Cagrilintide is a long-acting and stable analogue of amylin. Amylin is a naturally occurring peptide that regulates food intake and metabolism. By activating amylin receptors (AMYRs), it induces satiety and helps prevent overeating, thereby reducing energy intake. At the same time, it can increase energy metabolism and reduce adipose tissue mass.
Research Applications:
– Long-acting amylin analog
– Obesity treatment research
– Type 2 diabetes management
| 检测项目 Tests |
接受标准 Acceptance Criteria |
结果 Results |
|
| 溶解性 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 Confirms |
|
| 分子离子质量 Molecular Ion Mass |
4409.1 ± 1.0 | 符合 Confirms |
|
| 水分含量（KF） Water Content (KF) |
不得超过 8.0% NMT 8.0% |
2.20% | |
| 纯度（HPLC） Purity (HPLC) |
不得低于 99.0% NLT 99.0% |
99.23% | |
| 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% |
0.34% | |
| 总杂质含量不得超过 1.0% The total impurities test NMT 1.0% |
0.77% | ||
| 残留溶剂（GC） Residual solvent (GC) |
二氯甲烷 DCM |
不得超过 600 ppm NMT 600 ppm |
未检出 N.D |
| 乙腈 ACN |
不得超过 410 ppm NMT 410 ppm |
122 ppm | |
| 甲醇 MetOH |
不得超过 3000 ppm NMT 3000 ppm |
未检出 N.D |
|
| N,N-二甲基甲酰胺 DMF |
不得超过 880 ppm NMT 880 ppm |
未检出 N.D |
|
| 叔丁基甲醚 Isopropyl ether |
不得超过5000 ppm NMT 5000 ppm |
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 |
|
| 醋酸根（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 |
≤ 1000 cfu/g | 符合 Confirms |
| 酵母和霉菌总数 TYMC |
≤ 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 |
|
| 钠离子（IC） Sodium Ion (IC) |
≤2.0% | 1.40% | |
| 细菌内毒素 Bacterial Endotoxins |
≤ 10 EU/mg | 符合 Confirms |
|
| 含量（UPLC） Assay (UPLC) |
≥ 95.0% | 98.80% | |
| 存储 Storage |
保存在密闭容器中，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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