Migration study of 1,3-butadiene in eye-drop solutions

被引：4
|
作者：
Pistos, Constantinos [1 ]
Karampela, Sevasti [1 ]
Vardakou, Ioanna [1 ]
Papoutsis, Ioannis [1 ]
Spiliopoulou, Chara [1 ]
Athanaselis, Sotiris [1 ]
机构：
[1] Univ Athens, Sch Med, Lab Forens Med & Toxicol, Athens 11527, Greece
来源：
DRUG AND CHEMICAL TOXICOLOGY | 2012年 / 35卷 / 03期
关键词：
Extractables; residues; solvent; formulation; GAS-CHROMATOGRAPHIC DETERMINATION; TOBACCO-SMOKE; BUTADIENE; INHALATION; PRODUCTS; EXPOSURE; PLASTICS; BENZENE; STYRENE; BLOOD;
D O I：
10.3109/01480545.2011.607826
中图分类号：
O6 [化学];
学科分类号：
0703 ;
摘要：
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.
引用
收藏
页码：293 / 299
页数：7
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