Name | Sitagliptin |
Molecular Formula | C16H15F6N5O |
Molecular Weight | 407.32 |
Quality Standard | In house |
Package Size | 1kg/bag or according your requirement |
Brief Introduction | This drug for dipeptide peptidase 4 (DPP - 4) depressants, by protecting endogenous im fall blood sugar, and enhance its role and control blood sugar levels. Glucose dependence on promoting insulin releasing peptide (GIP) and glucagon peptide 1 (glp-1), as for dietary intake and release of intestinal fall blood sugar. |
ITEMS | STANDARDS | RESULTS |
Appearance | White or off-white crystalline powder | Complies |
Identification |
A. Sitagliptin phosphate in water display discriminate reaction of phosphate.
B. HPLC: RRTtest solution is similar to RRTreference 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 toenterprise standard |
Fine Chemicals Sitagliptin Phosphate Hydrate (CAS: 654671-77-9) Chemical information Product Name: Sitagliptin Phosphate Hydrate Synonym: ...