Development and Validation of Chromatographic Methods for the Identification and Quantitation of Organic Compounds Leached from a Laminated Polyolefin Material
Open Access
- 1 August 2004
- journal article
- research article
- Published by Oxford University Press (OUP) in Journal of Chromatographic Science
- Vol. 42 (7) , 388-395
- https://doi.org/10.1093/chromsci/42.7.388
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.Keywords
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