Product name | Sitagliptin Phosphate |
CAS No. | 654671-78-0/ 654671-77-9 |
Molecular Formula | C16H18F6N5O5P |
Molecular Weight | 505.31 |
Quality Standard | 98.5% up by HPLC |
Appearance | White powder |
COA of Sitagliptin Phosphate |
ITEMS | STANDARDS | RESULTS |
Appearance | White or off-white crystalline powder | Complies |
Identification | A. Sitagliptin phosphate in water display discriminate reaction of phosphate. B. HPLC: RRT test solution is similar to RRT reference solution. C. IR: Similar to Reference Substance | Complies
Complies
Complies
|
Related substance | XG-E ≤0.15% | N.D. |
XG-F ≤0.15% | N.D. |
XG-G ≤0.15% | N.D. |
XG-H ≤0.15% | N.D. |
XG-K ≤0.15% | N.D. |
XG-L ≤0.15% | 0.01% |
XG-M ≤0.15% | N.D. |
XG-N ≤0.15% | N.D. |
Other individual impurity ≤0.10% | N.D. |
Total impurities ≤0.5% | 0.01% |
Isomer | XG-A ≤0.15% | N.D. |
Water | 3.0%~4.5% | 3.6% |
Residual solvents | Isopropyl alcohol ≤0.5% | 0.02% |
Methyl tert-bytyl ether ≤0.5% | N.D. |
Acetoacetate ≤0.5% | N.D. |
Dimethylformamide ≤0.088% | N.D. |
Heavy metals | ≤ 10ppm | Complies |
Assay | ≥98.5% on anhydrous basis | 100.3% |
Conclusion | Conforms to enterprise standard
|
Function of Sitagliptin Phosphate
Sitagliptin phosphate belongs to the class of Oral antihyperglycemic agents. For patients with type II diabetes, after taking it, it can improve blood sugar by increasing the level of active insulin-stimulating hormone, which can reduce fasting blood sugar, and can also play a role in regulating the level of postprandial blood sugar, so that blood sugar can be controlled at a stable level. status.
1. Monotherapy:
Sitagliptin phosphate, in combination with diet and exercise, is used to improve glycemic control in patients with type II diabetes.
2. In combination with metformin:
When metformin hydrochloride alone has poor glycemic control, sitagliptin phosphate can be used in combination with metformin hydrochloride to improve glycemic control in patients with type II diabetes on the basis of diet and exercise.
