Control of the Diastereoisomeric Impurities in Synthetic Peptide Drugs

OBJECTIVE To discuss the research and control of diastereoisomeric impurities in synthetic peptide drugs development. METHODS The racemic mechanisms during a peptide-bond-forming reation were introduced, recommendations were provided on quality control of synthetic materials, control of manufacturing process, and choice of analytical methods. RESULTS Diastereoisomers are important part of related substances in synthetic peptide drugs development. CONCLUSION More attention should be paid to the research and control of diastereoisomeric impurities.