Narlaprevir API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Narlaprevir API

Narlaprevir is a synthetic hepatitis C virus (HCV) NS3/4A serine protease inhibitor developed as a direct-acting antiviral compound. It is also known by the development code SCH 900518.

Narlaprevir targets the HCV NS3/4A protease, an enzyme required for processing the viral polyprotein into functional proteins necessary for viral replication. By inhibiting this protease, Narlaprevir interferes with the HCV replication cycle.

Narlaprevir has the molecular formula C36H61N5O7S, CAS Number 865466-24-6, and molecular weight approximately 707.97 g/mol. These chemical identity values are supported by PubChem and ChEMBL.

Narlaprevir API Manufacturer in India

Narlaprevir is a well-characterized antiviral pharmaceutical API associated with direct-acting antiviral research and HCV NS3/4A protease inhibition.

Important API quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities and other applicable pharmaceutical quality parameters.

Narlaprevir is also identified as SCH 900518 / SCH-900518 in pharmaceutical and scientific literature.

Chemical Information

CAS Number: 865466-24-6

Molecular Formula: C36H61N5O7S

Molecular Weight: 707.97 g/mol

Chemical Name: Narlaprevir

Development Code: SCH 900518

Drug Class: HCV NS3/4A Protease Inhibitor

Therapeutic Class: Direct-Acting Antiviral

Therapeutic Area: Infectious Diseases / Hepatology

Molecule Type: Synthetic Small Molecule

Mechanism of Action

Narlaprevir is a reversible inhibitor of the HCV NS3/4A serine protease. The NS3/4A protease is essential for cleavage and processing of the HCV polyprotein.

Its antiviral mechanism includes:

  • Inhibition of HCV NS3/4A serine protease
  • Interference with viral polyprotein processing
  • Disruption of production of functional viral proteins
  • Inhibition of HCV replication
  • Direct-acting antiviral activity against HCV
  • Targeted inhibition of viral protease activity

The International Union of Basic and Clinical Pharmacology describes narlaprevir as an oral HCV NS3 serine protease inhibitor.

Pharmaceutical Applications

Narlaprevir API is relevant to:

  • HCV antiviral drug development
  • NS3/4A protease inhibitor research
  • Direct-acting antiviral research
  • Hepatitis C pharmaceutical development
  • Antiviral formulation development
  • Pharmaceutical API manufacturing
  • HCV resistance research
  • Viral protease research
  • Pharmaceutical research and development
  • Analytical and quality-control testing

Hepatitis C Applications

Narlaprevir was developed as a direct-acting antiviral for chronic hepatitis C virus infection, particularly targeting HCV NS3/4A protease.

Clinical development and pharmacological studies investigated Narlaprevir in HCV treatment, including its use with other antiviral agents. Its regulatory and clinical status should be described according to the relevant country and current regulatory framework rather than implying universal approval.

HCV NS3/4A Protease

The HCV NS3/4A protease is an essential viral enzyme involved in processing the HCV polyprotein.

Narlaprevir binds to the protease and inhibits its enzymatic activity. This prevents proper processing of viral proteins required for productive viral replication.

Research has also investigated the molecular basis of resistance to Narlaprevir-associated NS3 mutations.

Physical Characteristics

Narlaprevir is generally described as a white to off-white solid/powder in chemical supplier and research-product information.

Its physical properties, crystalline characteristics, particle size and other material attributes should be controlled according to the applicable pharmaceutical/API specification.

Manufacturing Process

A controlled Narlaprevir API manufacturing process may involve:

  1. Qualification of starting materials
  2. Preparation of protected amino-acid and bicyclic intermediates
  3. Controlled peptide-coupling reactions
  4. Introduction of the required sulfonyl-containing structural component
  5. Formation of key amide and urea linkages
  6. Reaction monitoring
  7. Deprotection and purification
  8. Isolation of the API
  9. Crystallization or suitable purification
  10. Filtration and washing
  11. Controlled drying
  12. Milling, where required
  13. Final analytical testing
  14. GMP-compliant packaging

Quality Control Testing

Typical Narlaprevir API testing may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Degradation products
  • Residual solvents
  • Water content
  • Elemental impurities
  • Chiral/chemical purity, where applicable
  • Particle-size distribution, where applicable
  • Stability testing

Storage

Store Narlaprevir API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.

Final storage conditions should be established according to validated stability data, the applicable API specification and the manufacturer's SDS.

Pharmaceutical Research

Narlaprevir is relevant to research involving:

  • HCV NS3/4A protease
  • Direct-acting antivirals
  • Hepatitis C virus
  • Viral protease inhibition
  • Antiviral drug discovery
  • HCV replication
  • Antiviral resistance
  • Protease inhibitor structure-activity research
  •  

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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