RT Journal Article SR Electronic T1 Stability of Revex™, Nalmefene Hydrochloride Injection JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 35 OP 39 VO 50 IS 1 A1 Brittain, Harry G. A1 Lafferty, Linda A1 Bousserski, Petranna A1 Diegnan, Glenn A1 Lessor, Ralph A1 Small, Camille A1 Pejaver, Satish YR 1996 UL http://journal.pda.org/content/50/1/35.abstract AB 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 0.000441 month–1 was deduced for the reactions taking place at 25°C. This low value is consistent with the excellent stability exhibited by the product, and amply justifies its shelf life.