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

The raw material of hydrocortisone acetate was examined for preparation of the "Hydrocortisone Acetate Reference Standard". Analytical results were as follows: E1%1cm (242 nm) 403; IR spectrum indicates specific absorption at 3424, 1745, 1721, 1630, and 1374 cm-1; optical rotation +164.4 degrees (in dioxane); melting point 219.5 degrees (decomposition); loss on drying 0.16%; TLC and HPLC analyses indicated one and three impurities, respectively; assay by HPLC was 99.7% against the previous Reference Standard. Based on the results, the present raw material was authorized to be the Reference Standard of the National Institute of Hygienic Sciences.