Entecavir is a synthetic nucleoside analogue antiviral agent used primarily for the treatment of chronic hepatitis B virus (HBV) infection. It is a guanosine nucleoside analogue that inhibits the HBV polymerase/reverse transcriptase, interfering with viral DNA synthesis.
Entecavir is a potent and selective antiviral pharmaceutical ingredient belonging to the cyclopentyl guanosine analogue class.
Entecavir is an orally active antiviral drug used for the management of chronic hepatitis B infection. It inhibits several activities of the HBV polymerase, including initiation, reverse transcription and synthesis of the positive DNA strand.
Entecavir has the molecular formula C₁₂H₁₅N₅O₃ and a molecular weight of approximately 277.28 g/mol.
Swapnroop Drugs and Pharmaceuticals provides Entecavir API for qualified pharmaceutical manufacturing, formulation development, research and pharmaceutical sourcing requirements.
Entecavir is a specialized antiviral API used in pharmaceutical formulations for chronic hepatitis B therapy.
Entecavir is phosphorylated intracellularly to its active triphosphate form. Entecavir triphosphate competes with the natural deoxyguanosine triphosphate substrate and inhibits the HBV polymerase.
It inhibits:
This suppresses HBV DNA replication.
Entecavir is associated with:
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |