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Peptide Impurity

Meaning

Peptide impurity refers to any substance present within a synthesized or manufactured peptide product that is chemically distinct from the intended, primary therapeutic peptide molecule. These undesirable substances can encompass a range of chemical entities, including truncated peptide sequences, various oxidized forms, specific enantiomers, or residual organic chemicals originating from the synthesis or purification process. The concentration and precise identification of these impurities are critical quality control metrics, as their presence can potentially reduce the therapeutic peptide’s intended efficacy, fundamentally alter its pharmacological action, or introduce unpredictable immunological or toxicological risks in a clinical setting.