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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Pistos, Constantinos Karampela, Sevasti Vardakou, Ioanna Papoutsis, Ioannis Spiliopoulou, Chara Athanaselis, Sotiris |
| Description | Country affiliation: Greece Author Affiliation: Pistos C ( Laboratory of Forensic Medicine and Toxicology, Medical School, National and Kapodistrian University of Athens, Athens, Greece. cpistos@med.uoa.gr) |
| 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. |
| File Format | HTM / HTML |
| ISSN | 01480545 |
| Issue Number | 3 |
| Volume Number | 35 |
| e-ISSN | 15256014 |
| Journal | Drug and Chemical Toxicology |
| Language | English |
| Publisher | Taylor & Francis |
| Publisher Date | 2012-07-01 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Discipline Toxicology Butadienes Chemistry Chemistry Techniques, Analytical Drug Contamination Prevention & Control Drug Packaging Ophthalmic Solutions Analysis Flame Ionization Methods Sensitivity And Specificity Temperature Time Factors Toxicity Tests Journal Article Validation Studies |
| Content Type | Text |
| Resource Type | Article |
| Subject | Health, Toxicology and Mutagenesis Public Health, Environmental and Occupational Health Toxicology Pharmacology Chemical Health and Safety |
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