Glucagonlikepeptide-1 (GLP-1) is a hormone secreted by intestinal L cells, which belongs to incretin and can promote the secretion of insulin by pancreatic islet β cells in a glucose concentration-dependent manner. GLP-1 analogue is a new product developed since the new century, and it is currently one of the hot spots of drug research and development, among which the sales of liraglutide and semaglutide are extremely bright, which has attracted many pharmaceutical companies to go down the market.
However, in the production and processing process of biological fermentation technology, polyoxyethylene, polyoxypropylene, pentaerythritol ether, etc. will be added as defoamers. Oxyethylene polyoxypropylene pentaerythritol ether, chemical formula C[CH2O(C2H4O)n(C3H6O)mH]4, alias PPE, colorless transparent oily liquid, insoluble in water, miscible with organic solvents such as low fatty alcohols, ether, acetone, benzene, toluene, aromatic compounds, insoluble in mineral oil such as kerosene, good thermal stability, often used as a defoamer in the fermentation process.
In order to solve the residue of polyoxyethylene polyoxypropylene pentaerythritol ether defoamer in the GLP-1 analogue sample, the method was developed and validated by UPLC-MS/MS ultra-performance liquid chromatography tandem mass spectrometry. Combining the powerful separation capabilities of ultra-performance liquid chromatography and the high sensitivity and specificity of mass spectrometry in qualitative and quantitative analysis, the final detection method has high sensitivity, strong selectivity and good repeatability, which is suitable for the analysis of polyoxyethylene polyoxypropylene pentaerythritol ether defoamer residues in samples, and has practical significance for its quality control.
Polyoxyethylene polyoxypropylene pentaerythritol ether has excellent emulsifying properties and can emulsify oil and water mixtures into stable emulsions. Its emulsifying ability relies on multiple polyoxyethylene and polyoxypropylene segments in the molecule, which can form a wrap with the oil molecules, dispersing the oil molecules in water to form a stable emulsion. As a chemical raw material commonly used in modern industrial production, the main role of defoamer is to eliminate the foam caused by surfactants, stirring or other factors in the production process, but there is no doubt that new ingredients are introduced in the process.
The microsource testing laboratory has rich project experience in defoamers and other biopharmaceutical process residue projects, and can successfully develop defoamers (such as dimethicone, polysorbate, poloxamer 188, trilaton), buffer system components (such as trimethylolaminomethane), process enhancers and catalysts (methionine sulfoxide, ethylenediaminetetraacetic acid, polyethylene glycol) by using ICP-OES inductively coupled plasma emission spectrometer, LC-CAD liquid chromatography, LC-MS liquid chromatography-mass spectrometry, etc. and other process residue analysis methods, the detection limit can reach the ppm level.
The laboratory testing engineers have rich experience in providing suitable impurity detection solutions for biomedical industry workers and scientific researchers, and at the same time follow the guiding principles for method verification (specificity, precision, sensitivity, detection limit, quantitative limit, linearity and range, accuracy, repeatability, durability, etc.), to meet the development and detection of defoamer residue methods for different enterprises and different projects, the detection and removal of defoamers in different purification stages, and the method verification of defoamer residues at different declaration stages. Welcome to send samples for consultation!
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