TY - JOUR
TI - Migration study of 1,3-butadiene in eye-drop solutions
AU - Pistos, C.
AU - Karampela, S.
AU - Vardakou, I.
AU - Papoutsis, I.
AU - Spiliopoulou, C.
AU - Athanaselis, S.
JO - Drug and Chemical Toxicology
PY - 2012
VL - 35
TODO - 3
SP - 293-299
PB - 
SN - 0148-0545, 1525-6014
TODO - 10.3109/01480545.2011.607826
TODO - 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
TODO - 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.
ER -