Manufacturer Trelagliptin Succinate SYR-472 Powder Anti-diabetic Drugs for Type 2 Diabetes
Trelagliptin Succinate Specification
Product Name: Trigliptin succinate
CAS: 1029877-94-8
Standard: Corporate Standard
Natural/Synthetic: Synthetic
Source of extraction: For scientific research only
Level: Pharmaceutical grade
Content: 99%
Appearance: white powder
Packing: 1KG/aluminum foil bag
Ingredients: 2-[[6-[(3R)-3-amino-1-pyridine]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidine] Methyl]-4-fluoro-benzonitrile succinate
Physical and chemical properties: white to white crystalline powder
Category: Pharmaceutical Raw Materials
Industry: Pharmaceuticals
Field: Hypotensive hypoglycemic agents
Deferred products: tetagliptin succinate tablets
Use: For Type 2 diabetes, a weekly dipeptidyl peptidase IV (DPP-4) inhibitor that selectively and persistently inhibits DPP-4 and controls blood glucose levels. DPP-4 is an enzyme that triggers the inactivation of incretins (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)), which intestines lower blood sugar Regulation plays an important role.Inhibiting DPP-4 can increase blood glucose level-dependent insulin secretion and thus control blood glucose levels.
Usage and dosage: Oral administration of tutrigliflozin 100 mg once a week for adults.
Trelagliptin Succinate Certificate of Analysis
| Product name |
Trelagliptin Succinate |
| CAS No. |
1029877-94-8 |
Outer Packing |
1kg/foil bag |
| Production date |
2018.02.06 |
Shelf life |
2020.02.05 |
| Standard adopted |
Enterprise Standard |
| Items of analysis |
Specification |
Results |
| Appearance |
White to off-white crystalline powder |
White crystalline powder |
| Solubility |
This product is soluble in dimethyl sulfoxide or water, slightly soluble in methanol, slightly soluble in absolute ethanol, very slightly soluble in acetonitrile, almost insoluble in dichloromethane. |
Conforms |
| Melting point |
184～189℃ |
185～188℃ |
| Specific rotation |
+17°~ +23° |
+22° |
| HPLC |
The retention time of the main peak of the test solution should be the same as the retention time of the main peak of the reference solution. |
Conforms |
| IR |
This product’s infrared absorption spectrum should be consistent with the reference map |
Conforms |
| Chloride |
≤0.02% |
Conforms |
| Max single Impurty |
≤0.1% |
0.07% |
| Total impurities |
≤0.40% |
0.15% |
| Corresponding isomers |
≤0.50% |
N D |
| Ethanol |
≤0.5% |
0.015% |
| Dichloromethane |
≤0.06% |
N D |
| Toluene |
≤0.089% |
N D |
| Moisture |
≤0.5% |
0.13% |
| Residue on ignition |
≤0.1% |
Conforms |
| Heavy metal |
≤20 parts per million |
Conforms |
| Assay |
In terms of anhydrous, C18H20FN5O2·C4H6O4 should be 98.5% to 101.5% |
99.8% |
| Conclusion |
Qualified |
What is Trelagliptin Succinate?
Trelagliptin, also known as SYR-472, is a long acting dipeptidyl peptidase-4 (DPP-4) inhibitor that is being developed by Takeda for the treatment of type 2 diabetes (T2D).
Once-weekly SYR-472 treatment produced clinically and statistically significant improvements in glycaemic control in patients with type 2 diabetes. It was well tolerated and might be a new treatment option for patients with this disease. Trelagliptin (Zafatek) was approved in Japan for the treatment of type 2 diabetes mellitus.
