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1334063 
Technical Report 
Evaluation of diethylhexyl phthalate leaching from polyvinyl chloride containers by selected drugs and formulation components 
Pearson, SD; Trissel, LA 
1992 
0 
ASHP Midyear Clinical Meeting Symposium Highlights
ISSN: 1557-0606 
IPA/93/1016635 
VOL 27 ISS Dec 1992 
REF 
English 
IPA COPYRIGHT: ASHP The purpose of this project was to evaluate the extent of leaching of DEHP plasticizer from PVC bags by 12 drugs and several organic solvents and surfactants used as formulation components. Twelve drugs formulated with the organic solvents ethanol, polyethylene glycol, and propylene glycol along with drugs containing the surfactants polysorbate 80 and polyoxyethylated castor oil (Cremophor R EL) admixed in PVC bags of 5% dextrose injection were evaluated initially and after four, eight, and 24 hours at room temperature. The quantities of DEHP present in the test solutions were determined using an HPLC analytical procedure utilizing a C8 reverse phase column. The mobile phase consisted of methanol and 1% acetic acid (87:13) run isocratically. The flow rate was 1 ml/min and detection was performed at 254 nm. All samples were prepared in duplicate and duplicate determinations were performed on each sample. Ethanol, polyethylene glycol, and propylene glycol at a concentration of 25% did not result in any detectable leached DEHP within the study period. However, the surfactant polysorbate 80 in concentrations of 1 to 25% leached detectable DEHP in one to four hours. In 24 hours, DEHP levels ranged from approximately 36 mcg/ml in the 1% concentration up to 237 mcg/ml in the 25% concentration. Similar results were observed with equal parts of polysorbate 80 plus ethanol and polyoxyethylated castor oil plus ethanol. Drug products containing surfactants such as cyclosporine, miconazole, teniposide, and the vehicle of taxol and taxotere leached relatively large amounts of DEHP in 24 hours. These drugs that leached DEHP should be prepared in non-PVC containers such as glass bottles or polyolefin bags and administered through polyolefin tubing. 
Diethylhexyl phthalate; plasticizers; leechings; Polyvinyl chloride; containers; IV injections; Practice Interest Areas; Intravenous Therapynfusion Devices; meeting presentations; ASHP meeting abstracts; diethylhexyl phthalate leeching; Stability; drugs; incompatibilities; Incompatibilities; stability; Injections; Additives; plasticizer leeching; Storage