99% Purity Pharmaceutical Intermediate Weight Loss Peptide Semaglutide

• CAS No.: 910463-68-2, 2023788-19-2
• Formula: C187h291n45o59
• EINECS: 203-405-2
• Type: Pharmaceutical Intermediates
• Appearance: Powder
• Quality: Technical
• Model NO.: Semaglutide
• Colour: White
• Transport Package: Bag, Drum
• Specification: 1g/bag
• Trademark: Arshine
• Origin: China
• Production Capacity: 100 Kg/Month

Product Description

Factory Direct Peptides  CAS 910463-68-2 Semaglutide Powder

 

Description

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