Bulevirtide Lipopeptide API CAS 2012558-47-1 | Peptide Manufacturer
Bulevirtide Lipopeptide API CAS 2012558-47-1 | Peptide Manufacturer
Bulevirtide API,CAS 2012558-47-1,Bulevirtide lipopeptide,entry inhibitor peptide,Custom Peptide Synthesis,Bulk Peptide Supplier,NTCP receptor antagonist,cGMP Peptide Manufacturing
Source high-purity Bulevirtide lipopeptide API (CAS 2012558-47-1) directly from cGMP manufacturer. Purity ≥98.0% by HPLC. Flexible packaging from mg to bulk kg for antiviral formulation R&D.
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Description
cGMP STANDARD PHARMACEUTICAL PEPTIDE SUPPLIER
Bulevirtide API
CAS No.: 2012558-47-1
Purity (HPLC)≥ 98.0%
Molecular FormulaC248H355N65O72
Molecular Weight5398.95 Da
Peptide Content / AcetateCustom / Controlled
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Scientific Overview & High-Quality Custom Peptide Synthesis
We specialize in the high-end manufacturing and bulk distribution of premium-grade Bulevirtide API (commonly known as Myrcludex B). Synthesized via state-of-the-art automated Solid-Phase Peptide Synthesis (SPPS) platforms coupled with precise N-terminal lipid conjugation, our Bulevirtide raw material features an exceptional purity threshold of ≥ 98.0% (via Reversed-Phase HPLC evaluation). We rigorously monitor single maximum impurities to ≤ 0.5% and control structural peptide deletion fragments to support demanding pharmaceutical development standards.
As a dedicated global supply chain partner, Shaanxi Sunrise Pharmaceutical Co., Ltd. provides comprehensive scalability tailored to your precise timeline. Our operational capacity smoothly spans milligram scale allocations for basic scientific R&D, multi-gram pilot trial batches for advanced formulation exploration, and commercial-scale multi-kilogram bulk quantities. Backed by rigorous quality control architecture, we safeguard the absolute batch-to-batch structural reproducibility required by international chemical buyers.
Pharmacological Profile & API Formulation Targets
Mechanism of Action (MoA) & Receptor Selectivity
Bulevirtide functions as a first-in-class, highly selective hepatotropic entry inhibitor. Biochemically structured as a myristoylated 47-amino acid peptide, it maps precisely to the essential N-terminal domain of the PreS1 envelope section of the Hepatitis B Virus (HBV). This lipopeptide binds with high affinity to the functional receptor NTCP (Sodium Taurocholate Co-transporting Polypeptide) on human hepatocyte membranes. By competitively saturating the NTCP transporter gateway, it prevents HBV and Hepatitis Delta Virus (HDV) from docking onto or entering healthy liver cells, effectively truncating the viral reinfection cascade.
Clinical Formulation Parameters
When successfully integrated into downstream finished subcutaneous injectable configurations, the objective is to optimize targeted therapeutic bioavailability. Finished formulations aim to maintain consistent plasma profiles to significantly diminish circulating HDV viral load and clear serum HDV RNA. This cellular protection fosters the normalisation of serum alanine aminotransferase (ALT) levels, actively mitigating chronic inflammatory progression and downstream hepatic tissue deterioration in adult patients with chronic compensated delta hepatitis.
Pharmaceutical R&D Expansion Pathways
Synergistic Combination Research: Extensively demanded as a core active reference ingredient to evaluate novel co-administration regimes utilizing pegylated interferons and classic nucleos(t)ide analogues.
Fundamental Virology Studies: Serves as a vital analytical probe to dissect the underlying HBV/HDV host-cell penetration kinetics, map receptor interactions, and optimize next-generation entry inhibition pharmacophores.
Technical Specifications & Cold Chain Logistics Standard
| Product Identity | Bulevirtide Acetate (Synthetic Lipopeptide API Raw Powder) |
|---|---|
| Physical Characteristics | White to off-white, amorphous, highly hygroscopic lyophilized cake or powder |
| Purity & Assay (HPLC) | ≥ 98.0% (Reversed-Phase HPLC area normalization) |
| Amino Acid Composition | Conforms exactly to the theoretical 47-amino acid sequence ± 10% |
| Bacterial Endotoxins | ≤ 0.10 EU/mg (Strictly monitored via kinetic LAL method for injection grade evaluation) |
| Moisture Content (Karl Fischer) | ≤ 5.0% |
| Residual Solvents (ICH Q3C) | Meets strict ICH limits for acetonitrile, methanol, and residual cleavage reagents |
| Flexible Packaging Options | • R&D / Pilot Scale: 10 mg, 50 mg, or 100 mg per sterile borosilicate glass vial • Manufacturing Scale: 1 kg to 5 kg per vacuum-sealed multi-layer aluminum foil bag • Bulk Export: 25 kg packed securely within structurally reinforced fiber drums *Custom customized packaging configurations are fully supported upon client requirement. |
| Storage Conditions & Cold Chain | Store tightly sealed and dark at -20°C ± 5°C. Protect diligently from atmospheric humidity and light. Avoid repeated freeze-thaw cycles to prevent oxidation. |
| Shelf Life & Re-test Period | 36 months under optimal sealed conditions in sub-zero freezer inventory. |
Frequently Asked Questions (Peptide Procurement)
Can you guarantee the lipopeptide sequence accuracy and provide batch testing data?
Yes, absolutely. Our Bulevirtide API undergoes precise automated solid-phase peptide synthesis (SPPS) integrated with high-efficiency lipid N-terminal acylation. We provide a comprehensive batch-specific Certificate of Analysis (COA) with every delivery, backed by raw high-resolution Mass Spectrometry (MS) charts for sequence identity validation and detailed analytical HPLC chromatograms confirming a purity threshold of ≥ 98.0%.
Do you accommodate custom packaging sizes for laboratory scale R&D?
Yes, we fully support non-clinical research entities, university laboratories, and formulation chemists. In addition to our commercial multi-kilogram containers, we offer precise milligram-scale down-packaging solutions (spanning 10mg to 100mg) inside sterile, moisture-resistant borosilicate vials to minimize raw material waste during early-stage preclinical validation and assay calibration.
How is the -20°C storage requirement managed during international shipping?
To ensure the absolute biochemical integrity of the lyophilized peptide powder, we implement validated cold-chain logistics for all overseas transit. The product is vacuum-sealed with desiccants inside multi-layer aluminum foil envelopes and packed inside heavy-duty, insulated isothermal shipping containers filled with dry ice or customized cooling gel packs, maintaining sub-zero conditions until final delivery.
Is this API available for direct clinical injection or patient use?
No, it is strictly forbidden. As indicated in our regulatory notice, this material is an active pharmaceutical ingredient and bulk research chemical. It is intended solely for laboratory scientific research and B2B commercial drug synthesis pipelines. It cannot be sold to private individuals, nor can it be deployed directly for human medication, clinical therapies, food additives, or cosmetic applications.
Shaanxi Sunrise Pharmaceutical Co., Ltd.
Senior Independent Site Operations Specialist: Betty
📧 Email: betty@pharma-sunrise.com|💬 WhatsApp: +86 18092760627
Shaanxi Sunrise Pharmaceutical Co., Ltd. | Raw Materials and Ingredients Manufacturer & Supplier | Year 2026