Effect of sterilization process on the formation of mono(2-ethylhexyl)phthalate from di(2-ethylhexyl)phthalate.
The risk assessment of di(2-ethylhexyl)phthalate (DEHP) migrating from polyvinyl chloride (PVC) medical devices is an important issue. Many studies have been conducted to determine the level of DEHP migration. A recent report has indicated that DEHP in blood bags is hydrolyzed by esterase into mono(2-ethylhexyl)phthalate (MEHP). However, MEHP is thought to be even more toxic than the parent compound. Therefore, a method for the simultaneous determination of DEHP and MEHP was developed. The limits of quantification (LOQs) of DEHP and MEHP were 2.5 and 0.75 ng/ml, respectively. In this study, the effect of sterilization process on the levels of DEHP and MEHP migration was investigated. The level of migration of DEHP from gamma(gamma)-ray sterilized PVC sheet was low compared with that of the unsterilized control. By contrast, the level of MEHP migration from the gamma-ray sterilized PVC sheet was high compared with that of the unsterilized control. In addition, a high content of MEHP was found in the gamma-ray sterilized PVC sheet.
Department of Analytical Chemistry, Faculty of Pharmaceutical Sciences, Hoshi University, 2-4-41 Ebara, Shinagawa-ku, Tokyo 142-8501, Japan.
Rie
R
Ito
Fumie
F
Seshimo
Naoko
N
Miura
Migaku
M
Kawaguchi
Koichi
K
Saito
Hiroyuki
H
Nakazawa
D002853:Chromatography, Liquid / Q000379:methods; D004051:Diethylhexyl Phthalate / Q000031:analogs & derivatives* / Q000032:analysis* / Q000138:chemical synthesis / Q000737:chemistry / Q000633:toxicity; D004864:Equipment and Supplies; D005720:Gamma Rays; D011143:Polyvinyl Chloride / Q000737:chemistry* / Q000528:radiation effects; D015203:Reproducibility of Results; D018570:Risk Assessment; D021241:Spectrometry, Mass, Electrospray Ionization; D013242:Sterilization
D011143:Polyvinyl Chloride; D004051:Diethylhexyl Phthalate; C016599:mono-(2-ethylhexyl)phthalate