Teduglutide is a 33-amino-acid synthetic analogue of human GLP-2, modified by one amino acid to resist enzymatic breakdown and prolong activity. Structurally mirroring the intestine-trophic region of GLP-2, it binds GLP-2 receptors on enteroendocrine cells and enteric neurons, promoting the release of growth factors that stimulate mucosal growth, enhance intestinal surface area, increase gut blood flow, and reduce gastric motility and secretion. Teduglutide is used to improve nutrient absorption in patients with short bowel syndrome and to help reduce dependence on parenteral nutrition.
Research Applications:
– Short bowel syndrome treatment
– Intestinal adaptation enhancement
| 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 |
3752.1 ± 1.0 | 符合 Conforms |
|
| 溶解度 Solubility |
在纯水中可溶解至浓度为 5 mg/ml Can be dissolved to 5 mg/ml in pure water |
符合 Conforms |
|
| 酸碱度 pH |
7.0~9.0 | 7.7 | |
| 水分（K.F） Water Content (K.F) |
≤ 8.0% | 3.50% | |
| 纯度（UPLC） Purity (UPLC) |
≥ 99.0% | 99.28% | |
| 有关物质（UPLC） Related Substance (UPLC) |
总杂 Total impurities |
≤ 1.0% | 0.72% |
| 最大单一杂质 Largest individual impurity |
≤0.5% | 0.37% | |
| 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 | 135 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) |
≤5.0% | 3.60% | |
| 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 |
|
| 大肠杆菌 Escherichia Coil |
阴性 Negative |
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% | 99.10% | |
| 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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