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Extractables in Packaging used in the Pharmaceutical Industry


Use of Thermal Desorption GC-MS to Characterize Packaging Materials for Potential Extractables

Keywords: Thermal desorption, Gas chromatography, Mass spectrometry, Extractables, Labels, PVC, Lyophile stoppers

ABSTRACT

Use of Thermal Desorption GC-MS to Characterize Packaging Materials for Potential Extractables

CINDY ZWEIBEN* and ARTHUR J. SHAW

Pfizer Global Research & Development, Groton/New London Laboratories, Pfizer, Inc., Groton, CT 06340

PDA J Pharm Sci and Tech 2009, 63 353-359

Available for download at journal.pda.org

This article presents case studies involving the use of thermal desorption gas chromatography-mass spectrometry to compositionally characterize pharmaceutical packaging materials for potential extractables. Knowl­edge of potential extractables and leachables early in the product development program allows the project team to make informed decisions, potentially minimizing redevelopment efforts and reducing cost. Case studies include selection of a label for use on a polyethylene bottle, selection of a drug contact surface of a blister packaging system, and selection of a stopper.

* Corresponding author: Cindy Zweiben, Pfizer, Inc., MS 4086 Eastern Point Road, Groton, CT 06340. Email: Cindy.Zweiben@Pfizer.com