STABILITY OF CISATRACURIUM BESYLATE IN VIALS, SYRINGES, AND INFUSION ADMIXTURES

The stability of cisatracurium besylate was studied. Cisatracurium (as besylate) 2 mg/mL in 5- and 10-mL unopened vials and 10 mg/mL in 20-m L unopened vials, as well as 3 mL of solution from additional 2-mg/mL vials, repackaged in 3-mL sealed plastic syringes, was stored at 4 and 23 degrees C in the dark and in normal fluorescent room light. Admixt ures of cisatracurium las besylate) 0.1, 2, or 5 mg/mL in polyvinyl ch loride (PVC) minibags of 5% dextrose injection or 0.9% sodium chloride injection were stored at 4 and 23 degrees C in nor mal fluorescent ro om light. Triplicate samples for each storage condition were taken ini tially and at 1, 3, 5, 7, 14, 21, and 30 days; samples from vials were also removed at 45 and 90 days. Solutions were stored in sterile vial s at -70 degrees C and then thawed at room temperature before analysis of chemical stability by high-performance liquid chromatography. Phys ical stability was assessed as well. Cisatracurium besylate was physic ally stable in all samples throughout the study. Cisatracurium las bes ylate) 2 mg/mL exhibited drug losses at 23 degrees C in vials at 45 da ys and in syringes at 30 days. Cisatracurium (as besylate) 0.1, 2, and 5 mg/mL in 5% dextrose injection and in 0.9% sodium chloride injectio n was stable for at least 30 days at 4 degrees C, but substantial drug losses occurred at 23 degrees C. Admixtures prepared with cisatracuri um (as besylate) 0.1 mg/mL and with 5% dextrose injection exhibited th e greatest losses. Cisatracurium besylate was stable in most samples f or at least 30 days at 4 and 23 degrees C; admixtures containing cisat racurium (as besylate) 0.1 or 2 mg/mL exhibited substantial drug loss at 23 degrees C.