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.
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℃ | ||