Sermaglutide Cas No.: 910463-68-2 Boiling Point: N/a

Appearance: White or off-white powder; Solubility: Freely soluble in water;
Firstly, to add freshly boiled and cooled water to make a clear solution containing 0.15mg of semaglutide in 1ml. Then, to adjust the pH of the solution to 5.5 with 0.05M hydrochloric acid and keep for 30 seconds. Finally, to adjust the pH of the solution to 3.0 and keep 30 seconds. The solution should be turbid in the range of pH 3.0 to 5.5; Identification (HPLC): As obtained in the Assay, the difference between the retention time of the major peak of the sample solution and the reference solution should be less than 1 minute; Identification (Peptide Mapping): Peptide mapping of sample solution is similar to that of reference solution; Identification (N-terminal amino acid sequence): His-Aib-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu; pH Value: 7.0 8.0; Water Content (K. F): Not more than 8.0%; Related Substances (Hydrophilic Impurities):Not more than 1.5%; Related Substances (Hydrophobic Impurities 1): Not more than 1.0%; Related Substances (Hydrophobic Impurities 2): Not more than 0.2%; Related Substances (Total Impurities): Not more than 2.0%; High Molecular Weight Proteins: Not more than 0.2%; Residual Solvents (Ethanol): Not more than 0.5%; Residual Solvents (Acetonitrile): Not more than 0.041%; Residual Solvents (Dichloromethane): Not more than 0.06%; Biological Activity: Should be 0.7U 1.3U per 1mg; Residual Host Cell Protein: Not more than 100ng/mg; Residual Host Cell DNA: Not more than 10ng/mg; Bacterial Endotoxins: Not more than 10EU/mg; Microbial Limits (Total Aerobic Microbial Count): Not more than 100CFU/g; Microbial Limits (Total Yeasts and Moulds Count): Not more than 100CFU/g; Assay(C187H291N45O59): Containing Semaglutide 0.76mg 1.00mg per 1mg