Voxilaprevir is a direct-acting antiviral (DAA) medication used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV). As a noncovalent, reversible inhibitor of HCV NS3/4A protease, Voxilaprevir demonstrates potent in vitro antiviral activity against genotypes 1–6 HCV with broad coverage of NS3/4A protease polymorphisms. Voxilaprevir inhibits genotype 1b and 3a wild-type NS3 proteases with Ki values of 0.038 nM and 0.066 nM, respectively. Since July 2017, Voxilaprevir has been available in a fixed-dose combination product with sofosbuvir and velpatasvir as Vosevi®, approved for adult patients with chronic HCV infection with genotypes 1–6. Notably, Voxilaprevir is approved for use in patients who have been previously treated with an NS5A inhibitor—a patient population for which no approved retreatment options existed prior to Vosevi.
Product Parameters
|
Parameter |
Specification |
|
Product Name |
Voxilaprevir |
|
CAS Number |
1535212-07-7 |
|
Molecular Formula |
|
|
Molecular Weight |
|
|
Appearance |
White solid |
|
Density |
1.42±0.1 g/cm3 |
|
Storage Condition |
−20 °C |
Why Cosperpharm?
Potency begins with purity. Voxilaprevir inhibits HCV NS3/4A protease with Ki values as low as 0.038 nM—a level of potency that demands strict impurity control. Any process-related impurity in this macrocyclic API can compromise antiviral activity against the full range of HCV genotypes. Our analytical release protocol for Voxilaprevir includes HPLC purity verification (≥98%), residual solvent analysis, and identity confirmation—because your therapeutic outcomes depend on the quality of this advanced antiviral.
Documentation that supports regulatory submission. As a key component of Vosevi®, Voxilaprevir reference standards are essential for ANDA filings. Every shipment includes a Certificate of Analysis (COA) with batch-specific purity and characterization data—structured for direct insertion into your method validation package. DMF-ready documentation and custom quality agreements are available upon request.
Flexible supply across all development stages. Cosperpharm supplies Voxilaprevir across the full range of applications—from 100 mg–1 g reference standard quantities for analytical method development and QC testing, to 5 g–50 g batches for process validation, to kilogram-scale quantities for commercial manufacturing. R&D samples ship within 5–7 business days; bulk orders ship within 2–3 weeks.
Technical support for the full synthetic cascade. Our process chemistry team can advise on macrocyclic scaffold synthesis, impurity profiling strategies, and analytical methods for detecting process-related impurities—because we have worked extensively with this complex fluorinated macrocycle across multiple manufacturing campaigns.
Global reach with transparent pricing. Cosperpharm ships to pharmaceutical manufacturers, CROs, and analytical laboratories worldwide, with full customs documentation included. Volume discounts apply at larger scales, and we communicate lead times upfront.
Storage Conditions
Shelf life: 3 years when stored at −20 °C in a sealed, dry container under inert atmosphere; 2 years when stored at 4 °C. In solution, store at −80 °C for 6 months or −20 °C for 1 month. Avoid repeated freeze-thaw cycles.
Handling precautions: Use only in a fume hood. Wear chemical-resistant gloves (tested against EN 374 or equivalent), safety goggles, and a lab coat. Avoid generating dust or aerosols. Do not eat, drink or smoke in work areas. After handling, wash hands thoroughly. Refer to the Safety Data Sheet (SDS) for complete safety information.
Product Quality Assurance
Thorough analytical characterization. Each batch undergoes multi-technique analytical release testing: HPLC purity (≥98%), appearance verification, water content determination (Karl Fischer), residual solvent analysis (GC), and where applicable, ¹H NMR and MS confirmation of molecular identity.
Full batch traceability with retention samples. From raw material procurement through synthesis, purification, drying, and final packaging, every step is fully documented and traceable. Each batch receives a unique lot number with sufficient retention samples maintained in accordance with Cosperpharm quality procedures.
Stability monitoring program. Cosperpharm conducts ongoing stability studies under recommended storage conditions: long-term storage at −20 °C under inert atmosphere, with accelerated stability studies conducted on representative batches. Stability summaries are updated regularly, with full data packages available to support customer regulatory submissions. Shelf life: 3 years at −20 °C; 2 years at 4 °C.
Documentation ready for regulatory submission. Every shipment includes a Certificate of Analysis (COA) with batch-specific purity and characterization data, a Material Safety Data Sheet (SDS), and customs documentation for international delivery. For customers preparing ANDA or NDA filings, Cosperpharm provides DMF-ready documentation packages, method validation reports, stability data, and custom quality agreements upon request.
Customer-initiated quality audits. Qualified customers are welcome to audit Cosperpharm's manufacturing, quality control, and documentation facilities. Please contact our regulatory team to schedule an audit.
Contact Us
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No. 2 Yangguang 3rd Road, Duodao Chemical Cycle Industrial Park, Jingmen City, Hubei Province, China
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