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Regulatory submissions involving 2D NMR peptide characterization commonly include: Complete proton resonance assignment tables COSY-derived coupling constant analyses NOESY-derived distance restraint lists Ensembles of calculated structures with RMSD and Ramachandran statistics Spectral comparability studies between drug substance and reference standards 2D NMR characterization is especially valuable in IND submissions involving first-in-class peptide therapeutics where crystallographic analysis is impractical and where biologically relevant solution-state conformations are more informative than crystal packing arrangements

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