peptide impurities synthesis


Peptide drugs are composed of different kinds of amino acids in a certain order. According to the process characteristics of polypeptide drugs, there are many synthetic steps, and the resulting impurities are complex. The related substances of synthetic peptides mainly include: process impurities such as missing peptides, broken peptides, oxidized peptides and other peptide related substances introduced in the synthesis process; Degradation products and polymers produced by peptide deamidation, oxidation, hydrolysis, disulfide bond mismatch, racemization and other unstable factors. Peptide preparations are mainly powder injection, which are prone to degradation changes and degradation impurities during production and storage. Due to the large number of impurities, complex components and different properties in synthetic peptides, some of them are very similar to peptide API and some are quite different, such impurities may have great toxicity at low concentrations. 

According to relevant research reports, even if only oneortwo amino acids in the peptide change in order, it may change the agonist into an antagonist and have the opposite effect, Because the safety of drugs is not only the toxicity of the main active ingredients but also the toxicity of impurities, the establishment of appropriate methods to detect these impurities for the analysis of related substances is the key to the quality control of polypeptide drugs. In the appendix "substances for pharmaceutical use" of European Pharmacopoeia 7.0, the limits of related substances of peptide drugs have been defined, and the reporting limit (0.1%), identification limit (0.5%) and quality control limit (1.0%) are respectively established. Therefore, we should pay attention to the research and control of impurities related to peptide drugs.

Omizzur biotech customized synthesized the following peptide impurities and provided the HPLC, MS and COA analysis reports of this batch. Any inquiry please contact our customer services to obtain the latest product quotation and delivery time.