Semaglutide impurities is various impure substances that may be generated during the preparation of Semaglutide . The sources of these impurities can be attributed to three aspects: impurities introduced by starting materials, process related impurities, and impurities generated by degradation.

Semaglutide impurities, including impurities introduced from starting materials, process related impurities, and impurities generated by degradation, require targeted research on impurities introduced from potentially hydrolyzable and racemic amino acids.

Semaglutide Impurities Research

The study of impurities in semaglutide is an important step in ensuring product quality and safety. By conducting targeted research on impurities introduced from starting materials, process related impurities, and impurities generated during degradation, the production of impurities can be effectively controlled and reduced, and the purity and quality of products can be improved. 

At the same time, specialized research and control are needed for impurities introduced by amino acids that are potentially prone to hydrolysis and racemization to ensure the stability and effectiveness of the product.

Omizzur Semaglutide Impurities Catalog

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3 Sources of Semaglutide impurities 

Firstly, the impurities introduced by the starting materials refer to the impurities introduced during the preparation of semaglutide due to the impure nature of the starting materials used. These impurities may be by-products generated during the synthesis or extraction of raw materials, or they may be trace impurities in the raw materials. These impurities may have an impact on the quality and purity of the final product, therefore targeted research and control are needed.

Secondly, process related impurities refer to impurities introduced during the preparation of semaglutide due to improper process operation or incomplete equipment. For example, inappropriate reaction conditions may lead to the occurrence of side reactions and the production of unwanted products; Improper operation may lead to issues such as cross contamination. These impurities may have a negative impact on the quality and purity of the product, so it is necessary to optimize and improve the process to ensure the stability and controllability of product quality.

Finally, the impurities generated by degradation refer to the chemical or physical changes that may occur in semaglutide during storage, transportation, or use due to environmental factors such as temperature, humidity, light, etc., resulting in the formation of new impurities. These impurities may affect the stability and activity of the product, so it is necessary to study and control these potential degradation pathways to extend the product's shelf life and ensure its safety and effectiveness.

In addition, targeted research is also needed for impurities introduced by amino acids that are potentially prone to hydrolysis and racemization. These amino acids may undergo hydrolysis or racemization reactions during the synthesis process, resulting in different isomers or derivatives. These impurities may affect the biological activity and stability of the product, therefore detailed research is needed to determine their structure and properties, and corresponding measures should be taken to reduce or remove them.

FAQ: How many structural types are there for peptide impurities?

The impurities related to peptide drugs can be divided into process impurities introduced during the synthesis process, degradation impurities, polymer and optical impurities, etc. During the synthesis of peptides, there are numerous impurities and their components are also relatively complex. The impurities of semaglutide include oxides, polymers, etc., which may affect the stability and safety of semaglutide. Therefore, it is necessary to qualitatively and quantitatively analyze the relevant impurities, reduce impurity interference, improve synthesis and purification efficiency, and further ensure the quality and safety of semaglutide. The following summarizes the mechanism of impurity formation in Semaglutide:

Amino acid deletions and insertions

Fmoc deprotection can cause racemization of amino acid residues, thereby introducing enantiomeric impurities. The inefficient deprotection of amino acid side chains can lead to peptide protected adducts, while unprotected side chains can react with various reagents in the process route;

Peptide degradation mechanism

Typical β - elimination, diketopiperazine, pyroglutamate, and succinimide formation;

Side chain/end chain impurities

Arginine side chain amination produces primary amines, while peptide bond condenser TSTU introduces impurities;

Dimer

Multiple monomers are oxidized to form tyrosine through disulfide bonds or tyrosine oxidation;

Oxidation-reduction

Histidine and lysine are easily oxidized, producing 2-oxohistidine and aminoadipic acid. The tryptophan side chain has strong reactivity under acidic conditions and is easily oxidized;

Degradation products

H+or OH - catalyzes the elimination of C-S bonds in cysteine by α - β, resulting in the formation of new residues;

Residual solvents, etc

Residual N-methylpyrrolidone (NMP), ethyl acetate, dichloromethane, n-hexane, etc. in semaglutide

About Omizzur

Omizzur is a company engaged in custom peptide synthesis, peptide impurities and intermediates, fmoc/boc- amino acid derivatives, committed to providing professional peptide synthesis services for global pharmaceutical research and development enterprises. Thanks to Omizzur's mature peptide synthesis technology, it currently has a significant cost advantage in synthesizing peptides and amino acids. Omizzur Biotech mainly engages in the following areas of business:

Custom Peptide Synthesis Service

Peptide Intermediates and impurities Synthesis

Fmoc/boc/cbz-amino acids

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