[Prednisolone Reference Standard of National Institute of Hygienic Sciences]

Prednisolone reference standard for the Japanese Pharmacopoeia was prepared. The quality of raw material was examined and compared with the previous reference standard (Control 821). Analytical data for this substance were as follows: loss on drying, 0.04%; melting point, 234.1 degrees C (decomposition); optical rotation, [alpha] 20D + 100.2 degrees; UV spectrum, lambda max = 243 nm; absorptivity, E1%1cm (243 nm) = 415; IR spectrum, 1711, 1655, 1612, 1111, 899 cm-1; one impurity was detected by TLC and high-performance liquid chromatography (HPLC), respectively; assay by HPLC, 100.1%. Based on the above results, this raw material was authorized as the Reference Standard of National Institute of Hygienic Sciences.