Dapagliflozin is a prescription medication that is mainly used alongside diet and exercise to help treat type 2 diabetes, but it is also used in the treatment of heart failure. It was first approved by the US Food and Drug Administration (FDA) in 2014.Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. This class of drug uses the kidneys to help control your glucose (blood sugar) levels. It works by increasing the amount of glucose removed from the body when you urinate. It also reduces the amount of effort your heart has to put in to pumping blood around your body.
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Items | Standards | Results |
Aspectus | White or off-white crystalline powder | Obsequitur |
Identification | By IR | Obsequitur |
By HPLC | Obsequitur | |
Solubility | Highly soluble in methanol,soluble in ethanol,acetonitrile; slightly soluble in water |
Obsequitur |
Water Content | 3.00%~4.40% | 3.60% |
Liquefactio Point | 69~75ºC | 73.4~74.7ºC |
Heavy Metal | ≤20ppm | Obsequitur |
Isomer | ≤0.15% | 0.03% |
Propylene Glycol Content | 13.6%~16.6% | 15.3% |
Residual Solvents | Ethanol: ≤1000ppm | ND |
Ethyl acetate: ≤1000ppm | ND | |
Dichloromethane: ≤120ppm | ND | |
Hexane: ≤600ppm | 68ppm | |
Related Substances | Any Single Impurities: ≤0.10% | 0.05% |
Total Impurities: ≤0.50% | 0.12% | |
Purity(HPLC) | ≥99.50% | 99.88% |
Assay (HPLC basis on drying) |
98.0%~102.0% | 99.96% |
Particle Size | D90: ≤50µm, D98: ≤80µm | 30µm, 38µm |
Reference Standard | In-house Standard | |
conclusio | The product complied to In-house standard. |
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