title: A comprehensive approach for the determination of extractable and leachable metals in pharmaceutical products by inductively-coupled plasma.
abstract: 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.
authors.affiliation: Intertek USA, Inc., d/b/a QTI, Whitehouse, NJ 08888, USA. dan.zuccarello@intertek.com
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Zuccarello
authors.forename: Michael P
authors.initials: MP
authors.lastname: Murphy
authors.forename: Richard F
authors.initials: RF
authors.lastname: Meyer
authors.forename: Paul A
authors.initials: PA
authors.lastname: Winslow
mesh_terms: D003663:Decision Trees; D004340:Drug Contamination / Q000517:prevention & control; D004349:Drug Packaging / Q000592:standards; D004355:Drug Stability; D005506:Food Contamination / Q000517:prevention & control; D013058:Mass Spectrometry / Q000379:methods*; D008670:Metals / Q000032:analysis* / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000592:standards; D013054:Spectrophotometry, Atomic / Q000379:methods*; D013678:Technology, Pharmaceutical / Q000379:methods
chemical_list: D008670:Metals; D004364:Pharmaceutical Preparations