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Impurity Control Strategies For Therapeutic Peptides

Peptides are an important class of molecules placed between small molecules and biomolecules. Synthetic peptide-related impurities can originate. ....

Mark Strege , Baole Zhang , Julie Zhang , Nikhil Rautela , Mark Kerr , Triptorelin Pamoate , Eli Lilly , Global Biologics Department , United States Pharmacopeial Convention , Pharmacopeial Forum , Expert Committee , Therapeutic Peptides , Quality Risk Management , Mutagenic Impurities , European Pharmacopeiachapter , Listed Drugs , Hybio Pharmaceutical , Standards And Next , Biologics Monographs , Quality Attributes , Synthetic Peptide Drug Substances , Glucagon Bioidentity Tests , Starting Materials , Chemical Synthesis , Gonadorelin Acetate , Ganirelix Acetate ,