Bulevirtide Powder Cas No.2012558-47-1
Specification: ≥99%
CAS No.: 2012558-47-1
Analytical Method: HPLC
Active Ingredient: Bulevirtide
Product Characteristics: White to off-white hygroscopic solid powder
Packaging: Available in various specifications (mg, g, kg), custom packaging is available
Storage Condition: Store in a cool, dry place at -20°C, protected from light
Shelf Life: 36 months
Declaration of Use: This product is intended for industrial use or scientific research only.
Bulevirtide API Powder | CAS 2012558-47-1 | HBV/HDV Entry Inhibitor
Bulevirtide (formerly Myrcludex B) is a highly complex, first-in-class synthetic lipopeptide comprising 47 amino acids with a critical N-terminal myristoylation. Xi'an Tihealth Biotechnology Co., Ltd. leverages advanced solid-phase peptide synthesis (SPPS) and targeted lipidation technologies to produce this active pharmaceutical ingredient (API) with an uncompromising HPLC purity of ≥ 99.0%. Functioning as a potent viral entry inhibitor targeting the NTCP receptor, our Bulevirtide API is the foundational raw material for developing breakthrough therapeutics against chronic Hepatitis D (HDV) and Hepatitis B (HBV) co-infections.
⚠️ REGULATORY COMPLIANCE & STRICT RESEARCH USE ONLY (RUO)
Industrial R&D Application: This high-purity Bulevirtide lipopeptide is supplied strictly as a bulk API powder for professional laboratory research, biopharmaceutical formulation scale-up, and preclinical virology assays. It is NOT a finished pharmaceutical drug product and is explicitly prohibited for direct administration to humans.
Chemical Profile & Specification Parameters
| Analytical Parameter | Xi'an Tihealth Specification |
|---|---|
| Generic Name | Bulevirtide (Myristoylated PreS1 Lipopeptide) |
| CAS Number | 2012558-47-1 |
| Molecular Formula | C216H340N68O68S4 |
| Molecular Weight | 4725.3 g/mol |
| Peptide Purity (HPLC) | ≥ 99.0% (Strict monitoring of des-myristoyl impurities) |
| Appearance | White to off-white lyophilized powder |
Storage & Formulation Protocols: Store strictly at -20°C in a desiccated environment. Due to the hydrophobic myristoyl lipid chain, this API exhibits unique amphiphilic properties. Formulators must employ appropriate excipients during the lyophilization process to prevent micelle aggregation and ensure rapid reconstitution.
Viral Entry Inhibition Mechanism (NTCP Targeting)
Bulevirtide operates through a highly specific and potent mechanism, cutting off the viral life cycle at the very first step of hepatocyte infection:
- NTCP Receptor Blockade: The peptide mimics the N-terminal preS1 domain of the HBV large envelope protein. It binds with extremely high affinity to the Sodium/Taurocholate Cotransporting Polypeptide (NTCP), the essential entry receptor located on the basolateral membrane of hepatocytes.
- Myristoylation-Dependent Anchoring: The covalently attached N-terminal myristoyl group is not merely structural; it acts as a lipid anchor, inserting into the hepatocyte membrane to facilitate irreversible competitive inhibition against circulating virions.
- Synergistic Viral Clearance: By preventing de novo infection of healthy hepatocytes, Bulevirtide isolates the virus, leading to a profound reduction in HDV RNA levels and allowing the host's immune system or adjunctive therapies to clear infected cells.
Therapeutic R&D & Virology Applications
Xi'an Tihealth supplies this challenging lipopeptide API to empower pharmaceutical developers tackling the most severe forms of chronic viral hepatitis:
- Chronic HDV Therapeutics: Used as the core active ingredient in the development of daily subcutaneous lyophilized powder injections aimed at treating compensated chronic Hepatitis D virus infections.
- Combination Regimen Research: A critical API for exploring synergistic therapeutic strategies, commonly investigated alongside Pegylated Interferon Alpha (Peg-IFNα) or Nucleos(t)ide analogues (NUCs) to achieve functional cures.
- Hepatology Research Tools: Widely utilized by virology labs as a gold-standard NTCP inhibitor to study bile acid transport, host-pathogen interactions, and the molecular dynamics of HBV/HDV entry.
API Procurement & Technical FAQ
Attaching a fatty acid chain to a 47-amino-acid peptide requires highly optimized synthetic coupling protocols to avoid incomplete lipidation. Every batch undergoes rigorous Electrospray Ionization Mass Spectrometry (ESI-MS) to verify the exact molecular mass (4725.3 Da), guaranteeing 100% successful myristoylation and the absence of des-myristoyl impurities.
Yes. Because Bulevirtide is exclusively developed as a subcutaneous injection, we maintain stringent bioburden and endotoxin monitoring (LAL testing < 0.5 EU/mg) to ensure our API seamlessly supports your aseptic formulation development and downstream clinical safety requirements.
We supply a robust analytical data package designed to support global regulatory filings. This includes the Certificate of Analysis (COA), high-resolution HPLC chromatograms, MS sequence mapping, and comprehensive reports on residual solvents (ICH Q3C) and heavy metals.
Xi'an Tihealth Biotechnology Co., Ltd. Quality Commitment: GMP-aligned pharmaceutical API intended strictly for laboratory analysis and formulation R&D. Not for direct clinical administration.
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