Rivaroxaban
Pharmaceutical Premium
Pharmaceutical API

Rivaroxaban

High-purity pharmaceutical grade Rivaroxaban manufactured to meet stringent USP/EP specifications for pharmaceutical formulations and research applications. Our pharmaceutical grade material delivers exceptional purity and consistency for critical pharmaceutical manufacturing.

  • USP/EP Grade Specifications
  • High Purity (≥99.0%)
  • Comprehensive Analytical Testing
  • Regulatory Compliance Documentation
  • Pharmaceutical Manufacturing Grade
  • Quality Assurance Certified
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Technical Specifications

Chemical Formula: C19H18ClN3O5S
CAS Number: 366789-02-8
EINECS Number: Not applicable
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to pale yellow crystalline powder
Molecular Weight: 435.88 g/mol
Melting Point: 206-208°C
pH (1% solution): 5.0-7.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Slightly soluble in water
Storage Conditions: Store at 15-30°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 100g, 500g, 1kg containers

Applications

Anticoagulant Therapy
Blood Clot Prevention
Oral Tablet Formulations
Extended-Release Formulations
DVT Prevention
Factor Xa Inhibitor
Atrial Fibrillation
Stroke Prevention
Cardiovascular Research
Clinical Trials
Coagulation Drug Development
Pharmaceutical Research

Industry-Specific Grades

DRAVYOM offers specialized Rivaroxaban grades tailored for specific cardiovascular applications, ensuring optimal Factor Xa inhibitor activity and regulatory compliance across diverse pharmaceutical formulations.

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: EP limits Application: European market compliance
Research Grade
Purity: ≥98.0% Activity: Verified Stability: Enhanced Application: Cardiovascular research
Anticoagulant Grade
Purity: ≥99.5% Bioavailability: Optimized Stability: Enhanced Application: Blood thinning therapy

Quality Standards

DRAVYOM's Rivaroxaban is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and FDA guidelines for cardiovascular therapy applications.

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

Advanced Chemical Properties & Performance

Pharmaceutical Grade Rivaroxaban exhibits exceptional chemical properties essential for anticoagulation applications. Its potent factor Xa inhibitor structure and superior stability characteristics ensure reliable performance in demanding thrombosis prevention and treatment formulations.

Molecular Properties
Molecular Weight: 435.88 g/mol
Molecular Formula: C19H18ClN3O5S
LogP (Octanol/Water): 1.5
pKa: 3.2
Physical Properties
Melting Point: 228-232°C
Appearance: White to off-white crystalline powder
Solubility (Water): Practically insoluble
Bulk Density: 0.50-0.60 g/cm³
Pharmaceutical Properties
Bioavailability: 80-100%
Protein Binding: 92-95%
Half-life: 5-9 hours (healthy adults)
Mechanism: Selective factor Xa inhibition
Quality Specifications
Purity (HPLC): ≥99.0%
Water Content: ≤0.5%
Related Substances: ≤1.0%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-25°C
Light Sensitivity: Store in light-resistant containers
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate Rivaroxaban superiority in anticoagulation applications with exceptional factor Xa inhibition, predictable pharmacokinetics, and therapeutic efficacy across diverse thrombosis prevention and treatment protocols.

Factor Xa Inhibition

Selective and reversible factor Xa inhibition

Precise anticoagulation control
Thrombosis Prevention

Effective prevention of blood clots

VTE and stroke prevention
Predictable Kinetics

Consistent and predictable pharmacokinetics

No routine monitoring required
Oral Administration

Convenient once or twice daily dosing

Patient compliance advantage
Clinical Efficacy

FDA-approved for multiple indications

Proven cardiovascular benefits
Safety Profile

Favorable bleeding risk profile

Reversible anticoagulation

Safety Information

Potent anticoagulant pharmaceutical active ingredient requiring specialized handling protocols. Handle in controlled environments with appropriate containment systems. Use proper personal protective equipment and follow established safety protocols for anticoagulant compounds.

Anticoagulant Agent
Controlled Handling Required
Standard PPE Required

Storage & Handling

Store in tightly closed, light-resistant containers in a cool, dry place away from direct sunlight. Maintain controlled room temperature storage and ensure protection from moisture and humidity to preserve pharmaceutical quality and anticoagulant potency.

Controlled room temperature (15-25°C)
Protect from light
Light-resistant containers
Store in dry conditions

Chemical Mechanisms & Reaction Pathways

Rivaroxaban exhibits specific Factor Xa inhibitor mechanisms essential for anticoagulation therapy. Its molecular structure enables selective enzyme inhibition with predictable antithrombotic therapeutic responses.

Factor Xa Inhibition

Direct and reversible Factor Xa inhibition mechanism

Anticoagulation pathway disruption
Metabolic Pathways

Hepatic metabolism via CYP3A4/5 and CYP2J2 enzyme systems

Multiple clearance pathways
Coagulation Selectivity

Specific targeting of coagulation cascade Factor Xa

Targeted anticoagulation
Pharmacological Effects

Potent anticoagulant with predictable dose-response

Thromboembolism prevention

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia pharmaceutical standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical quality

ICH Guidelines

International Conference on Harmonization standards compliance

GMP Certification

Good Manufacturing Practices certified production facility

DMF Support

Drug Master File documentation for regulatory submissions

CEP Available

Certificate of Suitability to European Pharmacopoeia monographs

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, regulatory assistance, and technical services to optimize pharmaceutical performance in your specific drug development applications.

Formulation Development
  • Dosage form optimization support
  • Stability testing guidance
  • Bioavailability enhancement
  • Custom formulation development
Analytical Services
  • Method development and validation
  • Impurity profiling and identification
  • Stability indicating methods
  • Dissolution testing support
Regulatory Support
  • Regulatory submission assistance
  • DMF preparation and maintenance
  • Pharmacovigilance support
  • Global registration strategy
Supply Solutions
  • Pharmaceutical supply chain management
  • Cold chain logistics
  • Custom packaging solutions
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical production emphasizes environmental responsibility through sustainable manufacturing practices, green chemistry principles, and comprehensive environmental impact management for pharmaceutical operations.

Green Chemistry

Sustainable synthetic routes with minimal environmental impact

Water Management

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Packaging

Recyclable pharmaceutical packaging solutions

Manufacturing Excellence & Quality Control

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

Production Process

Advanced synthesis and purification in GMP-controlled clean-room environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive testing protocol including purity, potency, and impurity profiling

HPLC, GC-MS, and spectroscopic analysis
Quality Systems

ISO 9001:2015 and GMP quality management systems

Continuous improvement and validation protocols
Packaging Control

Pharmaceutical-grade packaging with controlled atmosphere

Contamination prevention and stability protection

Market Applications & Performance Data

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

Pharmaceutical Development
Formulation Success: 95+ formulations developed Regulatory Approvals: 100+ successful submissions Quality Consistency: 99.9% batch compliance
Research Applications
Clinical Studies: 200+ supported trials Publication Support: 150+ peer-reviewed papers Innovation: Custom API development
Commercial Manufacturing
Scale-up Success: 100% process transfers Supply Reliability: 99.8% on-time delivery Cost Optimization: 25% average cost reduction

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds pharmacopeial specifications with superior purity and pharmaceutical performance

Reliable Supply

Guaranteed pharmaceutical availability with strategic inventory and GMP production scheduling

Development Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Regulatory Assurance

Complete regulatory packages with DMF support and global registration assistance

Global Standards

International compliance with USP, EP, and ICH standards for worldwide market access

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services