Name Entecavir hydrate
C12H15N5O3.H2O
295.30
CAS :209216-23-9
Detailed introduction to Entecavir hydrate cas209216-23-9:
|
Inspection Items |
Accepted Standard |
Results |
|
Appearance |
White to off-white powder |
Complies |
|
Optical rotation |
+24.0°_+28.0°(DMF:MeOH=1:1 c=1%) |
+26.1° |
|
Identification |
A: By IR, To match with working standard |
Complies |
|
B:By HPLC,retain time should match with working standard |
Complies |
|
|
Water |
5.8%_6.5% |
6.22% |
|
Isomer |
Single ≤0.1% |
0.09% |
|
Total ≤0.5% |
0.1% |
|
|
Related Substances |
Single impurity ≤0.1% |
0.08% |
|
Total impurities ≤0.3% |
0.10% |
|
|
Residue on ignition |
≤0.1% |
Complies |
|
Heavy metals |
£ 20ppm |
Complies |
|
Residual solvents |
Should be to match with the standard |
Complies |
|
Assay |
≥99.5% |
99.8% |
|
Conclusion :Complies to the enterprise standard |
||
|
Inspection Items |
Accepted Standard |
Results |
|
Appearance |
White to off-white powder |
Complies |
|
Optical rotation |
+24.0°_+28.0°(DMF:MeOH=1:1 c=1%) |
+26.1° |
|
Identification |
A: By IR, To match with working standard |
Complies |
|
B:By HPLC,retain time should match with working standard |
Complies |
|
|
Water |
5.8%_6.5% |
6.22% |
|
Isomer |
Single ≤0.1% |
0.09% |
|
Total ≤0.5% |
0.1% |
|
|
Related Substances |
Single impurity ≤0.1% |
0.08% |
|
Total impurities ≤0.3% |
0.10% |
|
|
Residue on ignition |
≤0.1% |
Complies |
|
Heavy metals |
£ 20ppm |
Complies |
|
Residual solvents |
Should be to match with the standard |
Complies |
|
Assay |
≥99.5% |
99.8% |
|
Conclusion :Complies to the enterprise standard |
||