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1 Kilogram |
Negotiable |
Entecavir Entecavir 99% Entecavir API
99%min
Entecavir
【Appearance】 |
A white to nearly white crystalline powder, odorless. |
Solubility |
Very slightly soluble in water, slightly soluble in methanol, practically insoluble in aether. |
Specific rotation |
+24°~ +28° |
【Identification】 |
|
(1) |
The retention time of the principle peak obtained from the test solution is identical with that obtained from reference solution. |
(2) |
The infrared absorption spectrum is identical with that of reference. |
【Inspection】 |
|
PH |
5.5~7.5 |
Related substances |
|
(1) |
Single largest unknown≤0.10% |
(2) |
Total impurities≤0.30% |
Enantiomers |
≤0.2% |
Methanol |
≤0.3% |
Dichloromethane |
≤0.06% |
n-Hexane |
≤0.029% |
Tetrahydrofuran |
≤0.072% |
N,N-dimethylformamide |
≤0.088% |
Toluene |
≤0.089% |
Water |
5.8%~6.5% |
Residual on ignition |
≤0.1% |
Heavy metal |
≤20ppm |
【Assay 】 |
98.0%~102.0%(C12H15N5O3, on anhydrous basis) |
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