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DeFronzo RA, Triplitt C, Qu Y, Lewis MS, Maggs D, Glass LC

Ultra-high-performance liquid chromatography (UHPLC) coupled with high-resolution mass spectrometry, two-dimensional liquid chromatography for resolving co-eluting impurities, and capillary electrophoresis for sequence verification are among the techniques that GLP-1 manufacturers have had to develop and validate at GMP scale to meet the analytical control requirements of regulatory submissions

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