Molnupiravir USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Molnupiravir USP/EP

High-purity pharmaceutical grade Molnupiravir manufactured under stringent cGMP conditions. This RNA polymerase inhibitor API is essential for antiviral therapy, particularly in viral infection treatment, providing reliable quality and regulatory compliance for modern antiviral therapeutics.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • RNA Polymerase Inhibitor for Antiviral
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C13H19N3O7
CAS Number: 2349386-89-4
EINECS Number: Not yet assigned
Molecular Weight: 329.31 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 180-185°C (decomposition)
pH (1% solution): 5.5-7.5
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% (total impurities)
Storage Conditions: Store below 25°C, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 25kg drums, 100kg containers

Applications

COVID-19 Treatment
RNA Polymerase Inhibitor
Antiviral Therapy
Emergency Use Authorization
Virology Research
Clinical Treatment
Pharmaceutical Manufacturing
Nucleoside Analog
Antiviral Research
Regulatory Submissions
Quality Control
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Molnupiravir grades tailored for specific antiviral pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse COVID-19 treatment applications.

USP Grade (United States Pharmacopeia)
Purity: ≥99.0% (HPLC) Loss on Drying: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (HPLC) pH Range: 5.5-7.5 Related Substances: ≤1.0% Application: EU regulatory submissions
Antiviral Research Grade
Purity: ≥99.5% (HPLC) Enhanced RNA activity Low endotoxin levels Application: Virology research
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Molnupiravir API is manufactured under stringent quality control protocols, meeting international pharmaceutical standards including USP, EP, and cGMP specifications. Our pharmaceutical-grade production ensures consistent performance and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
Light-Protected Processing
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Molnupiravir exhibits exceptional nucleoside analog properties essential for antiviral applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding viral RNA polymerase inhibition formulations.

Molecular Properties
Molecular Weight: 329.31 g/mol
LogP: -0.9
pKa: 3.2, 12.1
Bioavailability: ~90%
Physical Properties
Melting Point: 126-130°C
Solubility (Water): 22 mg/mL
Crystalline Form: Stable isopropyl ester
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
EC50 (SARS-CoV-2): 1.24 μM
Antiviral Activity: Potent
Selectivity: RNA virus selective
Stability: Light-sensitive
Purity Specifications
Assay: ≥99.0%
Related Substances: ≤0.5%
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 2 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Refrigerated storage
pH Stability: Stable pH 4-7

Performance Characteristics

Detailed performance metrics demonstrate Molnupiravir superiority in antiviral applications with exceptional RNA polymerase inhibition, bioavailability, and reproducibility across diverse antiviral formulations.

Antiviral Activity

EC50: 1.24 μM vs SARS-CoV-2

Potent RNA virus inhibition
Bioavailability

Oral: ~90% bioavailability

Excellent drug absorption
Stability

Solid state: >2 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 2-8°C storage

Cold chain requirement
Batch Reproducibility

Variation: ±0.5% between batches

Consistent lot-to-lot performance
Shelf Stability

2 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade antiviral API requiring careful handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for pharmaceutical APIs and ensure proper waste disposal procedures.

Pharmaceutical API
Avoid Skin Contact
Avoid Inhalation

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from light and moisture. Keep containers tightly closed and protect from direct sunlight. Use appropriate containment measures for pharmaceutical API handling.

Refrigerated storage (2-8°C)
Protect from light
Original sealed containers
Pharmaceutical containment required

Chemical Mechanisms & Reaction Pathways

Molnupiravir exhibits potent antiviral activity through RNA-dependent RNA polymerase inhibition and viral mutagenesis, enabling precise antiviral applications with enhanced RNA virus suppression and replication disruption properties.

RdRp Inhibition

Inhibits RNA-dependent RNA polymerase activity

Blocks viral RNA synthesis and replication
Viral Mutagenesis

Induces lethal mutations in viral RNA genome

Causes error catastrophe in viral replication
Nucleoside Analog

Functions as ribonucleoside analog incorporated into viral RNA

Disrupts normal RNA processing mechanisms
Broad-Spectrum Activity

Active against multiple RNA virus families

Universal antiviral mechanism of action

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international standards and antiviral pharmaceutical regulatory requirements.

USP Specifications

United States Pharmacopeia antiviral pharmaceutical grade standards compliance

EP Standards

European Pharmacopoeia specifications for antiviral pharmaceutical manufacturing

cGMP Manufacturing

Current Good Manufacturing Practice certified antiviral API production

ICH Guidelines

International Conference on Harmonisation antiviral quality standards

DMF Support

Drug Master File documentation for antiviral regulatory submissions

Safety Documentation

Complete antiviral safety and handling documentation package

Technical Support & Value-Added Services

DRAVYOM's antiviral pharmaceutical development team provides comprehensive formulation support, stability guidance, and regulatory support to optimize Molnupiravir performance in your antiviral pharmaceutical applications.

Formulation Development
  • Capsule formulation optimization
  • Oral dosage form development
  • Bioavailability enhancement strategies
  • Stability enhancement guidance
Analytical Services
  • Certificate of Analysis verification
  • Antiviral API impurity profiling
  • Stability method validation
  • Potency testing programs
Technical Support
  • Antiviral API handling consultation
  • cGMP compliance for antiviral manufacturing
  • Process optimization guidance
  • Regulatory documentation support
Supply Solutions
  • Specialized antiviral packaging
  • Cold chain logistics
  • Emergency antiviral supply
  • Global pharmaceutical distribution

Environmental Impact & Sustainability

Our Molnupiravir production emphasizes environmental responsibility through sustainable antiviral pharmaceutical manufacturing practices, waste minimization, and comprehensive environmental impact management for critical API operations.

Waste Minimization

Optimized synthesis with minimal antiviral pharmaceutical waste generation

Water Treatment

Advanced pharmaceutical wastewater treatment and recycling systems

Green Chemistry

Environmentally conscious antiviral API synthesis with emission controls

Safe Disposal

Comprehensive guidance for antiviral pharmaceutical waste management

ISO 14001

Environmental management system certified pharmaceutical production

Carbon Footprint

Reduced carbon footprint through antiviral API process optimization

Manufacturing Excellence & Quality Control

DRAVYOM's specialized antiviral pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Molnupiravir quality and potency across all production batches.

Production Process

Advanced synthesis and purification in controlled antiviral environment

Multi-stage crystallization for antiviral pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing including antiviral activity analysis

HPLC verification and antiviral potency analysis
Quality Systems

ISO 9001:2015 quality management with antiviral pharmaceutical accreditation

Specialized antiviral API quality systems
Packaging Control

Specialized moisture-resistant containers with inert atmosphere

Moisture and oxidation protection systems

Market Applications & Performance Data

Comprehensive antiviral pharmaceutical development data demonstrating Molnupiravir effectiveness across diverse therapeutic applications with quantified performance metrics and antiviral development validations.

Antiviral Manufacturing
Bioavailability: Oral administration with systemic activity Stability: Temperature-sensitive API Purity: >99.0% antiviral grade
Clinical Applications
Efficacy: Proven COVID-19 treatment Safety: Established antiviral safety profile Regulatory: Emergency use authorizations globally
Manufacturing Capabilities
Capacity: Controlled antiviral production batches Consistency: <0.5% batch-to-batch variation Compliance: 100% antiviral cGMP adherence

DRAVYOM Competitive Advantages

Antiviral Expertise

Specialized antiviral manufacturing with ultra-low impurities and exceptional RNA polymerase inhibitor pharmaceutical performance

Reliable Supply

Guaranteed availability with specialized inventory management and antiviral-grade production scheduling

Critical API Expertise

Dedicated antiviral pharmaceutical development team with nucleoside analog formulation expertise

Quality Assurance

Comprehensive certificates with complete analytical data and antiviral handling documentation

Global Standards

International compliance with USP, EP, and ICH specifications for worldwide antiviral pharmaceutical acceptance

Partnership Approach

Collaborative relationships with antiviral pharmaceutical companies and custom critical API development