Sorafenib Tosylate USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Sorafenib Tosylate USP/EP

High-purity pharmaceutical grade Sorafenib Tosylate manufactured under stringent cGMP conditions. This multikinase inhibitor API is essential for oncology applications, particularly in hepatocellular carcinoma and renal cell carcinoma treatment, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥98.5% Purity (HPLC)
  • Comprehensive COA Documentation
  • Multikinase Inhibitor for Oncology
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C21H16ClF3N4O3·C7H8O3S
CAS Number: 475207-59-1
Molecular Weight: 637.03 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥98.5% (USP/EP Grade)
Loss on Drying: ≤0.5%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.5% (total impurities)
Storage Conditions: Store at room temperature, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 25g, 50g, 100g pharmaceutical containers

Applications

Oral Tablet Formulations
Capsule Formulations
Hepatocellular Carcinoma
Renal Cell Carcinoma
Oncology Research
Cancer Treatment Centers
Multikinase Inhibition
Targeted Cancer Therapy
Clinical Oncology
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Sorafenib Tosylate grades tailored for specific oncology pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse cancer treatment applications.

USP Grade (United States Pharmacopeia)
Purity: ≥98.5% (HPLC) Related Substances: ≤1.5% Heavy Metals: ≤10 ppm Application: FDA-compliant oncology formulations
EP Grade (European Pharmacopoeia)
Purity: ≥98.5% (HPLC) Loss on Drying: ≤0.5% Chloride: ≤0.5% Application: EU regulatory submissions
Clinical Grade
Purity: ≥99.0% (HPLC) Endotoxin: ≤0.25 EU/mg Sterility: Compliant Application: Clinical trials
Research Grade
Purity: ≥98.0% (HPLC) Activity: Confirmed Documentation: Research COA Application: Preclinical research

Quality Standards

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

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
≥98.5% HPLC Purity
Advanced Oncology Testing
Multikinase Inhibitor Grade
Batch-to-Batch Consistency
Comprehensive COA
Pharmaceutical Grade Packaging

Advanced Chemical Properties & Performance

Pharmaceutical Grade Sorafenib Tosylate exhibits exceptional chemical properties essential for anticancer applications. Its potent multikinase inhibitor structure and superior stability characteristics ensure reliable performance in demanding oncology formulations.

Molecular Properties
Molecular Weight: 637.03 g/mol
Molecular Formula: C21H16ClF3N4O3 · C7H8O3S
LogP (Octanol/Water): 3.8
pKa: 11.6
Physical Properties
Melting Point: 205-210°C
Appearance: White to off-white crystalline powder
Solubility (Water): Practically insoluble
Bulk Density: 0.40-0.50 g/cm³
Pharmaceutical Properties
Bioavailability: 38-49%
Protein Binding: 99.5%
Half-life: 25-48 hours
Mechanism: Multikinase 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 Sorafenib Tosylate superiority in anticancer applications with exceptional multikinase inhibition, angiogenesis suppression, and therapeutic efficacy across diverse hepatocellular and renal cell carcinoma treatment protocols.

Multikinase Inhibition

Potent inhibition of multiple kinases

RAF, VEGFR, PDGFR inhibition
Angiogenesis Suppression

Effective angiogenesis inhibition

Tumor vascularization control
Anti-proliferative

Strong anti-proliferative activity

Cancer cell growth inhibition
Extended Half-life

25-48 hour elimination half-life

Twice-daily dosing regimen
FDA Approval

FDA-approved for HCC and RCC

Proven oncological benefits
Oral Administration

Convenient oral dosing for patients

Patient compliance advantage

Safety Information

Potent anticancer 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 cytotoxic compounds.

Cytotoxic Agent
Specialized Handling Required
Cytotoxic 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 anticancer potency.

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

Chemical Mechanisms & Reaction Pathways

Sorafenib Tosylate exhibits specific multi-targeted kinase inhibition mechanisms essential for oncological therapeutic applications. Its molecular structure enables selective targeting of cellular pathways with predictable anti-cancer therapeutic responses.

Kinase Inhibition

Multi-targeted kinase inhibition including RAF, VEGFR, and PDGFR

Anti-angiogenic activity
Cellular Targeting

Selective tumor cell targeting and angiogenesis inhibition

Reduced tumor growth
Pathway Modulation

Inhibition of tumor cell proliferation and survival pathways

Enhanced therapeutic efficacy
Bioavailability

Optimized pharmaceutical formulation for oral administration

Improved patient compliance

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