[Prednisolone acetate reference standard (Control 941) of the National Institute of Health Sciences].

Abstract

The raw material for prednisolone acetate was tested for preparation of the "Prednisolone Acetate Reference Standard (Control 941)". Analytical data obtained were as follows: melting point, 237.5 degrees C (decomposition); UV and infrared spectra, the same as those for JP Prednisolone Acetate Reference Standard (Control 903), respectively; specific absorbance at lambda max E1%1cm = 379; optical rotation, [alpha]20D = +115.2 degrees; thin-layer chromatography and high-performance liquid chromatography (HPLC), no impurities were detected, respectively; assay, 100.8% by HPLC. Based on the above results, the candidate material was authorized as the Japanese Pharmacopoeia Reference Standard (Control 941).