard (Control 891) of National Institute of Hygienic Sciences]

The raw material of hydrocortisone sodium phosphate was examined for the preparation of the "Hydrocortisone Sodium Phosphate Reference Standard". Analytical data obtained were as follows: pH, 8.2; optical rotation [alpha]D20, +124.1 degrees; Infrared spectrum, same as that of BP Reference Standard of Hydrocortisone Sodium Phosphate; thin-layer chromatography, no impurities were detected; high-performance liquid chromatography (HPLC), 2 kinds of small amount of impurities were detected; assay, 99.2% by the enzyme method and 99.9% by the HPLC method in terms of the BP Reference Standard. Based on the above results, this raw material was authorized to be the Reference Standard of the National Institute of Hygienic Sciences.