Stability of cisatracurium besylate in vials, syringes, and infusion admixtures

Am J Health Syst Pharm. 1998 May 15;55(10):1037-41. doi: 10.1093/ajhp/55.10.1037.

Abstract

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-mL 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. Admixtures of cisatracurium (as besylate) 0.1, 2, or 5 mg/mL in polyvinyl chloride (PVC) minibags of 5% dextrose injection or 0.9% sodium chloride injection were stored at 4 and 23 degrees C in normal fluorescent room light. Triplicate samples for each storage condition were taken initially 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 vials at -70 degrees C and then thawed at room temperature before analysis of chemical stability by high-performance liquid chromatography. Physical stability was assessed as well. Cisatracurium besylate was physically stable in all samples throughout the study. Cisatracurium (as besylate) 2 mg/mL exhibited drug losses at 23 degrees C in vials at 45 days 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 injection was stable for at least 30 days at 4 degrees C, but substantial drug losses occurred at 23 degrees C. Admixtures prepared with cisatracurium (as besylate) 0.1 mg/mL and with 5% dextrose injection exhibited the greatest losses. Cisatracurium besylate was stable in most samples for at least 30 days at 4 and 23 degrees C; admixtures containing cisatracurium (as besylate) 0.1 or 2 mg/mL exhibited substantial drug loss at 23 degrees C.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Atracurium / analogs & derivatives*
  • Atracurium / chemistry
  • Drug Stability
  • Glucose / chemistry
  • Neuromuscular Blocking Agents / chemistry*
  • Sodium Chloride / chemistry
  • Solutions

Substances

  • Neuromuscular Blocking Agents
  • Solutions
  • Atracurium
  • Sodium Chloride
  • Glucose
  • cisatracurium