Complaint
Semaglutide is a long-acting analogue of human glucagon-like peptide-1 (GLP-1) receptor. Semaglutide is a long-acting agonist for human glucagon-like peptide-1 (GLP-1) receptor and is clinically available for the treatment of type 2 diabetes.
Semaglutide is also a weight loss drug approved by the US Food and Drug Administration in June 2021, which contains GLP-1 simulant.
Test Items | Specification | Results |
Appearance | White or almost white loose powder | White loose 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 lml.Then, to adjust the pHof 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 rang of pH 3.0 to 5.5 | Conforms |
Identification By HPLC | The retention time of the principal peak of the test solution corresponds to that of the reference solution, as obtained in the Assay | Conforms |
Amino acid contect | Asp:0.9-1.1 Ser:2.7-3.3 Glu:4.5-5.5 Gly:3.6-4.4 His: 0.9-1.1 Arg:1.8-2.2 Thr:1.8-2.2 Ala:2.7-3.3 Aib:0.9-1.1 Tyr:0.9-1.1 Val:1.8-2.2 Lys:0.9-1.1 Ile:0.9-1.1 Leu:1.8-2.2 Phe:1.8-2.2 AEEA:Should be detected | 0.9 3.0 5.0 4.0 1.1 2.2 2.0 3.0 1.0 1.0 1.9 1.0 0.9 2.0 .9 Conforms |
Molecular lon Mass | 4113.58±1.0 | Conforms |
pH | 7.0-9.0 | <8.6 |
Water Content(K. F) | NMT 10.0% | 4.8% |
Solution clarity and color | Clear and colorless | Conforms |
Related substances (HPLC) | Impurity A: NMT 0.3% Impurity D: NMT 0.3% Any individual impurity: NMT0.1% Total impurities: NMT1.5% | N.D 0.01% Any individual impurity: 0.05% Total impurities:0.15% |
Sodium ion | 1.5%-4.0% | 2.8% |
High molecular protein | NMT 0.5% | N.D |
Residual solvent | Methylene chloride NMT 600ppm Acetonitrile NMT 410ppm Methanol NMT 3000ppm DMF NMT 880ppm Isopropyl ether NMT 5000ppm Isopropanol NMT 5000ppm | N.D 20ppm N.D N.D N.D 65ppm |
Bacterial Endotoxins | NMT 50EU/mg | Conforms |
Microbial Limits | TAMC NMT 200cfu/g TYMC NMT 100cfu/g | 10cfu/g 20cfu/g |
Acid group ions | Trifluoroacetate ion NMT 0.1% Phosphate ion NMT 0.1% Chloride ion NMT 0.1% Acetate ion NMT 0.1% | N.D N.D N.D N.D |
Polycyclic Aromatic Hydrocarbon | Pass Test | Pass Test |
Assay | 95.0%-105.0%(Calculated with reference to the anhydrous and salt-free substance.) | 100.6% |
Storage | Preserve in tight containers.Store at a temperature -15ºC to-25ºC | |
Conclusion:This batch of product complies with Enterprise Standard | ||
