@article{2981602,
    title = "Migration study of 1,3-butadiene in eye-drop solutions",
    author = "Pistos, C. and Karampela, S. and Vardakou, I. and Papoutsis, I. and Spiliopoulou, C. and Athanaselis, S.",
    journal = "Drug and Chemical Toxicology",
    year = "2012",
    volume = "35",
    number = "3",
    pages = "293-299",
    issn = "0148-0545, 1525-6014",
    doi = "10.3109/01480545.2011.607826",
    keywords = "1,3 butadiene;  eye drops, article;  calibration;  gas chromatography;  headspace gas chromatography flame ionization;  temperature dependence;  toxicity;  validation process, Butadienes;  Chemistry Techniques, Analytical;  Drug Contamination;  Drug Packaging;  Flame Ionization;  Ophthalmic Solutions;  Sensitivity and Specificity;  Temperature;  Time Factors;  Toxicity Tests",
    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. © 2012 Informa Healthcare USA, Inc."
}