Τίτλος:
Migration study of 1,3-butadiene in eye-drop solutions
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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. © 2012 Informa Healthcare USA, Inc.
Συγγραφείς:
Pistos, C.
Karampela, S.
Vardakou, I.
Papoutsis, I.
Spiliopoulou, C.
Athanaselis, S.
Περιοδικό:
Drug and Chemical Toxicology
Λέξεις-κλειδιά:
1,3 butadiene; eye drops, article; calibration; gas chromatography; headspace gas chromatography flame ionization; temperature dependence; toxicity; validation process, Butadienes; Chemistry Techniques, Analytical; Drug Contamination; Drug Packaging; Flame Ionization; Ophthalmic Solutions; Sensitivity and Specificity; Temperature; Time Factors; Toxicity Tests
DOI:
10.3109/01480545.2011.607826
