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For the SPPS/LPPS manufacturing process used for tirzepatide, UHPLC-MS methods were developed specifically for quantitation of peptide fragment-related impurities that co-elute with the main peak in UV chromatograms validated per ICH Q2(R1) across the range of 0.1% to 1.0% w/w per the USP Workshop on Therapeutic Peptides (2022)