Linaclotide is a synthetic 14-amino-acid cyclic peptide and a guanylate cyclase-C (GC-C) agonist. By activating GC-C receptors on intestinal epithelial cells, linaclotide increases cGMP levels, enhances chloride and water secretion, and accelerates intestinal transit. It is used to relieve constipation-related disorders, including irritable bowel syndrome with constipation and chronic or functional constipation.
Research Applications:
- Regulating intestinal fluid secretion studies
- Support gastrointestinal motility.
- Helps improve bowel movement frequency and stool consistency.
- Manage constipation-related digestive conditions under medical guidance.
| 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 |
1526.7 ± 1.0 | 符合 Conforms |
|
| 溶解度 Solubility |
在纯水中可溶解至浓度为 2 mg/ml Can be dissolved to 2 mg/ml in pure water |
符合 Conforms |
|
| 酸碱度 pH |
4.0~6.0 | 4.8 | |
| 水分（K.F） Water Content (K.F) |
≤ 8.0% | 2.40% | |
| 纯度（UPLC） Purity (UPLC) |
≥ 99.0% | 99.17% | |
| 有关物质（UPLC） Related Substance (UPLC) |
总杂 Total impurities |
≤ 1.0% | 0.83% |
| 最大单一杂质 Largest individual impurity |
≤0.5% | 0.19% | |
| 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 | 120 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 |
≤ 5.0% | 3.80% | |
| 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% | 99.10% | |
| 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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