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Friday, March 27 • 09:00 - 17:00
Evaluation of DEHP Leachable in a Heparin IV Product

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A pre-filled heparin sodium intravenous (IV) product is packed in disposable plastic bags made from polyvinyl chloride (PVC) using up to 30-35% Di-2-ethylhexyl phthalate (DEHP) as plasticizer. An HPLC-MS method and LLE extraction method have been developed for determination of trace amounts of DEHP in IV solutions. Evaluation of DEHP leachable in the heparin IV product at normal storage conditions and at elevated temperature for different periods of time is ongoing to confirm that DEHP release in the heparin product does not exceed the stated 5 ppm limit, as DEHP is a chemical with severe adverse health effects.

Friday March 27, 2020 09:00 - 17:00 EDT