Ss. Murthy et Hg. Brittain, STABILITY OF REVEX, NALMEFENE HYDROCHLORIDE INJECTION, IN INJECTABLE SOLUTIONS, Journal of pharmaceutical and biomedical analysis, 15(2), 1996, pp. 221-226
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.