[Prednisolone Acetate Reference Standard (Control 901) of the National Institute of Hygienic Sciences].
Prednisolone Acetate Reference Standard (Control 901) for the Japanese Pharmacopoeia (JP RS) was prepared. The following analytical data were obtained: melting point 236 degrees C (decomposition); IR spectrum was same as that of JP RS of prednisolone acetate; absorptivity at 243 nm E1%lcm = 379; optical rotation [alpha]20D = +113.0 degrees; no impurity was detected by TLC, but a small amount of two impurities was found by HPLC analysis; assay by HPLC against the JP RS 100.2%. Based on the above results, this raw material was authorized as the Reference Standard of the National Institute of Hygienic Sciences.
H
H
Kakehi
H
H
Komatsu
M
M
Murai
S
S
Ishimitsu
S
S
Okada
D002851:Chromatography, High Pressure Liquid; D002855:Chromatography, Thin Layer; D006077:Government Agencies; D006920:Hygiene; D007564:Japan; D010602:Pharmacopoeias as Topic; D011239:Prednisolone / Q000031:analogs & derivatives* / Q000592:standards
C009935:prednisolone acetate; D011239:Prednisolone