Shelf-life determination of prostaglandin E1 injections.
A rapid stability indicating assay for the determination of prostaglandin E1 (PGE1) in pharmaceuticals was developed using High Pressure Liquid Chromatography (HPLC). A solution of 20 micrograms/ml PGE1 in 4% alcohol and 0.9% saline has an activation energy of 18,683 cal/mol and the predicted shelf-lives were: at 4 degrees C t95 = 51.8 days and t90 = 106.5 days and at 25 degrees C t95 = 4.8 days and t90 = 9.8 days.
Shulman
N H
NH
Area Quality Control Laboratory, Western Infirmary, Glasgow.
Fyfe
R K
RK
D000527:Alprostadil / Q000737:chemistry / Q000378:metabolism*; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage / Q000592:standards*; D000431:Ethanol / Q000737:chemistry; D012462:Saline Solution, Hypertonic / Q000737:chemistry; D013696:Temperature
D012462:Saline Solution, Hypertonic; D000431:Ethanol; D000527:Alprostadil