Journal
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Volume 152, Issue -, Pages 197-203Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jpba.2018.01.053
Keywords
Pharmaceutical packaging; Pharmaceutical analysis; Polymer additive; Active pharmaceutical ingredient; Mass spectroscopy; Extractables and leachables
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Funding
- Akorn Pharmaceuticals Inc.
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Pharmaceutical packaging employs a wide variety of polymers owing to their desirable features, but the compounds that could leach from the polymers into the drug products can pose serious health risks. Therefore, it is extremely important to identify such compounds so that they can be adequately quantified and evaluated for toxicological impact/safety assessments. Not only the polymer components and the additives should be considered as sources for leachable impurities, their reaction/degradation products should also be evaluated. Irganox 1010 is a common commercial antioxidant (polymer additive) used in the manufacturing of polyolefin materials for container closure systems. In our study, we identified two Irganox1010 related leachable impurities in an ophthalmic drug product using rapid and straightforward orthogonal mass spectroscopy (LC-MS and GC-MS) methods The identified impurities were 7,9-Di-tert-butyl-1 oxaspiro[4.5]cleca-6,9-diene-2,8-dione and 3-(3,5-bis(tert-butyl)-1-hydroxy-4-oxocyclohexa-2,5-dienyl Ipropanoic acid which leached into the ophthalmic drug solution during storage. The analytical methods employed could potentially be used to identify the similar class of compounds as is or in drug products. (C) 2018 Elsevier B.V. All rights reserved.
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