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FDA guidance issued in 2021 for abbreviated applications covering certain highly purified synthetic peptides requires that every impurity present above 0.10 percent of the active ingredient be individually identified and characterized, and treats any new peptide-related impurity above 0.5 percent as a categorical barrier, with anything between those thresholds requiring detailed scientific justification

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[DOI] [PMC free article] [PubMed] [Google Scholar] 799.Domínguez JF, Ng AC, Poudel G, Stout JC, Churchyard A, Chua P, et al