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| Cas No.: | 923950-08-7 |
| pH value: | Corresponds to reference standard： PASS |
| Non-reduced CE-SDS: | 98.1% |
| SEC-HPLC: | 99.4% |
| Isoelectric Point: | Corresponds to reference standard:PASS |
| Bacterial Endotoxins Test: | ＜1 EU/ml |
| Exogenous Residual DNA: | ＜1 pg/mg |
| Residual protein A: | ＜1 ng/mg |
| Biological Activity: | Compared with standard, the range of biological activity is 103% |
| Osmolality: | Corresponds to reference standard: PASS |
| Peptide mapping: | Corresponds to reference standard: PASS |
| N-terminal sequence: | Corresponds to reference standard:PASS |
| Description: | Dulaglutide (LY2189265) is a glucagon-like peptide-1 (GLP-1) receptor agonist. Sequence: His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Glu-Gln-Ala-Ala-Lys-Glu-Phe-Ile-Ala-Trp-Leu-Val-Lys-Gly-Gly-Gly;HGEGTFTSDVSSYLEEQAAKEFIAWLVKGGG. |
| Target: | GLP-1 receptor[1] |
| In Vivo: | Dulaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. No specific Dulaglutide-related cause of death is identified. Survival is numerically increased for both genders of animals in all Dulaglutide treatment groups and reaches statistical significance (P≤0.05) in the 0.5- and 5-mg/kg males and in the 0.05-, 0.5-, and 1.5-mg/kg females. Mean times to peak plasma concentration values of Dulaglutide are observed at 12 hours after dosing on day 1 and rang between 12 and 48 hours at week 52. The incidence of thyroid C-cell adenoma is significantly (P≤0.05) increased compare with controls in males and females at the Dulaglutide 0.5-, 1.5-, and 5-mg/kg doses[1]. |
| Animal Administration: | The tumorigenic potential of Dulaglutide is evaluated in rats and transgenic mice. Rats are injected sc twice weekly for 93 weeks with Dulaglutide 0, 0.05, 0.5, 1.5, or 5 mg/kg corresponding to 0, 0.5, 7, 20, and 58 times, respectively. Transgenic mice are dosed sc twice weekly with Dulaglutide 0, 0.3, 1, or 3 mg/kg for 26 weeks[1]. |
| References: | [1]. Byrd RA, et al. Chronic Toxicity and Carcinogenicity Studies of the Long-Acting GLP-1 Receptor AgonistDulaglutide in Rodents. Endocrinology. 2015 Jul;156(7):2417-28. |