Abstract
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.
- Received February 16, 1995.
- Accepted July 13, 1995.
- Copyright © Parenteral Drug Association. All rights reserved.
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