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Entecavir monohydrate 2-Amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one monohydrate Entecavir Entecavir 99.9% 209216-23-9
Entecavir hydrate
2-Amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one monohydrate
C12H15N5O3.H2O
295.30
cas: 209216-23-9
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. |
product list is as below:
English Name | CAS NO |
Entecavir monohydrate | 209216-23-9 |
Gadopentetic acid | 80529-93-7 |
Gadopentetate monomeglumine | 92923-57-4 |
Gadopentetate Dimeglumine | 86050-77-3 |
Esomeprazole sodium | 161796-78-7 |
Esomeprazole magnesium (Trihydrate) | 217087-09-7 |
Rebeprazole sodium | 117976-90-6 |
Lansoprazole | 103577-45-3 |
3-Mercaptopropionic acid ( MPA) | 107-96-0 |
Terbinafine HCl | 78628-80-5 |
Butenafine HCl | 101827-46-7 |
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. |
English Name | CAS NO |
Entecavir monohydrate | 209216-23-9 |
Gadopentetic acid | 80529-93-7 |
Gadopentetate monomeglumine | 92923-57-4 |
Gadopentetate Dimeglumine | 86050-77-3 |
Esomeprazole sodium | 161796-78-7 |
Esomeprazole magnesium (Trihydrate) | 217087-09-7 |
Rebeprazole sodium | 117976-90-6 |
Lansoprazole | 103577-45-3 |
3-Mercaptopropionic acid ( MPA) | 107-96-0 |
Terbinafine HCl | 78628-80-5 |
Butenafine HCl | 101827-46-7 |
6-methoxy-2-(4-methoxyphenyl)benzo(b)thiophene | 63675-74-1 |
4-{2-(1-Piperidino)ethoxy}benzoic acid HCl | 84449-80-9 |
Hydroxyethyl Starch130/0.4 | 9005-27-0 |
Hydroxyethyl Starch 200/0.5 | 9005-27-0 |
Sertaconazole nitrate | 99592-39-9 |
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