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J Pharm Biomed Anal. 2004 Apr 1;35(1):57-64.

Analysis by liquid chromatography and infrared spectrometry of di(2-ethylhexyl)phthalate released by multilayer infusion tubing.

Author information

1
Service Pharmacie, Hôpital Gabriel Montpied, Rue Montalembert, Place Henri Dunant BP69, 63003 Clermont-Ferrand Cedex, France.

Abstract

Di(2-ethylhexyl)phthalate (DEHP), a plasticiser present in infusion equipment, is known to be harmful to human health. Various studies have shown that DEHP is released into drug solutions from polyvinyl chloride (PVC) infusion lines. New multi-layer tubing has therefore been marketed to overcome this problem. We assessed the inertness of this tubing when placed in contact with a solution of CELLTOP. Chromatographic assay of DEHP showed no significant difference in DEHP levels in the solution when placed in contact with PVC and with multi-layer tubing. Analysis by infrared spectrometry showed that DEHP was initially present in the polyethylene layer of the multi-layer tubing even before contact with the drug solution. Contact with the solution results in release of DEHP from the container into the contents. The substance responsible for this release is in fact an excipient of CELLTOP, polysorbate. This release of DEHP further proves to depend on parameters such as temperature, time of contact between solution and tubing, and the concentration of polysorbate in the infused drug solution.

PMID:
15030880
DOI:
10.1016/j.jpba.2003.12.018
[Indexed for MEDLINE]

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