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[DOI] [PubMed] [Google Scholar] 118.Klibanov, O

Product-Quality Risks Incorrect amino-acid sequence Free peptide supplied as an undeclared salt Incorrect acetate content Incorrect net peptide quantity Deletion or insertion sequences Oxidation of the tryptophan residue Hydrolytic degradation Peptide aggregates or complexes Residual synthesis reagents Residual solvents Unverified bacterial-endotoxin control Unverified microbiological quality Certificates unrelated to the supplied batch Damage during uncontrolled storage or transport Limited adverse-event reports do not establish safety A product without widespread regulated clinical use will not generate a mature pharmacovigilance database