Effect of sterilization process on the formation of mono(2-ethylhexyl)phthalate from di(2-ethylhexyl)phthalate
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Ito, Rie
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Seshimo, Fumie
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Hoshi Univ, Fac Pharmaceut Sci, Dept Analyt Chem, Shinagawa Ku, Tokyo 1428501, JapanHoshi Univ, Fac Pharmaceut Sci, Dept Analyt Chem, Shinagawa Ku, Tokyo 1428501, Japan
Seshimo, Fumie
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Miura, Naoko
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Hoshi Univ, Fac Pharmaceut Sci, Dept Analyt Chem, Shinagawa Ku, Tokyo 1428501, JapanHoshi Univ, Fac Pharmaceut Sci, Dept Analyt Chem, Shinagawa Ku, Tokyo 1428501, Japan
Miura, Naoko
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Kawaguchi, Migaku
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Hoshi Univ, Fac Pharmaceut Sci, Dept Analyt Chem, Shinagawa Ku, Tokyo 1428501, JapanHoshi Univ, Fac Pharmaceut Sci, Dept Analyt Chem, Shinagawa Ku, Tokyo 1428501, Japan
Kawaguchi, Migaku
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Saito, Koichi
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Hoshi Univ, Fac Pharmaceut Sci, Dept Analyt Chem, Shinagawa Ku, Tokyo 1428501, JapanHoshi Univ, Fac Pharmaceut Sci, Dept Analyt Chem, Shinagawa Ku, Tokyo 1428501, Japan
Saito, Koichi
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Nakazawa, Hiroyuki
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Hoshi Univ, Fac Pharmaceut Sci, Dept Analyt Chem, Shinagawa Ku, Tokyo 1428501, JapanHoshi Univ, Fac Pharmaceut Sci, Dept Analyt Chem, Shinagawa Ku, Tokyo 1428501, Japan
Nakazawa, Hiroyuki
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[1] Hoshi Univ, Fac Pharmaceut Sci, Dept Analyt Chem, Shinagawa Ku, Tokyo 1428501, Japan
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. (c) 2006 Elsevier B.V. All rights reserved.