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Name |
Dapagliflozin |
Alias |
Bms 512148; BMS5121458; DAPAGLIFLOZIN;B MS-512148-05; Dag coluMn net; Dapagliflozin, >=98%; Dapagliflozin(BMS-512148); Dapagliflozin propanediol; Dapagliflozin Isomer Impurity; Dapagliflozin S1548 Selleck |
CAS NO. |
461432-26-8 |
Molecular Formula |
C21H25ClO6 |
Molecular Weight |
408.8726 |
Grade Standard |
Medicine grade / 99% min / GMP application / PMDA / DMF |
Package Size |
25kg/drum |
Storage: |
Keep in a well-closed container, protected from light and stored at a temperature of 2 to 8 |
ITEMS |
STANDARDS |
RESULTS |
Appearance |
White powder |
Complies |
Identification |
HPLC/NMR |
Complies |
Purity |
Not less than 99.5% |
99.85% |
Assay |
98.0-102.0% |
99.2% |
Individual impurity |
Not more than 0.1% |
0.04% |
Total impurity |
≤0.5% |
0.15 |
Particle size distribution |
D90<75μm |
Complies |
Residue on ignition |
≤0.1% |
Complies |
Heavy metals |
≤20ppm |
Complies |
Melting point |
71-78℃ |
73.2-74.5℃ |
Isomer |
≤0.15% |
N/A |
Percentage of Propanediol |
13.6%~16.6% |
14.3% |
Water |
3.0%-4.4% |
3.8% |
Loss on drying |
≤1.0% |
Complies |
Optical rotation |
+13° to +17° |
Complies |
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