title: Profiling of metal ions leached from pharmaceutical packaging materials.
abstract: Metal leachables from packaging components can affect the safety and efficacy of a pharmaceutical formulation. As liquid formulations continue to contain surfactants, salts, and chelating agents coupled with lower drug levels, the interaction between the formulation and the packaging material becomes more important. This study examines the interaction of commonly used packaging materials with extraction solvents representative of liquid formulations found in the pharmaceutical industry stressed under conditions encountered during accelerated stability studies.
authors.affiliation: Merck Manufacturing Division, West Point, PA 19486, USA. kyle_fliszar@merck.com
authors.forename: Kyle A
authors.initials: KA
authors.lastname: Fliszar
authors.forename: David
authors.initials: D
authors.lastname: Walker
authors.forename: Leonardo
authors.initials: L
authors.lastname: Allain
mesh_terms: D002626:Chemistry, Pharmaceutical; D004349:Drug Packaging; D005079:Excipients; D005898:Glass; D007477:Ions; D008670:Metals / Q000737:chemistry*; D019999:Pharmaceutical Solutions; D010969:Plastics; D012015:Reference Standards; D012997:Solvents; D013054:Spectrophotometry, Atomic
chemical_list: D005079:Excipients; D007477:Ions; D008670:Metals; D019999:Pharmaceutical Solutions; D010969:Plastics; D012997:Solvents