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Neuropsychopharmacology 29(11):20882096
Manual validation ensured accurate identification of all amino acid residues and post-translational modifications. Nuclear Magnetic Resonance (NMR) Spectroscopy To complement mass spectrometric data, ^1H and ^13C NMR spectroscopy were performed, providing insights into the conformational aspects and confirming the presence of specific functional groups, particularly in modified regions. Quality Control and Batch-to-Batch Comparability Assessment (New Section) Beyond single-batch characterization, peptide sequencing plays a vital role in establishing batch-to-batch consistency during late-stage development
19 Nevertheless, in 2017, the FDA added an warning to Januvia's package insert that advised prescribers to weigh the risks and benefits of sitagliptin in patients at risk for HF before initiating therapy
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