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Toxicity potential of compounds found in parenteral solutions with rubber stoppers
1Sterility Analysis Research Center, Food and Drug Administration, Minneapolis, Minnesota.
Journal of Parenteral Science and Technology : a Publication of the Parenteral Drug Association
|March 1, 1992
Abstract:
Leached stopper components found in parenteral solutions produced by several manufacturers were identified and quantitated. Their toxicity potential was determined by comparing the types and quantities of the leached components with known toxicity levels and/or harmful effects. Toxicity potentials for benzaldehyde, 2-butoxyethanol, cyclohexanone, ethylbenzene, 1,1,2,2-tetrachloroethane, and tetrachloroethylene are listed. Breakdown products of dextrose (furfural and 5-hydroxymethylfurfural), which may also have harmful effects, were quantitated.