exenatide impurities

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Peptides are reaction products of dehydration condensation of amino acids. According to the definition of the United States Pharmacopoeia, condensation products with less than 40 amino acids are called peptides. Peptides are easy to synthesize and sequence optimized, and their medicinal value can be quickly determined.

Exenatide is a Synthetic Peptide

Exenatide is an active peptide containing 39 amino acids. It is a glucagon-like peptide-1 (GLP-1) analogue. Exenatide has the effect of promoting insulin secretion, enhancing insulin sensitivity and improving insulin cell function, so as to achieve the effect of controlling blood sugar. Exenatide is effective in suppressing appetite, reducing weight, cardiovascular protection, breast cancer and other fields.

Exenatide Impurities & Peptides

In the process of peptide synthesis and storage, related structural impurities are easily formed, such as amino acid loss, amino acid insertion, deamination, degradation products, etc. Many related structural impurities not only have no medicinal effect, but have certain toxic and side effects. Therefore, the European Pharmacopoeia requires qualitative analysis of related structural impurities with a content of more than 0.5%, quantitative analysis of related structural impurities with a content of more than 1% and investigation of their toxic and side effects

Exenatide Synthesis and Impurities

Exenatide is mainly synthesized by the classic solid-phase synthesis method combined with fragment synthesis method. During the synthesis, placement and preparation process of exenatide, some miscellaneous peptides similar in structure and properties to exenatide will be produced, such as Amino acid insertion/deletion, diastereoisomers, etc., the structure and physicochemical properties of these exenatide impurities are almost the same as exenatide. The analysis of these exenatide impurities will help us better understand its medicinal chemical properties and provide more support for the research and development of exenatide.

Peptide Characterization and Exenatide Impurities

The identification of peptides is not simple and can be completed by a single detection. The confirmation of its primary structure generally uses mass spectrometry to determine the relative molecular mass, chromatography to determine the amino acid composition, and mass spectrometry combined with enzyme digestion or Edman degradation to determine the peptide sequence. The secondary structure of a polypeptide is actually a local structure formed by the peptide chain due to hydrogen bonds. Its confirmation generally includes detection methods such as X-ray single crystal diffraction, nuclear magnetic resonance, infrared, ultraviolet, and circular dichroism.

High-performance liquid chromatography (HPLC) is the main method for the identification, separation and quantification of peptides and their related impurities. The development of long-acting formulations of Exenatide includes PEG derivatives and dimerized Exenatide, microsphere injections, etc.


Omizzur Biotech is a custom peptide synthesis company in China. Omizzur provides a series of customized synthesis services for exenatide impurities, as well as analysis reports ,certificates for HPLC, MS, COA, COO,BSE, etc. Omizzur sign a customer privacy agreement to 100% protect customer privacy . Please contact Omizzur customer services for help.

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