Dulaglutide

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.