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Dapagliflozin factory price High purity 99%
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Product Information
Product Name | Dapagliflozin |
CAS | 461432-26-8 |
MF | C21H25ClO6 |
MW | 408.87 |
Density | 1.349 |
Appearance | White Crystalline Powder |
Assay | 98%min |
Usage
Dapagliflozin is indicated for the management of diabetes mellitus type 2, and functions to improve glycemic control in adults when combined with diet and exercise. Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor, which prevents glucose reabsorption in the kidney. Using dapagliflozin leads to heavy glycosuria (glucose excretion in the urine), which can lead to weight loss and tiredness. Dapagliflozin was approved by the FDA on Jan 08, 2014. Dapagliflozin is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
COA
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 |
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