Capillary GC analysis of compounds leached into parenteral solutions packaged in plastic bags.
A number of investigators have reported finding the plasticizer di(2-ethylhexyl)phthalate in plasma, urine, and parenteral solutions. These findings have been associated with the use of polyvinyl chloride packaging materials. Capillary gas chromatography--mass spectrometry, packed column gas chromatography, and high-performance liquid chromatography were used for the analyses. The screening procedure described herein accurately and quantitatively analyzes the plasticizers di(2-ethylhexyl)phthalate and dibutylphthalate and some of the degradation products plus 2,6-di-tert-butyl-p-cresol and cyclohexanone. Liquid--liquid extraction followed by capillary gas chromatography is used. Linear regression analysis of standard solutions gives correlation coefficients from 0.99963 to 0.99989 for six compounds. Recoveries for these compounds vary from 84.9% to 114% with relative standard deviations ranging from 2.51% to 6.33%.
Snell
R P
RP
Food and Drug Administration, Sterility Analysis Research Center, Minneapolis, Minnesota 55455.
D002849:Chromatography, Gas; D004051:Diethylhexyl Phthalate / Q000032:analysis; D004340:Drug Contamination; D004349:Drug Packaging; D007202:Indicators and Reagents; D007263:Infusions, Parenteral / Q000295:instrumentation*; D010969:Plastics
D007202:Indicators and Reagents; D010969:Plastics; D004051:Diethylhexyl Phthalate