Laboratory of Forensic Medicine and Toxicology, Medical School, National and Kapodistrian University of Athens, Athens, Greece.
Drug Chem Toxicol. 2012 Jul;35(3):293-9. doi: 10.3109/01480545.2011.607826. Epub 2011 Dec 21.
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.
药品中浸出物/可提取物的潜在有害影响促使 USP、EP 和 JP 要求对容器/密封系统进行浸出物和毒性测试。为此，开发并验证了一种顶空气相色谱-火焰离子化检测法，用于测定眼用溶液中药物容器/密封系统中潜在可提取物 1,3-丁二烯（1,3-BD）的含量。进一步将迁移研究应用于 8 种眼用溶液（目前市售产品），在不同温度下对这些产品进行短期和长期暴露后。该方法能够建立 1,3-BD 的安全性鉴定阈值，从而能够监测该残留物的眼用溶液产品。
