Nafamostat Mesilate USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Nafamostat Mesilate USP/EP

High-purity pharmaceutical grade Nafamostat Mesilate manufactured under stringent cGMP conditions. This serine protease inhibitor API is essential for antiviral therapy and anticoagulation, particularly in viral infection treatment, providing reliable quality and regulatory compliance.

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

Chemical Formula: C19H17N5O2·CH4O3S
CAS Number: 82956-11-4
EINECS Number: Not assigned
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white powder
Molecular Weight: 491.53 g/mol
Melting Point: 144-148°C (with decomposition)
pH (1% solution): 6.5-8.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Soluble in water, methanol
Storage Conditions: Store at 2-8°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 1g, 5g, 25g, 100g vials

Applications

Antiviral Therapy
Serine Protease Inhibition
Anticoagulation Therapy
COVID-19 Treatment
Pharmaceutical Research
Injectable Formulations
Clinical Applications
Protease Research
Enzymatic Studies
Drug Development
Pharmacological Research
Regulatory Studies

Industry-Specific Grades

DRAVYOM offers specialized Nafamostat Mesilate grades tailored for specific pharmaceutical applications, ensuring optimal performance and regulatory compliance across diverse therapeutic areas.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% Related Substances: ≤1.0% Residual Solvents: ICH limits Application: European market compliance
Research Grade
Purity: ≥98.0% Activity: >95% inhibition Endotoxin: ≤1 EU/mg Application: R&D, preclinical studies
cGMP Grade
Purity: ≥99.5% Bioburden: ≤100 CFU/g Full validation: DMF available Application: Commercial manufacturing

Quality Standards

DRAVYOM's Nafamostat Mesilate is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and ICH guidelines. Our pharmaceutical-grade production ensures consistent quality and regulatory compliance.

cGMP Manufacturing Standards
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
Antiviral Activity Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Cold Chain Storage & Shipping

Advanced Chemical Properties & Performance

Nafamostat Mesilate exhibits exceptional serine protease inhibitor properties essential for antiviral applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding antiviral formulations.

Molecular Properties
Molecular Weight: 539.58 g/mol
LogP: 1.8
pKa: 8.9
Bioavailability: 2%
Physical Properties
Melting Point: 165-170°C
Solubility (Water): 50 mg/mL
Crystalline Form: Stable mesilate salt
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Trypsin IC50: 0.27 μM
TMPRSS2 Inhibition: Potent
Selectivity: Serine protease selective
Stability: Stable in solid state
Purity Specifications
Assay: ≥99.0%
Related Substances: ≤0.5%
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable at room temperature
pH Stability: Stable pH 4-7

Performance Characteristics

Detailed performance metrics demonstrate Nafamostat Mesilate superiority in antiviral applications with exceptional protease inhibition, antiviral activity, and reproducibility across diverse formulations.

Protease Inhibition

IC50: 0.27 μM (trypsin)

Potent protease inhibition
Antiviral Activity

TMPRSS2: Strong inhibition

Broad antiviral spectrum
Stability

Solid state: >5 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 15-40°C processing

Stable during formulation
Batch Reproducibility

Variation: ±0.5% between batches

Consistent lot-to-lot performance
Shelf Stability

5 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 antiviral 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.

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

Chemical Mechanisms & Reaction Pathways

Nafamostat mesilate exhibits potent anticoagulant and anti-inflammatory properties through selective serine protease inhibition, providing therapeutic efficacy in critical care applications with optimized pharmacokinetic profiles.

Serine Protease Inhibition

Selective inhibition of thrombin, plasmin, and complement proteases

Broad-spectrum anticoagulant mechanism
Coagulation Pathway

Interruption of both intrinsic and extrinsic coagulation cascades

Comprehensive anticoagulant effects
Complement System

Inhibition of complement activation and inflammatory response

Anti-inflammatory therapeutic benefits
Pharmacokinetic Profile

Rapid action with predictable clearance kinetics

Precise dosing and monitoring capabilities

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical acceptance with complete documentation packages supporting international drug development and manufacturing requirements.

USP Specifications

United States Pharmacopeia pharmaceutical grade compliance

EP Standards

European Pharmacopoeia specifications and testing protocols

ICH Guidelines

International harmonized pharmaceutical development standards

Global Regulatory

Multi-regional pharmaceutical registration support

DMF Support

Drug Master File preparation and regulatory submission

GMP Compliance

Good Manufacturing Practice certified production

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory assistance to optimize Nafamostat mesilate performance in pharmaceutical applications.

Formulation Development
  • Stability enhancement strategies
  • Bioavailability optimization
  • Excipient compatibility studies
  • Dosage form development
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Stability testing programs
  • Dissolution testing support
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Flexible packaging options
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

Our Nafamostat mesilate production emphasizes environmental responsibility through sustainable pharmaceutical manufacturing practices, waste minimization, and comprehensive environmental impact management.

Green Chemistry

Environmentally conscious synthesis with minimal waste

Water Management

Advanced wastewater treatment and recycling systems

Energy Efficiency

Optimized manufacturing processes with reduced energy consumption

Waste Reduction

Comprehensive waste minimization and disposal protocols

ISO 14001

Environmental management system certified production

Carbon Footprint

Reduced environmental impact through sustainable practices

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Nafamostat mesilate quality and performance across all production batches.

GMP Production

Good Manufacturing Practice certified facility with controlled environments

Pharmaceutical-grade production standards
Quality Testing

Comprehensive analytical testing including impurity profiling and stability

HPLC, LC-MS, and pharmacopeial methods
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Controlled atmosphere packaging with stability maintenance

Moisture and light protection systems

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Nafamostat mesilate effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Manufacturing
Bioavailability: Rapid intravenous action Stability: Controlled temperature storage Purity: >99.5% pharmaceutical grade
Drug Development
Formulation Support: Injectable preparations Regulatory Success: Global approvals achieved Innovation: Custom synthesis capabilities
Clinical Applications
Efficacy: Potent anticoagulant activity Safety: Established clinical profile Precision: Predictable pharmacokinetics

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with pharmaceutical-grade quality and performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production

Development Expertise

Dedicated pharmaceutical team provides formulation development and regulatory support

Quality Assurance

Comprehensive documentation with pharmaceutical-grade certificates and regulatory compliance

Global Standards

International compliance with USP, EP, and ICH guidelines for worldwide acceptance

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services