RT Journal Article
SR Electronic
T1 A Comprehensive Approach for the Determination of Extractable and Leachable Metals in Pharmaceutical Products by Inductively-Coupled Plasma
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 339
OP 352
VO 63
IS 4
A1 Zuccarello, Daniel J.
A1 Murphy, Michael P.
A1 Meyer, Richard F.
A1 Winslow, Paul A.
YR 2009
UL http://journal.pda.org/content/63/4/339.abstract
AB A comprehensive digestive approach for determining the extractable and leachable metals in pharmaceutical products by inductively-coupled plasma is investigated. This study examines several acid digestion strategies for packaging materials, containers, and formulated products for complete trace metals analysis. Packaging materials, a food product, and a simulated drug product are evaluated for leachable metals by stressing the materials under accelerated stability conditions. Trace metal profiles of 64 elements for these materials are reported.