PRODUCT DISPLAY
CONTANT US
China Entecavir API Supplier,China Entecavir ManufacturerHits:4454
Time:2019-03-08 17:13:12 |
Items | Specifications | Results |
Appearance | White to off-white crystalline powder | Complies |
Optical rotation | +24.0°—+28.0°(DMF:MeOH=1:1 c=1%) | +26.8° |
Identification | A: IR, spectrum of sample complies with that of standard sample |
Complies |
B: HPLC, retention time of sample complieswith that of standard sample |
Complies | |
Water | 5.8%—6.5% | 6.1% |
Related Substances | Single impurity ≤0.1% | 0.02% |
Total impurities ≤0.3% | 0.03% | |
Granularity | Particle size D50≤6.0μm D90≤12.5μm |
Complies |
Residue on ignition | ≤0.1% | 0.06% |
Heavy metals | ≤20ppm | Complies |
Residual solvents | Match with the standard of USP32 | Complies |
Assay | ≥99.5% | 99.8% |
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