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


METHODS
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.


CONCLUSIONS
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.
Georget
S
S
Centre Hospitalier Universitaire, Pharmacie Brabois Adultes, Vandoeuvre-les-Nancy, France.
Vigneron
J
J
Blaise
N
N
Perrin
A
A
Hoffman
M A
MA
Hoffman
M
M
D004355:Drug Stability; D004356:Drug Storage; D005615:Freezing; D005947:Glucose / Q000737:chemistry; D007211:Indoles / Q000032:analysis / Q000737:chemistry*; D011090:Polyenes; D011143:Polyvinyl Chloride; D012034:Refrigeration; D012702:Serotonin Antagonists / Q000032:analysis / Q000737:chemistry*; D012965:Sodium Chloride / Q000737:chemistry; D012996:Solutions / Q000737:chemistry*; D000077526:Tropisetron
D007211:Indoles; D011090:Polyenes; D012702:Serotonin Antagonists; D012996:Solutions; D012965:Sodium Chloride; D000077526:Tropisetron; C035051:PL 732; D011143:Polyvinyl Chloride; D005947:Glucose