[Prednisolone Sodium Phosphate Reference Standard (Control 891) of National Institute of Hygienic Sciences].
The raw material of prednisolone sodium phosphate was examined for preparation of the "Prednizolone Sodium Phosphate Reference Standard". Analytical data obtained were as follows: pH 7.6; optical rotation [alpha]D25, +99.0 degrees; Infrared spectrum, same as that of BP Reference Standard; Thin-layer chromatography, 4 impurities were detected; high-performance liquid chromatography (HPLC), 7 kinds of impurities were detected; residual solvent, 0.76% (ethnol) and 0.23% (hexane); assay, 100.2% by the enzyme method and 99.7% 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.
Okada
S
S
Hiroshige
R
R
Tanaka
M
M
Murai
M
M
Kimura
T
T
D002851:Chromatography, High Pressure Liquid; D002855:Chromatography, Thin Layer; D006077:Government Agencies; D006854:Hydrocortisone / Q000031:analogs & derivatives* / Q000302:isolation & purification / Q000592:standards; D006920:Hygiene; D007564:Japan; D010602:Pharmacopoeias as Topic; D013055:Spectrophotometry, Infrared
C039803:hydrocortisone sodium phosphate; D006854:Hydrocortisone