China H&Z® Sitagliptin is approved by the FDA as an adjunct to diet and exercise to improve glycaemic control in patients with T2DM, either as a monotherapy, or in combination with metformin or a peroxisome proliferatoractivated receptor-γ agonist (for example, thiazolidinediones) when the single agent does not provide adequate glycaemic control.
China H&Z® Sitagliptin Factory
Sitagliptin CAS:486460-32-6
Sitagliptin phosphate monohydrate CAS: 654671-77-9
Sitagliptin Chemical Properties
MF:C16H15F6N5O
MW:407.31
Melting point:114.1-115.7°C
Boiling point:529.9±60.0°C(Predicted)
Density:1.61±0.1 g/cm3(Predicted)
Sitagliptin Specification:
Items |
Standards |
Analytical results |
Appearance |
White to off-whitecrystal powder |
white crystal powder |
Identification |
HPLC RT |
Conform |
IR |
Conform |
|
PHOSPHATE |
Conform |
|
Water |
3.3~3.7% |
3.41% |
Residue on ignition |
≤0.2% |
0.02% |
Chiral impurity |
≤0.5% |
0.01% |
Related impurity |
Any individual impurity≤0.1% |
0.01% |
Total impurities≤0.5% |
0.02% |
|
HPLC assay |
98%-102.0% |
100.2% |
Residual solvents |
ND |
|
IPAC≤5000ppm |
ND |
|
Methanol≤3000ppm |
ND |
|
Isopropanol≤5000ppm |
1051ppm |
|
PSD |
95%-100% particle pass through 90 micron seive |
Conform |
60%-80% particle pass through 63 micron seive |
Conform |
|
Conclusion |
Conforms withUSP41standard. |
Sitagliptin Introduction:
H&Z® Sitagliptin is an orally-bioavailable selective DPP4 inhibitor that was discovered through the optimization of a class ofβ-aminoacid-derived DPP4 inhibitors.
It lowers DPP4 activity in a sustained manner following once daily administration, preserves the circulating levels of intact GIP and GLP1 following meals in both acute and chronic studies and reduces blood glucose levels without significant increases in hypoglycaemia.
Sitagliptin Advantage and application:
Clinical studies have shown that cetagliptin is an effective oral drug with good market prospects. It has significant hypoglycemic effects when used alone or in combination with metformin and pioglitazone, and it is safe to take, well tolerated and has few adverse reactions