Entecavir Hydrate factory Entecavir Hydrate supplier Entecavir Hydrate seller
We have two GMP facilities in Hubei Province and cooperative factories in Zhejiang Province
We are concentrating on the R&D and technical service of APIs and pharmaceutical intermediates
Year Establishment: 2009
Location: 18-1-802, Green Garden, Jianghan District, Wuhan 430023, China
Main Products: API of antineoplastic & Cardiovascular drugs ; Antibiotic products
Specifications: Entecavir Hydrate (CAS:209216-23-9)
ITEMS |
SPECIFICATIONS |
RESULTS |
|
Description |
Off-white to white powder |
White powder |
|
Solubility |
Soluble in DMF, slightly soluble in water and in ethanol (99.5%) and in methanol |
Conforms |
|
pH |
5.5 ~ 7.5 ( 100mg in 10ml water) |
6.2 |
|
Identification
|
1) IR absorption spectrum of the sample must be concordant with entecavir |
Conforms |
|
2)RT of the sample should match that of standard in assay preparation |
Conforms |
||
Specific Rotation |
+24°~+28°(C=1 CH3OH/DMF=1:1 |
+ 26.3° |
|
Water |
5.8 % ~ 6.5 % |
6.25% |
|
Enantiomer |
≤0.1 % |
ND |
|
Single impurities |
≤0.1 % |
0.07% |
|
Total impurities |
≤0.3% |
0.15% |
|
Heavy metals |
≤10ppm |
<10ppm |
|
Residue on Ignition |
≤0.1% |
0.04% |
|
Residual solvents |
MeOH |
≤600ppm |
Conforms |
CH2Cl2 |
≤300ppm |
||
THF |
≤720ppm |
||
DMF |
≤880ppm |
||
Ethylacetate |
≤5000ppm |
||
Toluene |
≤890ppm |
||
CH2Br2 CH2Cl2 |
≤600ppm |
||
Tert-butyl alcoho |
≤5000ppm |
||
Total |
≤1000ppm |
||
Purity by HPLC |
98.0%~102.0% |
99.85% |
|
Conclusion: |
The results conform to the in-house standard. |
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