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The European Medicines Agencys 2025 synthetic peptide quality guideline treats peptide-related impurities as first-class critical quality attributes: deletion and truncated sequences, dimers, oligomers, and degradation products each need characterization, with European Pharmacopoeia practice pointing to reporting thresholds at 0.1% and identification thresholds above 0.5% for peptide-related impurities in pharmaceutical use

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Some countries also require pre-approval from their health ministry

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This slow approach allows the body to adapt to each receptors activation, reducing gastrointestinal side effects that commonly occur with incretin medications

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Batch-specific data are provided on the Certificate of Analysis (CoA)

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Theoharides TC, Alysandratos KD, Angelidou A, Delivanis DA, Sismanopoulos N, Zhang B, et al

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