Telbivudine is a synthetic thymidine nucleoside analogue with antiviral activity against hepatitis B virus (HBV). It belongs to the nucleoside reverse transcriptase inhibitor class and inhibits HBV DNA polymerase, thereby interfering with viral DNA synthesis. FDA chemistry documentation identifies telbivudine as the unmodified β-L enantiomer of naturally occurring thymidine.
Telbivudine has the molecular formula C10H14N2O5 and molecular weight 242.23 g/mol. It is identified by CAS No. 3424-98-4.
Telbivudine is a synthetic antiviral nucleoside analogue developed for the treatment of chronic hepatitis B. It is structurally related to thymidine but contains the β-L configuration, giving it selective antiviral activity against HBV.
The European Medicines Agency classified telbivudine under ATC J05AF11, within the pharmacotherapeutic group of nucleoside and nucleotide reverse transcriptase inhibitors.
FDA documentation confirms the molecular formula, molecular weight, chemical name, three stereocenters and physical appearance.
Telbivudine is an antiviral API used in pharmaceutical formulations for the management of chronic hepatitis B (HBV) infection. EMA documentation describes its indication in adults with chronic hepatitis B and compensated liver disease with evidence of viral replication and active liver inflammation and/or fibrosis.
Telbivudine works by interfering with HBV DNA polymerase activity and inhibiting viral DNA synthesis.
Telbivudine API quality control may include:
Published API specifications report 98.0–102.0% HPLC assay, with additional controls for loss on drying, residue on ignition, impurities and water.
Swapnroop provides quality-focused pharmaceutical API solutions supported by analytical testing, technical documentation and customer-specific specifications.
Telbivudine API can be supported with appropriate CoA, specification and technical documentation according to the intended pharmaceutical application.
Telbivudine should be stored in suitable, well-closed pharmaceutical packaging that protects the API from excessive moisture, contamination and unsuitable environmental conditions.
The specific storage conditions should follow the applicable approved specification and stability data for the supplied batch.
Typical documentation may include:
Swapnroop focuses on quality-oriented pharmaceutical API solutions with analytical testing and technical documentation. Telbivudine can be supplied according to agreed specifications and customer requirements for pharmaceutical development and manufacturing.
| 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 0.2% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 1.0% |