STABILITY OF REVEX, NALMEFENE HYDROCHLORIDE INJECTION, IN INJECTABLE SOLUTIONS

The short-term stability of Revex, nalmefene hydrochloride injection, was determined in a number of diluents commonly employed for intraveno us use. An HPLC method was used to follow the potency of the diluted s olutions, and was fully validated for its intended concentration range prior to its use. Dilutions of Revex were prepared separately in 0.9% sodium chloride injection, 0.45% sodium chloride injection, 5% dextro se injection, 5% dextrose and 0.45% sodium chloride injection, lactate d Ringer's injection, 5% dextrose and lactated Ringer's injection and 5% sodium hydrogencarbonate injection. Each admixture was stored at 4 degrees C, room temperature (21 degrees C) and 40 degrees C, with samp les being tested after storage at each temperature for 0, 24, 48 and 7 2 h. Defining stability as the retention of at least 95% of the initia l drug concentration at the end of the storage period, it was conclude d that the diluted solutions of Revex were uniformly stable for up to 72 h in all of the injectable solutions maintained at either 4, 21 or 40 degrees C.