Stability of refrigerated and frozen solutions of tropisetron in either polyvinylchloride or polyolefin infusion bags

J Clin Pharm Ther. 1997 Aug;22(4):257-60. doi: 10.1046/j.1365-2710.1997.9675096.x.


Objective: To investigate the stability of 50 microg/ml tropisetron in 0.9% sodium chloride or 5% dextrose injections on storage in either 100 ml polyvinylchloride (Tuliflex) or polyolefin (Clear-flex) infusion bags, at +4 degrees C and -20 degrees C.

Method: A stability-indicating high-performance liquid chromatography (HPLC) assay was used to measure residual drug at day 0 (D0), D8, D15, D30, D60 and D90 for each bag. Samples were tested for pH at D0, D60 and D90. Frozen samples were thawed in a microwave oven according to a validated procedure before analysis.

Results: In 0.9% sodium chloride and 5% dextrose, no degradation products were observed in any of the chromatograms. No admixtures, at any time, contained less than 98.2% of the initial concentration. Only minor changes (-0.12 unit) in pH occurred over the storage period. No colour or other visual changes were seen in any sample.

Conclusion: Tropisetron (50 microg/ml) in either 0.9% sodium chloride or 5% dextrose is chemically stable in polyvinylchloride or polyolefin bags for at least 3 months when stored in a refrigerator or in a frozen state.

MeSH terms

  • Drug Stability
  • Drug Storage
  • Freezing
  • Glucose / chemistry
  • Indoles / analysis
  • Indoles / chemistry*
  • Polyenes*
  • Polyvinyl Chloride*
  • Refrigeration
  • Serotonin Antagonists / analysis
  • Serotonin Antagonists / chemistry*
  • Sodium Chloride / chemistry
  • Solutions / chemistry*
  • Tropisetron


  • Indoles
  • Polyenes
  • Serotonin Antagonists
  • Solutions
  • Sodium Chloride
  • Tropisetron
  • PL 732
  • Polyvinyl Chloride
  • Glucose