| 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 |