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Peptide-Related Impurities

Meaning

Unwanted chemical substances present within a synthesized peptide drug product that are structurally similar to the active pharmaceutical ingredient but lack the intended biological activity or may introduce adverse effects. These impurities arise primarily during the complex chemical synthesis process of peptides, often as truncated sequences, oxidized forms, or aggregation products. Their presence must be rigorously controlled and quantified to ensure the drug’s purity, efficacy, and patient safety in clinical application.