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Active Pharmaceutical Ingredient 99% purity Enticavir /CAS
142217-69-4
Specifications:
Name:Enticavir
Synonyms : 2-Amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one
Molecular Formula : C12H15N5O3
Molecular Weight : 277.28
CAS:142217-69-4
Uses:
Entecavir is an oral antiviral drug used in the treatment of hepatitis B infection. Entecavir is a nucleoside analog (more specifically, aguanosineanalogue) that inhibits reverse transcription, DNA replication and transcription in the viral replication process. The drug's manufacturer claims that entecavir is more efficacious than previous agents used to treat hepatitis B (lamivudine and adefovir). It also helps prevent the hepatitis B virus from multiplying and infecting new liver cells. Entecavir is also indicated for the treatment of chronic hepatitis B in adults with HIV/AIDS infection.
Certificate of Analysis
Items | Specifications |
[Description ] | It should be white or whitish crystalline powder, odorless and tasteless, very slightly in water, slightly soluble in methanol and insoluble in ether. |
Specific rotation | Should be between +24°~+28° |
[Identification] | |
(1) HPLC | Retention time of the principal peak obtained from the test solution should be identical with that of the reference solution. |
(2) IR | IR spectrum of samples should be identical with that of the reference standard. |
[Test] | |
pH | Should be between 5.5~7.5 |
Related substances | |
(1)Total impurity | Should be 0.3%max |
(2)maximum single impurity | Should be 0.1%max |
Enantiomer | Should be 0.2%max |
Methanol | Should be 0.3%max |
Dichloromethane | Should be 0.06%max |
N- hexane | Should be 0.029%max |
Tetrahydrofuran | Should be 0.072%max |
N,N-dimethylformamide | Should be 0.088%max |
Toluene | Should be 0.089%max |
Water | Should be between 5.8%~6.5% |
Residue on ignition | Should be 0.1%max |
Heavy metal | Should be 20ppmmax |
Assay | 98.0%~102.0%(C12H15N5O3) calculated on anhydrous basis |
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Active Pharmaceutical Ingredient 99% purity Entecavir /CAS 142217-69-4 Images |