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

页码：293 / 299

页数：7

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