Capillary gas chromatographic determination of cyclohexanone and 2-ethyl-1-hexanol leached from solution administration sets.
A capillary gas chromatographic method is described for the determination of cyclohexanone and 2-ethyl-1-hexanol leached from solution administration sets. A preliminary study was made of compounds leached from solution administration sets by 5% sodium bicarbonate solution (pH 8.1), 0.9% sodium chloride solution (pH 6.8), and water. Water was selected as the leaching solvent because similar quantities of the compounds were leached into water and into both types of parenteral solutions. The correlation coefficients were 0.99977 for cyclohexanone and 0.99974 for 2-ethyl-1-hexanol, and recoveries were good (93-94%). Five administration sets from each of 2 manufacturers were analyzed by this method. The amounts of cyclohexanone that were leached from the individual sets varied considerably; however, similar quantities were leached from sets of both manufacturers. 2-Ethyl-1-hexanol was also found in extracts from each of the sets analyzed.
Danielson
J W
JW
Food and Drug Administration, Sterility Analysis Research Center, Minneapolis, MN 55401.
D002849:Chromatography, Gas; D003512:Cyclohexanones / Q000032:analysis*; D004349:Drug Packaging; D000441:Hexanols / Q000032:analysis*; D007202:Indicators and Reagents; D012996:Solutions
D003512:Cyclohexanones; D000441:Hexanols; D007202:Indicators and Reagents; D012996:Solutions; C036468:cyclohexanone; C034017:2-ethylhexanol