Swapnroop Drugs & Pharmaceuticals offers Bulevirtide for pharmaceutical research, formulation development and commercial supply requirements. Bulevirtide is a modified lipopeptide antiviral that inhibits hepatitis B and hepatitis D virus entry into hepatocytes by targeting the sodium taurocholate co-transporting polypeptide (NTCP).
Bulevirtide is the active substance of Hepcludex and is supplied as bulevirtide acetate. The European Medicines Agency identifies Bulevirtide as a 47-amino-acid peptide containing an N-terminal myristoyl residue and a C-terminal amide. The active substance is available as an acetate salt.
Bulevirtide has the molecular formula C248H355N65O72 and a relative molecular mass of approximately 5398.9 g/mol. PubChem reports a molecular weight of approximately 5399 g/mol. The CAS number is 2012558-47-1.
Bulevirtide is classified as a direct-acting antiviral and is listed under ATC code J05AX28. It is indicated for chronic hepatitis delta virus (HDV) infection in appropriate patients with compensated liver disease.
Product Name: Bulevirtide
Salt Form: Bulevirtide Acetate
CAS Number: 2012558-47-1
Molecular Formula: C248H355N65O72
Molecular Weight: Approximately 5398.9 g/mol
Chemical Class: Modified lipopeptide
Therapeutic Category: Antiviral
ATC Code: J05AX28
Biological Target: NTCP
Bulevirtide is an antiviral entry inhibitor used in the treatment of chronic hepatitis D virus infection. It blocks the NTCP receptor involved in the entry of hepatitis B and hepatitis D viruses into hepatocytes.
Bulevirtide is described as a white to off-white hygroscopic powder or lyophilized material. The marketed pharmaceutical product is supplied as a sterile, preservative-free white to off-white lyophilized powder for solution for injection.
The active substance is supplied as an acetate salt. The acetate counter-ion is present in a non-stoichiometric ratio.
Appearance: White to off-white lyophilized powder / hygroscopic powder
Identification: HPLC and LC-MS/MS / peptide identity testing
Assay (HPLC): ≥98.0% peptide purity is reported by a commercial API supplier; final commercial specification should follow the applicable batch COA.
Loss on Drying: Moisture content ≤5.0% is reported for a commercial Bulevirtide acetate API specification.
Residue on Ignition: Not a suitable universal specification for this peptide API; use the applicable manufacturer specification.
Heavy Metals: Applicable limits should follow the applicable pharmaceutical elemental-impurity specification.
pH (1% Solution): The reconstituted marketed product has a pH of approximately 9.0. This is a finished-product/reconstituted solution value, not necessarily a 1% API solution specification.
Individual Impurity: Product-specific peptide-related impurity limits should be controlled according to the applicable API specification.
Total Impurities: Product-specific peptide-related impurity limits should be controlled according to the applicable API specification.
Water Content: ≤5.0% is reported for a commercial Bulevirtide acetate API specification.
Specific Rotation: Not routinely used as the primary release specification for this peptide API.
Melting Point: Not applicable as a useful specification for this large peptide/lipopeptide API.
Solubility: Practically insoluble in water; reported soluble in 50% acetic acid and in carbonate buffer around pH 8.8.
The European product Hepcludex contains bulevirtide acetate equivalent to 2 mg bulevirtide per vial. The powder is white to off-white and is reconstituted before subcutaneous administration. After reconstitution, the solution has a pH of approximately 9.0.
The current U.S. product information also describes Hepcludex as a sterile, preservative-free white to off-white lyophilized powder or cake for subcutaneous injection.
Packaging may be provided according to customer requirements, product grade, quantity and applicable pharmaceutical handling requirements. Bulevirtide products require appropriate storage and handling because the material is a peptide/lipopeptide and is hygroscopic.
Applicable documentation may include Certificate of Analysis (CoA), product specification, safety documentation and other quality documents according to product grade and customer requirements.
Store Bulevirtide according to the applicable product specification and stability data. For finished pharmaceutical products, follow the approved storage conditions specified in the applicable regulatory product information.
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical customers with API sourcing and supply requirements. Contact Swapnroop Drugs & Pharmaceuticals for Bulevirtide availability, product specifications, documentation, packaging and commercial supply information.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | HPLC / LC-MS/MS peptide identity |
| Assay (HPLC) | ≥98.0% peptide purity |
| Loss on Drying | ≤5.0%* |
| Water Content | ≤5.0%* |