1. The IR absorption spectrum of the sample must be concordant with entecavir
2. RT of the sample should match that of standard in assay preparation
Conforms
Conforms
Particle size
95% of the particles should be within 125um
Conforms
Optical rotation
+24°～+28°(DMF:MOH=1:1c=1%)
+26.2°
Water
5.8%～6.5%
6.1%
Residue on ignition
≤0.1%
0.07%
Heavy metals
≤20ppm
＜20ppm
Related substances
Total impurities≤0.3%
Single impurity≤0.1%
0.04
0.01%
Assay
99.0%～101.0%
99%
Residual solvents
MeOH≤600ppm
CH2Cl2≤300PPM
Total≤1000ppm
200ppm
0ppm
Conforms
Conclusion
It conforms to the enterprise standard.
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