[The Alprostajil Reference Standard (Control 921) of the National Institute of Health Sciences].
Raw alprostajil material was examined for preparation of the "Alprostajil Reference Standard (Control 921)". Analytical data obtained were as follows: infrared spectrum, the same as that of the USP Alprostajil Reference Standard; thin-layer chromatography, no impurities were detected up to 20 micro g; high-performance liquid chromatography (HPLC), no impurities were detected; assay result, 99.6% by HPLC. Based on the above findings, this raw material was authorized as the NIHS Alprostajil Reference Standard (Control 921).
Kitajima
A
A
Yoshii
K
K
Komatsu
H
H
Ishimitsu
S
S
Okada
S
S
D000527:Alprostadil / Q000032:analysis / Q000592:standards*; D002851:Chromatography, High Pressure Liquid; D002855:Chromatography, Thin Layer; D007564:Japan; D013055:Spectrophotometry, Infrared
D000527:Alprostadil