[Prednisolone Reference Standard (Control 971) of National Institute of Health Sciences].

The raw material of prednisolone was examined for the preparation of the "Prednisolone Reference Standard (Control 971)". Analytical data obtained were as follows: melting point, 238.4 degrees C (decomposition); infrared spectrum, the same as that of the Prednisolone Reference Standard (Control 911); UV spectrum, lambda max = 243 nm; specific absorbance, E1 cm 1% (243 nm) = 414.8; loss on drying, 0.06%; thin-layer chromatography, one impurity was detected; high-performance liquid chromatography (HPLC), 4 to 5 impurities were detected and the total amount was estimated to be about 0.51%; assay by HPLC, 100.6%. Based on the above results, the raw material was authorized as the Prednisolone Reference Standard (Control 971) of National Institute of Health Sciences.