Peptide Drug Residue Solvent Analysis

Peptide drugs are bioactive molecules formed by the connection of multiple amino acids through peptide bonds. Typically, they are composed of 10-100 amino acids, with a relative molecular weight less than 10,000. Most peptide drugs are derived from endogenous peptides or natural peptides, so they have little or no side effects on the human body. Compared with protein drugs, peptide drugs also have advantages such as good stability, high purity, low production cost, and low immunogenicity. Coupled with the rapid development and maturity of peptide synthesis technology, peptide drugs have become the focus of biological drug research in recent years. Currently, peptide drugs are widely used in the diagnosis and treatment of tumors, autoimmune diseases, certain cardiovascular diseases, diabetes, etc., and have broad application prospects.

 

In the production of peptide drugs, organic solvents such as ethanol, acetone, and dichloromethane are often used. These solvents may remain in the final pharmaceutical product during the production process, referred to as "residual solvents". The presence of residual solvents can not only affect the quality and stability of the drug, but some solvents may also have potential toxic effects on the human body. Therefore, analyzing residual solvents in peptide drugs is an important part of drug quality control. The analysis of residual solvents in peptide drugs has also become one of the research hotspots of peptide drug analysis.

 

Residual solvent analysis is a type of analysis that detects and quantifies solvents that may be present in drugs. This usually includes gas chromatography and high-performance liquid chromatography. Among them, gas chromatography is the most commonly used method for residual solvent analysis. This method uses the volatility of solvents at different temperatures to separate the solvents in the samples and detect and quantify them through detectors. In addition, there are other analysis methods, such as infrared spectroscopy and nuclear magnetic resonance, which can provide structural information about the solvent to assist in its identification and quantification.

 

MtoZ Biolabs provides customers with drug quality research services that comply with global pharmaceutical regulations. We provide a one-stop service for peptide drug residual solvent analysis. All you need to do is tell us your experimental purpose and send the samples. MtoZ Biolabs is responsible for all subsequent project steps, including sample processing, on-machine analysis, data analysis, and project reporting.