TY - JOUR T1 - Stability of Revex<sup>™</sup>, Nalmefene Hydrochloride Injection JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 35 LP - 39 VL - 50 IS - 1 AU - Harry G. Brittain AU - Linda Lafferty AU - Petranna Bousserski AU - Glenn Diegnan AU - Ralph Lessor AU - Camille Small AU - Satish Pejaver Y1 - 1996/01/01 UR - http://journal.pda.org/content/50/1/35.abstract N2 - 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. ER -