Stability of Revex, nalmefene hydrochloride injection.
The stability of Revex, nalmefene hydrochloride injection, has been studied at several temperatures for periods up to 36 months. The data were obtained using a HPLC method for the potency determination, and for the level of the sole degradation product (2,2'-bisnalmefene). These methods were found to be characterized by excellent precision, linearity, and accuracy over the analyte concentration ranges established. The stability data were found to be interpretable using first-order kinetics, and essentially comparable rate constants were calculated for both the potency loss and the formation of 2,2'-bisnalmefene. Applying the Arrhenius equation to these data, a rate constant of 0.00441 month-1 was deduced for the reactions taking place at 25 degrees C. This low value is consistent with the excellent stability exhibited by the product, and amply justifies its shelf life.
Brittain
H G
HG
Pharmaceutical Products Division, Ohmeda Incorporated, Murray Hill, NJ 07974.
Lafferty
L
L
Bousserski
P
P
Diegnan
G
G
Lessor
R
R
Small
C
C
Pejaver
S
S
D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D009271:Naltrexone / Q000031:analogs & derivatives* / Q000032:analysis; D009292:Narcotic Antagonists / Q000032:analysis*
D009292:Narcotic Antagonists; D009271:Naltrexone; C038981:nalmefene