- Min.Order :10 Gram
- Purity: 99.9%
- Payment Terms : T/T,Other
Keywords
Entecavir monohydrate Entecavir Entecavir 99.9%
Quick Details
- Appearance:white powder
- Application:209216-23-9 intermediate
- PackAge:fiber can/aluminum foil bag
- ProductionCapacity:2|Kilogram|Month
- Storage:room temperature
- Transportation:by air or by sea
Superiority:
CERTIFICATE OF ANALYSIS of ENTECAVIR MONOHYDRATE
|
Entecavir monohydrate |
|
Product name |
Entecavir monohydrate |
||
|
Inspection Items |
Accepted Standard |
Results |
|
Appearance |
White or almost white powder. |
Complies |
|
solubility |
Practically insoluble in water,in anhydrous ethanol and in heptane,slightly soluble in methanol. |
Complies |
|
Optical rotation |
+24.0°～+28.0° |
+26.8° |
|
Identification |
A:Specific optical rotation |
Complies |
|
B: By IR, To match with working standard |
Complies |
|
|
Water |
5.8%～7.0% |
6.2% |
|
Impurity F |
≤0.1% |
Not found |
|
Related Substances |
Unspecified impurity ≤0.1% |
0.01% |
|
Total impurities ≤0.3% |
0.03% |
|
|
Sulfated ash |
≤0.1% |
0.04% |
|
Heavy |
£10ppm |
Complies |
|
Residual solvents |
Dichloromethane≤600ppm |
Not detected |
|
Methanol≤3000ppm |
Not detected |
|
|
Ethyl acetate≤5000ppm |
200 ppm |
|
|
Toluene≤890ppm |
Not detected |
|
|
Particle size |
95% of the particles should be within 125um |
Complies |
|
Assay |
98.0%～102.0% |
99.9% |
|
Conclusion ：Complies with EP9.0. |
||
Details:
CERTIFICATE OF ANALYSIS
|
Product name |
Entecavir monohydrate |
||
|
Batch No. |
18111201 |
Expiry date |
2021.11 |
|
Report Date |
2018.11.26 |
Quantity |
1200g |
|
Inspection Items |
Accepted Standard |
Results |
|
Appearance |
White or almost white powder. |
Complies |
|
solubility |
Practically insoluble in water,in anhydrous ethanol and in heptane,slightly soluble in methanol. |
Complies |
|
Optical rotation |
+24.0°～+28.0° |
+26.8° |
|
Identification |
A:Specific optical rotation |
Complies |
|
B: By IR, To match with working standard |
Complies |
|
|
Water |
5.8%～7.0% |
6.2% |
|
Impurity F |
≤0.1% |
Not found |
|
Related Substances |
Unspecified impurity ≤0.1% |
0.01% |
|
Total impurities ≤0.3% |
0.03% |
|
|
Sulfated ash |
≤0.1% |
0.04% |
|
Heavy |
£10ppm |
Complies |
|
Residual solvents |
Dichloromethane≤600ppm |
Not detected |
|
Methanol≤3000ppm |
Not detected |
|
|
Ethyl acetate≤5000ppm |
200 ppm |
|
|
Toluene≤890ppm |
Not detected |
|
|
Particle size |
95% of the particles should be within 125um |
Complies |
|
Assay |
98.0%～102.0% |
99.9% |
|
Conclusion ：Complies with EP9.0. |
||
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