Prednisolone reference standard (Control 911) of the National Institute of Hygienic Sciences
Izumi, W.; Murai, M.; Komatsu, H.; Ishimitsu, S.; Okada, S.
Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences 1992(110): 113-116
1992
ISSN/ISBN: 0077-4715 PMID: 1364419 Document Number: 392566
Prednisolone was tested for preparation of the "Prednisolone Reference Standard (Control 911)". The quality of raw material was examined and compared with the previous Reference Standard (Control 872). Analytical data obtained were as follows: loss on drying, 0.10%; melting point, 233.2 degrees C (decomposition); optical rotation, ɑ20D+98.77 degrees; UV spectrum, lambda max = 243nm; absorptivity, E1%1cm (243nm) = 413.5; IR spectrum, 1711, 1612, 1110, 888cm-1; one impurity was detected by thin-layer chromatography and high-performance liquid chromatography (HPLC), respectively; assay, 100.1% by HPLC. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Standard (Control 911).