title: Migration study of 1,3-butadiene in eye-drop solutions.
abstract: The potential deleterious effects of extractables/leachables in pharmaceutical products led the USP, EP, and JP to require extractable and toxicity testing of container/closure systems. To that, a headspace gas chromatography flame ionization detection method was developed and validated for the determination of 1,3-butadiene (1,3-BD) as a potential extractable residue from a pharmaceutical container/closure system into eye-drop solutions. A migration study was further applied in eight eye-drop solutions (currently marketed products) after short- and long-term exposure of these products at various temperatures. This method allows the establishment of safety-qualification thresholds for 1,3-BD being capable of monitoring eye-drop solution products for this residue.
authors.affiliation: Laboratory of Forensic Medicine and Toxicology, Medical School, National and Kapodistrian University of Athens, Athens, Greece. cpistos@med.uoa.gr
authors.forename: Constantinos
authors.initials: C
authors.lastname: Pistos
authors.forename: Sevasti
authors.initials: S
authors.lastname: Karampela
authors.forename: Ioanna
authors.initials: I
authors.lastname: Vardakou
authors.forename: Ioannis
authors.initials: I
authors.lastname: Papoutsis
authors.forename: Chara
authors.initials: C
authors.lastname: Spiliopoulou
authors.forename: Sotiris
authors.initials: S
authors.lastname: Athanaselis
mesh_terms: D002070:Butadienes / Q000737:chemistry*; D002623:Chemistry Techniques, Analytical; D004340:Drug Contamination / Q000517:prevention & control*; D004349:Drug Packaging; D005410:Flame Ionization / Q000379:methods; D009883:Ophthalmic Solutions / Q000032:analysis*; D012680:Sensitivity and Specificity; D013696:Temperature; D013997:Time Factors; D018675:Toxicity Tests / Q000379:methods
chemical_list: D002070:Butadienes; D009883:Ophthalmic Solutions; C031763:1,3-butadiene