Toxicity potential of compounds found in parenteral solutions with rubber stoppers.
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.
Danielson
J W
JW
Sterility Analysis Research Center, Food and Drug Administration, Minneapolis, Minnesota.
D004340:Drug Contamination; D004349:Drug Packaging; D007267:Injections; D012408:Rubber; D012996:Solutions / Q000032:analysis*
D012996:Solutions; D012408:Rubber