title: Development and validation of chromatographic methods for the identification and quantitation of organic compounds leached from a laminated polyolefin material.
abstract: Chromatographic methods for the identification of organic compounds leached from a plastic material used in solution containers in the pharmaceutical industry are described. Based on a set of compounds identified in extracts of a multilayered polyolefin film, targeted leachables are delineated for accumulation assessments, and methods to perform target quantitation are developed and validated.
authors.affiliation: Technology Resources Division, Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, USA. dennis_jenke@baxter.com
authors.forename: Dennis
authors.initials: D
authors.lastname: Jenke
authors.forename: Mitchell
authors.initials: M
authors.lastname: Poss
authors.forename: James
authors.initials: J
authors.lastname: Story
authors.forename: Alex
authors.initials: A
authors.lastname: Odufu
authors.forename: David
authors.initials: D
authors.lastname: Zietlow
authors.forename: Tom
authors.initials: T
authors.lastname: Tsilipetros