2-Amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one Factory、Manufacturers、Raw material 、Low price Assay99%、CP、EP、USP、JP、BP、GMP
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CERTIFICATE OF ANALYSIS
Product Name |
ENTECAVIR MONOHYDRATE (IN-HOUSE Standard) |
||
Production Date |
2013.08.03 |
||
Expire Date |
2015.08.02 |
||
Batch Number |
BJZSETV130803 |
||
Net Weight |
10.0g |
||
CAS number |
209216-23-9 |
||
Structure |
|
||
Items |
Specifications |
Results |
|
Appearance |
White or off-white crystalline powder |
Complies |
|
Partical Size |
90% NMT30UM |
Complies |
|
Identification |
H-1 NMR spectrum |
Complies |
|
Specific Rotation |
〔α〕22D=+24~28° |
+26.8° |
|
Melting Point |
≥230℃ |
Complies |
|
Water |
5.0%-7.0% |
6.2% |
|
Residue on ignition |
≤0.1% |
0.06% |
|
Assay |
≥99.7% |
99.9% |
|
Single Impurity |
≤0.10% |
0.01% |
|
Total Impurities |
≤0.10% |
0.02% |
|
Residual solvents |
MeOH≤600ppm |
200ppm |
|
CH2CL2≤300ppm |
0ppm |
||
Total≤1000ppm |
conform |
||
Conclusion |
|
Passed |
Identification | ||
Name | Entecavir hydrate | |
Synonyms | 2-Amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one monohydrate | |
Molecular Structure | ||
Molecular Formula | C12H15N5O3.H2O | |
Molecular Weight | 295.30 | |
CAS Registry Number | 209216-23-9 |
CAS NO:73-78-9
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