RT Journal Article
SR Electronic
T1 Use of Thermal Desorption GC-MS to Characterize Packaging Materials for Potential Extractables
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 353
OP 359
VO 63
IS 4
A1 Cindy Zweiben
A1 Arthur J. Shaw
YR 2009
UL http://journal.pda.org/content/63/4/353.abstract
AB 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.