BI-456906 (Survodutide) is a balanced and potent dual agonist of the glucagon receptor (GCGR) and the GLP-1 receptor (GLP-1R), derived from the natural gut hormone oxyntomodulin. By suppressing appetite and delaying gastric emptying (via GLP-1R) while increasing energy expenditure (via GCGR), Survodutide achieves significant weight reduction and simultaneously maintains or improves blood glucose control.
Research Applications:
- Activates GLP-1 and glucagon pathways to support metabolic regulation.
- Helps reduce appetite and slow gastric emptying.
- Supports increased energy expenditure under controlled conditions.
- Investigated for weight management and metabolic health applications.
| 项目 Items | 标准 Standard | 结果 Results | |
| 外观 Appearance |
白色或类白色粉末 White or off-white powder |
白色粉末 White powder |
|
| 分子量 Molecular Ion Mass |
4231.6 ± 1.0 | 符合 Conforms |
|
| 溶解度 Solubility |
在纯水中可溶解至浓度为 50 mg/ml Can be dissolved to 50 mg/ml in pure water |
符合 Conforms |
|
| 酸碱度 pH |
7.0–9.0 | 7.6 | |
| 水分(K.F) Water Content (K.F) |
≤ 8.0% | 3.60% | |
| 纯度(UPLC) Purity (UPLC) |
≥ 99.0% | 99.36% | |
| 有关物质(UPLC) Related Substance (UPLC) |
总杂 Total impurities |
≤ 1.0% | 0.64% |
| 最大单一杂质 Largest individual impurity |
≤0.5% | 0.17% | |
| 残留溶剂(GC) Residual Solvent (GC) |
二氯甲烷 Methylene chloride |
≤ 600 ppm | 未检出 N.D |
| 乙腈 Acetonitrile |
≤ 410 ppm | 136 ppm | |
| 甲醇 Methanol |
≤ 3000 ppm | 未检出 N.D |
|
| N,N-二甲基甲酰胺 N,N-Dimethylformamide |
≤ 880 ppm | 未检出 N.D |
|
| 叔丁基甲醚 Isopropyl ether |
≤ 5000 ppm | 未检出 N.D |
|
| 酸根离子(IC) Acid Group Ions (IC) |
三氟乙酸 TFA |
≤ 0.1% | 未检出 N.D |
| 磷酸根 PO₄³⁻ |
≤ 0.1% | 未检出 N.D |
|
| 醋酸根 HAC |
≤ 0.1% | 未检出 N.D |
|
| 钠离子(IC) Sodium Ion (IC) |
≤ 4.0% | 3.30% | |
| 微生物限度 Microbial Limits |
需氧微生物总数 TAMC |
≤ 1000 cfu/g | 符合 Conforms |
| 酵母和霉菌总数 TYMC |
≤ 100 cfu/g | 符合 Conforms |
|
| 细菌内毒素 Bacterial Endotoxins |
≤ 10 EU/mg | 符合 Conforms |
|
| 含量测定(UPLC) Assay (UPLC) |
≥ 95.0% | 99.20% | |
| 储存 Storage |
保存至密闭容器中,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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