Vaniprevir is a synthetic hepatitis C virus (HCV) NS3/4A protease inhibitor and pharmaceutical active pharmaceutical ingredient (API). It was developed by Merck as MK-7009 and was marketed in Japan under the name Vanihep. Vaniprevir is a macrocyclic antiviral compound designed to inhibit the HCV NS3/4A protease, an enzyme required for processing viral polyproteins and replication of hepatitis C virus.
Vaniprevir is identified by CAS No. 923590-37-8, molecular formula C38H55N5O9S, and molecular weight approximately 757.94 g/mol. PubChem lists the molecular weight as 757.9 g/mol, while the Royal Society of Chemistry's Merck Index record gives 757.94 g/mol.
Vaniprevir is a structurally complex macrocyclic molecule containing multiple stereogenic centers. NCATS identifies five defined stereocenters, making stereochemical identity an important aspect of API characterization.
The principal product information is:
PubChem and NCATS confirm the chemical identity, CAS number, formula, molecular weight and stereochemical characteristics.
Vaniprevir is a non-covalent competitive inhibitor of the HCV NS3/4A protease. This protease is involved in cleavage of the viral polyprotein into proteins required for HCV replication. Inhibition of NS3/4A protease therefore interferes with viral replication.
The compound has been investigated particularly against HCV genotype 1, including genotype 1a and 1b proteases. NCATS describes Vaniprevir as an NS3/4A protease inhibitor with subnanomolar activity against genotype 1a and 1b proteases.
Vaniprevir was developed by Merck and evaluated clinically for chronic hepatitis C. It was launched in Japan as Vanihep, while its broader development program involved investigation in combination with standard antiviral treatment. NCATS currently identifies the substance as possibly marketed outside the United States and records Vanihep as its marketed name.
For pharmaceutical API applications, Vaniprevir is relevant to antiviral research, HCV drug development and pharmaceutical formulation activities involving NS3/4A protease inhibitors.
Vaniprevir is a high-molecular-weight, structurally complex molecule with a calculated XLogP3-AA of approximately 5.1, indicating substantial lipophilic character. PubChem reports an exact mass of 757.37204952 Da.
Commercial research-grade sources describe Vaniprevir as a white to off-white solid. Reported research-product purity values include >98% and 99.60%, but these are individual research-grade product specifications and should not be represented as an official pharmaceutical API release specification.
I could not verify a current USP, Ph. Eur. or JP monograph establishing universal numerical release limits for Vaniprevir API.
Therefore, it would be inappropriate to enter a generic 98.0–102.0% assay, 0.5% LOD, 0.1% residue on ignition, or similar values as though they were official pharmacopoeial limits.
For commercial pharmaceutical material, the exact acceptance criteria should come from the manufacturer's approved specification and applicable regulatory documentation. FDA's ICH Q7A guidance states that each batch of API should undergo appropriate laboratory testing to determine conformance with its specifications and that an impurity profile should be established for each API.
Swapnroop Drugs & Pharmaceuticals can position Vaniprevir as a specialized antiviral API for pharmaceutical development and manufacturing requirements.
As a Vaniprevir API manufacturer and supplier in India, the product can be offered with appropriate control of chemical identity, chromatographic purity, stereochemical identity, residual solvents, water content and other applicable quality attributes according to the approved product specification.
Typical pharmaceutical documentation may include:
Vaniprevir should be stored in appropriate, tightly closed pharmaceutical packaging under conditions established by the approved API specification and stability data.
Research-grade supplier information reports storage at −20°C or 4°C, depending on the storage period and material format. These conditions are research-product recommendations and should not automatically be used as the commercial pharmaceutical API storage specification.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |