FDA Sets Peptide Impurity Thresholds as Low as 0.10%, Oath Research Analysis Finds

The U.S. FDA guidance for synthetic peptide drugs requires identifying impurities above 0.10% and limiting new impurities to a maximum of 0.5%. Oath Research (a peptide supplier) released an analysis of how the guidance affects development/quality requirements, but no company-specific financial impact was stated.

Analysis

The U.S. FDA guidance for synthetic peptide drugs requires identifying impurities above 0.10% and limiting new impurities to a maximum of 0.5%. Oath Research (a peptide supplier) released an analysis of how the guidance affects development/quality requirements, but no company-specific financial impact was stated.