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Semaglutide Powder is a novel GLP-1 (glucagon like peptide-1) analogue developed by Dunno and Novo Nordisk. Ozempic is a long-acting dosage form based on the basic structure of liraglutide, which has good efficacy in the treatment of type 2 diabetes. Natural semaglutide is a GLP-1 analog that was approved by the US Food and Drug Administration in June 2021. Novo Nordisk has completed six pchaseiia studies on Sermaglutide injection and submitted a new drug registration application for weekly injection of Sermaglutide to the US Food and Drug Administration (FDA) on December 5, 2016, as well as a marketing authorization application to the European Medicines Agency (EMA). On the other hand, the daily oral preparation of somalatide is currently in clinical phase III.
Shanxi BLOOM Tech Co., Ltd. has semaglutide for sale. If you would like to know about the semaglutide price, please send us an email. Shaanxi BLOOM Tech Co., Ltd. not only provides customized ozempic peptides, but also offers semaglutide with bpc 157. In the chemical industry, both bpc 157 and semaglutide belong to the peptide series, while semaglutide and aod 9604 also belong to the same peptide series. Therefore, Shaanxi BLOOM Tech Co., Ltd. can provide customization. It was developed by Novo Nordisk to enhance the biological activity and stability of GLP-1 in vivo by simulating its amino acid sequence. Compared with natural GLP-1, Semalutide has a longer half-life and higher biological activity, which makes it a promising drug for the treatment of diabetes.
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Semaglutide Powder COA
Treatment of diabetes
Ozempic peptide is a long-acting GLP-1 receptor agonist that can lower blood sugar levels by simulating the effects of insulin-like peptide-1 (GLP-1) produced in the body. It can stimulate the secretion of insulin, inhibit the secretion of Glucagon, and slow the emptying speed of gastrointestinal tract, thus reducing the rise of blood sugar after food intake. The long-lasting nature allows it to be injected once a week to provide continuous blood sugar control.
Weight management
Clinical trials have shown that obese patients treated with Semaglutide can significantly reduce weight compared to placebo. It works by inhibiting appetite and increasing satiety, thereby reducing energy intake. Therefore, it is considered a potential tool for treating obesity.
Cardiovascular protection
In the cardiovascular safety trial, the risk of cardiovascular events (such as heart attack and stroke) in diabetes patients treated with it was significantly lower than that of placebo. This indicates that Semalutide may have the effect of reducing the risk of cardiovascular disease, which may be related to improving insulin resistance, reducing insulin resistance and improving blood fat metabolism.
Lipid metabolism disorders
Improving lipid metabolism, reduce triglycerides and cholesterol levels in the blood. This is particularly important for patients with diabetes, because they are usually accompanied by abnormal lipid metabolism.
It should be noted that although semaglutide powder has been proven to have the aforementioned effects in clinical trials, it still needs to be used under the guidance of a doctor and follow relevant dosage and usage guidelines. In addition, the use may vary slightly depending on the approval situation in different countries or regions.
Pharmacodynamic principle: the interaction between semaglutide and GLP-1 receptor is mediated, increasing cyclic adenosine monophosphate (cAMP), which can stimulate insulin secretion in a glucose concentration-dependent mode and reduce excessive glucagon secretion in a glucose concentration-dependent mode. Therefore, insulin secretion is stimulated when blood glucose rises and glucagon secretion is inhibited. In contrast, liraglutide reduces insulin secretion during hypoglycemia without affecting glucagon secretion. It could also slightly prolong the gastric emptying time, and the dosage was 3mg without QTc prolongation. In vitro experiments confirmed that somaluride did not inhibit or induce CYP enzymes, nor did it interact with drug transporters. It can cause delayed gastric emptying. When used with oral drugs, it can reduce the absorption rate and degree of oral medications. There is no interaction between semaglutide, metformin, atorvastatin, warfarin, digoxin, and oral contraceptives.
It has a broad market. As one of the top ten chronic diseases in the world, diabetes is a metabolic disease characterized by chronic hyperglycemia. Diabetes patients mainly type II patients, and type II diabetes patients account for more than 90%. According to the International Diabetes Federation (IDF) statistics, by the end of 2017, 425million adults worldwide had had diabetes. It is estimated that by 2045, the number of patients worldwide will reach 629million. The prevalence of diabetes in China has exceeded the global average. In 2017, the number of people who have diabetes came 114million. According to the world's top, it is expected to increase to about 150million by 2045.
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, and the analytical method of its active pharmaceutical ingredient (Semaglutide Powder) is crucial for ensuring the quality, safety and efficacy of the drug. The following will provide a detailed introduction to the analytical methods of semaglutide API, including molecular weight determination, purity analysis, impurity detection, and stability studies, among other aspects.
Molecular Weight Determination
Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) is a common method for determining the molecular weight of semaglutide. This method features fast analysis speed, simple and intuitive results, wide range of analysis quality, and easy operation. It is highly suitable for the analysis of molecular weight and impurities of peptide drugs. In the synthesis process of semaglutide, the confirmation of the molecular weight of the synthetic precursor, synthetic intermediate and final product is a key quality control link. Through MALDI-TOF MS, the molecular weight of semaglutide and its related compounds can be determined rapidly and accurately to ensure that the products meet the quality standards.
For example, the MALDI-8030 is a compact desktop bipolar MALDI-TOF mass spectrometer that has the same performance as traditional large MALDI-TOF mass spectrometers in linear mode. Rapid detection can be carried out by adopting a 200 Hz solid-state laser and replacing the sample target plate (loading and locking chamber) while maintaining the vacuum degree of the detection area. In addition to being equipped with a fully automatic ion source cleaning device, it also adopts an oil-free diaphragm pump design, which requires less maintenance, is easy to use, and has a wide molecular weight detection range. It is suitable for molecular weight detection and impurity analysis of various samples under the MALDI source.
Purity Analysis
High performance liquid chromatography (HPLC) is the main method for the purity analysis of semaglutide active pharmaceutical ingredients. HPLC has the advantages of high sensitivity, high resolution and high repeatability, and can accurately determine the purity of semaglutide. In HPLC analysis, reversed-phase chromatographic columns are usually adopted, with methanol-water or acetonitrile-water as the mobile phase, and semaglutide and its impurities are separated by gradient elution. The absorption peaks of each component are detected by detectors (such as ultraviolet detectors or fluorescence detectors), and the purity of semaglutide is calculated based on the peak area or peak height.
In addition, liquid chromatography-tandem mass spectrometry (LC-MS/MS) can also be used for the purity analysis of semaglutide. LC-MS/MS has the characteristics of high sensitivity, high selectivity and high throughput. It can distinguish the original form of drugs from complex metabolites, and there is no need to prepare additional antibodies or radioisotope-labeled compounds. In the purity analysis of semaglutide, LC-MS/MS can detect extremely low concentrations of impurities, ensuring that the purity of the product meets the quality standards.
Impurity Detection
Impurities in semaglutide active pharmaceutical ingredients may include by-products during the synthesis process, degradation products, and residual solvents, etc. The presence of these impurities may affect the safety and efficacy of the drug, so strict testing and control are required.
HPLC is one of the main methods for impurity detection. Effective separation of semaglutide from impurities can be achieved by optimizing chromatographic conditions, such as the composition of the mobile phase, gradient elution procedures, column temperature, etc. The absorption peaks of each component are detected by the detector, and the type and content of impurities are determined based on the retention time and peak shape.
Mass spectrometry (MS) technology can also be used for impurity detection. Through the fragment ion information of MS, the chemical structure of impurities can be determined, providing a basis for the analysis of impurity sources. In the impurity detection of semaglutide, the HPLC-MS combined technology is often adopted, which combines the separation ability of HPLC with the qualitative ability of MS to improve the accuracy and reliability of impurity detection.
In addition, nuclear magnetic resonance (NMR) technology can also be used for the structural confirmation and impurity detection of semaglutide active pharmaceutical ingredients. NMR can provide information on the chemical environment of atomic nuclei in a molecule. By analyzing the NMR spectrum, the chemical structure of semaglutide can be determined and the presence of trace impurities can be detected.
Stability Research
The stability study of semaglutide API is of great significance for evaluating the quality changes of the drug under different conditions. Stability studies usually consist of two parts: accelerated tests and long-term tests.
Accelerated tests are conducted under harsh conditions such as high temperature and high humidity to accelerate the degradation process of drugs and evaluate their short-term stability. In the accelerated test, samples were taken regularly to determine the content, purity and changes of related substances of semaglutide, and the stability of the drug was evaluated based on the test results.
Long-term trials are conducted under conditions close to the actual storage of the drug to assess its long-term stability. In long-term trials, it is also necessary to take samples regularly to determine various quality indicators of semaglutide and observe the changes in drug quality over time.
In stability studies, in addition to conventional analytical methods such as HPLC and LC-MS/MS, technical means such as differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) can also be adopted to study the changes in physical properties such as thermal stability and melting point of semaglutide. These technical means can provide a scientific basis for the storage conditions of semaglutide.
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