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. 2017 Jul 21;9:87–99. doi: 10.2147/CPAA.S131832

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© 2017 Shannon et al. This work is published and licensed by Dove Medical Press Limited

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Stability data for the quantitative stability-indicating assays (A) HIC, (B) SE-HPLC, and (C) SDS-PAGE Coomassie for etanercept 25 mg (n=6 batches) and 50 mg PFS DP (n=7 batches) at the alternative storage condition of 4 weeks at 30°C, following storage at the recommended condition of 5°C±3°C for 30 or 36 months.

Abbreviations: HIC, hydrophobic interaction chromatography; PFS, prefilled syringe; SE-HPLC, size exclusion high-performance liquid chromatography; SDS-PAGE, sodium dodecyl sulfate-polyacrylamide gel electrophoresis; LMW, low molecular weight; HMW, high molecular weight; DP, drug product.