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.
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