Tirzepatide is a novel dual receptor agonist of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1). Under normal physiological conditions after food intake, the intestine releases endogenous GIP and GLP-1 hormones, which promote insulin secretion, suppress appetite, delay gastric emptying, and enhance satiety. Tirzepatide mimics the actions of these naturally occurring hormones by activating both GIP and GLP-1 receptors in the body.
| 检测项目 Tests | 接受标准 Acceptance Criteria | 结果 Results | |
| 溶解性 Solubility | 可溶于纯水中,浓度达 5 mg/ml Can be dissolved to 5 mg/ml in pure water | 符合 Confirms | |
| 分子离子质量 Molecular Ion Mass | 4813.53 ± 1.0 | 符合 Confirms | |
| pH | 7.0–9.0(C = 5 mg/ml) | 7.6 | |
| 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 98.0% NLT 98.0% | 99.36% | |
| 有关物质(HPLC) Related substances (HPLC) | 最大单一杂质含量不得超过 1.0% The largest individual impurity test NMT 1.0% | 0.19% | |
| 总杂质含量不得超过 2.0% The total impurities test NMT 2.0% | 0.64% | ||
| 残留溶剂(GC) Residual solvent (GC) | 二氯甲烷 Methylene chloride | 不得超过 600 ppm NMT 600 ppm | 未检出 N.D |
| 乙腈 Acetonitrile | 不得超过 410 ppm NMT 410 ppm | 128 ppm | |
| 甲醇 Methanol | 不得超过 3000 ppm NMT 3000 ppm | 未检出 N.D | |
| N,N-二甲基甲酰胺 N,N-Dimethylformamide | 不得超过 880 ppm NMT 880 ppm | 未检出 N.D | |
| 异丙醚 Isopropyl ether | 不得超过 5000 ppm NMT 5000 ppm | 未检出 N.D | |
| 三乙胺 Triethylamine | 不得超过 320 ppm NMT 320 ppm | 未检出 N.D | |
| 叔丁基甲基醚 Tert-butyl methyl ether | 不得超过 5000 ppm NMT 5000ppm | 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 | |
| 乙酸(HAC) | 不得超过 0.1% NMT 0.1% | 未检出 N.D | |
| 细菌内毒素 Bacterial Endotoxins | 不得超过 10 EU/mg NMT 10 EU/mg | 符合 Confirms | |
| 微生物限度 Microbial Limits | 需氧菌总数 TAMC | 不得超过 1000 cfu/g NMT 1000 cfu/g | 符合 Confirms |
| 酵母和霉菌总数 TYMC | 不得超过 100 cfu/g NMT 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 | |
| 金黄色葡萄球菌 S. Aureus | 阴性 Negative | 符合 Confirms | |
| 高分子蛋白 High Molecular Protein | 不得超过 0.50% NMT 0.50% | 未检出 N.D | |
| 钠离子 Sodium ion | 不得超过 5.0% NMT 5.0% | 1.10% | |
| 多肽含量(质量平衡法) Peptide Content (Mass Balance) | 不得低于 80.0% NLT 80.0% | 961.00% | |
| 含量测定(HPLC) Assay (HPLC) | 95.0–105.0%(以无水、无盐基准计) 95.0–105.0% (on anhydrous and salt-free substance basis) | 99.50% | |
