Tiered analytics for purity assessment of macrocyclic peptides in drug discovery: Analytical consideration and method development.

Jingfang Jenny Qian Cutrone,Xiaohua Stella Huang,Edward S Kozlowski,Ye Bao,Yingzi Wang, Christopher S Poronsky,Dieter M Drexler,Adrienne A Tymiak

Journal of Pharmaceutical and Biomedical Analysis（2017）

Cited 4|Views22

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Abstract

•Column screening and temperature-dependent HPLC study.•API content estimation by incorporating q-NMR and HPLC analysis.•Tiered analytics to purity assessment at different drug discovery stages.•Analytical characterization of macrocyclic peptide development candidates.•Batch to batch consistency of scale-up lots for macrocyclic peptide development candidates.

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Key words

Purity assessment,Chromatography,Tiered analytics,Macrocyclic peptide,Drug discovery

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