Semaglutide is a synthetically engineered analogue of human glucagon-like peptide-1 (GLP-1) that exerts its effects by activating the GLP-1 receptor. GLP-1 is an incretin hormone secreted by L cells located in the distal ileum and colon. The structure of semaglutide has been modified based on native GLP-1 to resist enzymatic degradation and to enable strong binding to serum albumin in the bloodstream. Activation of the GLP-1 receptor stimulates insulin secretion and suppresses glucagon release, thereby effectively regulating blood glucose levels. In addition, it delays gastric emptying and reduces appetite, contributing to body-weight control.
Research Applications:
-Type 2 diabetes treatment
-Weight management studies
-Cardiovascular risk reduction research
Product parameters
| 检测项目 Tests |
接受标准 Acceptance Criteria |
结果 Results |
|
| 溶解性 Solubility |
可溶于纯水中，浓度达 5 mg/ml Can be dissolved to 5mg/ml in pure water |
符合 Confirms |
|
| 分子离子质量 Molecular Ion Mass |
4113.6 ±1.0 | 符合 Confirms |
|
| pH | 7.0–9.0（C = 5 mg/ml） | 7.5 | |
| 水分含量（KF） Water Content (KF) |
不得超过 8.0% NMT 8.0% |
2.60% | |
| 纯度（HPLC） Purity (HPLC) |
不得低于 99.0% NLT 99.0% |
99.25% | |
| 有关物质（HPLC） Related substances (HPLC) |
最大单一杂质含量不得超过 0.5% The largest individual impurity test NMT 0.5% |
0.31% | |
| 总杂质含量不得超过 1.0% The total impurities test NMT 1.0% |
0.75% | ||
| 残留溶剂（GC） Residual solvent (GC) |
二氯甲烷 Methylene chloride |
不得超过 600 ppm NMT 600 ppm |
未检出 N.D |
| 乙腈 Acetonitrile |
不得超过 410 ppm NMT 410 ppm |
177 ppm | |
| 甲醇 Methanol |
不得超过 3000 ppm NMT 3000 ppm |
未检出 N.D |
|
| N,N-二甲基甲酰胺 N,N-Dimethylformamide |
不得超过 880 ppm NMT 880 ppm |
未检出 N.D |
|
| 异丙醚 Isopropyl ether |
不得超过 5000 ppm NMT 5000 ppm |
未检出 N.D |
|
| 三乙胺 Triethylamine |
不得超过 320 ppm NMT 320 ppm |
未检出 N.D |
|
| 叔丁基甲基醚 Tert-butyl methyl ether |
不得超过 5000 ppm NMT 5000ppm |
未检出 N.D |
|
| 酸性基团离子（HPLC） Acid group ions (HPLC) |
三氟乙酸（TFA） | 不得超过 0.1% NMT 0.1% |
未检出 N.D |
| 磷酸根（PO₄³⁻） | 不得超过 0.1% NMT 0.1% |
未检出 N.D |
|
| 乙酸（HAC） | 不得超过 0.1% NMT 0.1% |
未检出 N.D |
|
| 微生物限度 Microbial Limits |
需氧菌总数 TAMC |
不得超过 1000 cfu/g | 符合 Confirms |
| 酵母和霉菌总数 TYMC |
不得超过 100 cfu/g | 符合 Confirms |
|
| 大肠杆菌存在性 Escherichia Coil presence |
阴性 Negative |
符合 Confirms |
|
| 沙门氏菌 Salmonella |
阴性 Negative |
符合 Confirms |
|
| 铜绿假单胞菌 P. Aeruginosa |
阴性 Negative |
符合 Confirms |
|
| 金黄色葡萄球菌 S. Aureus |
阴性 Negative |
符合 Confirms |
|
| 钠离子 Sodium ion |
不得超过 4.0% NMT 4.0% |
3.40% | |
| 细菌内毒素 Bacterial Endotoxins |
不得超过 10 EU/mg NMT 10 EU/mg |
符合 Confirms |
|
| 含量（UPLC） Assay (UPLC) |
≥95.0% | 98.50% | |
| 存储 Storage |
保持在密闭容器中，避光保存，储存温度为 -20±5℃ Keep in tight container, protect from light, store at a temperature of -20±5℃ |
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