Development and validation of chromatographic methods for the identification and quantitation of organic compounds leached from a laminated polyolefin material.
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.
Jenke
Dennis
D
Technology Resources Division, Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, USA. dennis_jenke@baxter.com
Poss
Mitchell
M
Story
James
J
Odufu
Alex
A
Zietlow
David
D
Tsilipetros
Tom
T