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Entecavir monohydrate Entecavir Entecavir 99.9%
Entecavir monohydrate,Entecavir monohydrate,Entecavir monohydrate,Entecavir monohydrate,Entecavir monohydrate.
Entecavir monohydrate,Entecavir monohydrate,Entecavir monohydrate,Entecavir monohydrate,Entecavir monohydrate.
CERTIFICATE OF ANALYSIS
Product name |
Entecavir monohydrate |
Inspection Items |
Accepted Standard |
Results |
Appearance |
White to off-white powder |
Complies |
Optical rotation |
+24.0°—+30.0°(DMF:MeOH=1:1 c=1%) |
+26.9° |
Identification |
A: By IR, To match with working standard |
Complies |
B:By HPLC,retain time should match with working standard |
Complies |
|
Water |
5.5%—7.0% |
6.2% |
Related Substances |
Furoentecavira ≤0.1% |
Not found |
Entecavir 1-epimerb. ≤0.1% |
Not found |
|
Entecavir 3-epimerc ≤0.1% |
Not found |
|
8-Hydroxy entecavird ≤0.1% |
Not found |
|
Entecavir 4-epimere ≤0.1% |
Not found |
|
8-Methoxy entecavirf ≤0.1% |
Not found |
|
4-Dimethylsily entecavirg. ≤0.1% |
Not found |
|
Entecavir related compound A ≤0.1% |
Not found |
|
Any unspecified impurity ≤0.1% |
0.01% |
|
Total impurities ≤0.3% |
0.03% |
|
Residue on ignition |
≤0.1% |
0.04% |
Heavy metals |
£ 10ppm |
Complies |
Residual solvents |
Should complies |
Complies |
Assay |
98.0-102.0% |
99.8% |
Conclusion :Complies to USP39. |
Entecavir monohydrate,Entecavir monohydrate,Entecavir monohydrate,Entecavir monohydrate,Entecavir monohydrate。
Entecavir monohydrate,Entecavir monohydrate,Entecavir monohydrate,Entecavir monohydrate,Entecavir monohydrate。
CERTIFICATE OF ANALYSIS
Product name |
Entecavir monohydrate |
Inspection Items |
Accepted Standard |
Results |
Appearance |
White to off-white powder |
Complies |
Optical rotation |
+24.0°—+30.0°(DMF:MeOH=1:1 c=1%) |
+26.9° |
Identification |
A: By IR, To match with working standard |
Complies |
B:By HPLC,retain time should match with working standard |
Complies |
|
Water |
5.5%—7.0% |
6.2% |
Furoentecavira ≤0.1% |
Not found |
|
Entecavir 1-epimerb. ≤0.1% |
Not found |
|
Entecavir 3-epimerc ≤0.1% |
Not found |
|
8-Hydroxy entecavird ≤0.1% |
Not found |
|
Entecavir 4-epimere ≤0.1% |
Not found |
|
8-Methoxy entecavirf ≤0.1% |
Not found |
|
4-Dimethylsily entecavirg. ≤0.1% |
Not found |
|
Entecavir related compound A ≤0.1% |
Not found |
|
Any unspecified impurity ≤0.1% |
0.01% |
|
Total impurities ≤0.3% |
0.03% |
|
Residue on ignition |
≤0.1% |
0.04% |
Heavy metals |
£ 10ppm |
Complies |
Residual solvents |
Should complies |
Complies |
Assay |
98.0-102.0% |
99.8% |
Conclusion :Complies to USP39. |
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