Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8551414 | Regulatory Toxicology and Pharmacology | 2018 | 10 Pages |
Abstract
A non-target analysis was developed for the analysis of extractables from multi-layer coextrusion bags exposed to 4% benzyl alcohol solution and 0.1â¯M sodium acetate at pHâ¯=â¯5 for defined periods (15 day, 45 day and 90 day) according to manufacturer instructions based on the ultra-performance liquid chromatography (UPLC) quadrupole-time of flight mass spectrometry (Q-TOF MS). In order to confirm the extractables, principal component analysis (PCA) was used to indicate the differences among samples of different periods. Then, the extractables were identified based on searching the self-built library or online searching. The total content of extractables of 90 day samples was 589.78â¯Î¼g/L, and the content was in the range of acceptable levels for pharmaceutical manufacturers. The risk assessment of the extractables were evaluated by Toxtree and T.E.S.T. software to avoid the animals bioexperiment.
Keywords
Related Topics
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Environmental Science
Health, Toxicology and Mutagenesis
Authors
Jingcong Zhuang, Xuebin Xing, Di Wang, Zhenxia Du, Jianfeng Wang, Yan Dong, Wenlian Yu, Sajid Hussain Siyal,