Description
Dapagliflozin is a new type of antidiabetic drug jointly developed by Bristol-Myers Squibb and AstraZeneca. It was approved by the European Medicines Agency (EMA) on November 12, 2012 and is the first to be approved. SGLT2 inhibitors for the treatment of type 2 diabetes are important candidates for the treatment of diabetes. They are used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
| Product Name | Dapagliflozin | |
| Reference | USDMF standard | |
| Test Items | Specifications | Results |
| Appearance | Off-white to yellowish powder | Off-white powder |
| Identification | 1) Infrared absorption spectrum corresponds to the spectrum obtained with Dapagliflozin RS. | Conforms |
| 2) The retention time of the major peak of sample solution corresponds to that of the standard solution, as obtained in the assay. | Conforms | |
| Water | 3.4%-4.3% | 3.6% |
| Residue on ignition | ≤0.1% | <0.1% |
| Related substances (HPLC) | Five-membered heterocyclic impurity≤0.15% | <LOD(LOD=0.01%) |
| α-isomer≤0.15% | <LOD(LOD=0.01%) | |
| Any unspecified impurity≤0.10% | <LOD(LOD=0.01%) | |
| Total impurities≤1.0% | <LOD | |
| Genotoxic impurity(LC/MS) | Methyl methanesulfonate≤60ppm | <LOD(LOD=7,Oppm) |
| Assay (HPLC) | 98.0% -102.0% (Calculated on anhydrous and solvent-free basis) | 99.5% |
| (S)-1,2-propanediol (GC) | 13.6%-16.6% | 13.8% |
| Residual solvents (GC) | Dichloromethane≤600ppm | <LOD(LOD=54ppm) |
| Ethyl acetate≤5000ppm | <LOD(LOD=15ppm) | |
| Ethanol≤5000ppm | <LOQ(LOQ=250ppm) | |
| Toluene≤890ppm | <LOD(LOD=9ppm) | |
| Methanol≤3000ppm | <LOD(LOD=81ppm) | |
| n-heptane≤5000ppm | <LOD(LOD=2ppm) | |
| Tertrahydrofuran≤720ppm | <LOD(LOD=8ppm) | |
| Cyclohexane≤3880ppm | 34ppm | |
| Isopropyl acetate≤5000ppm | 104ppm | |
| Conclusion | Complies with USDMF standard | |
