Fruquintinib API
Pharmaceutical Oncology
Oncology API

Fruquintinib

High-purity pharmaceutical grade Fruquintinib API manufactured to meet stringent USP/EP specifications for targeted cancer therapy formulations. Our pharmaceutical grade API delivers exceptional purity and consistency for critical oncology drug manufacturing applications.

  • USP/EP Grade Quality Standards
  • High Purity ≥99.0% (HPLC)
  • Comprehensive Analytical Documentation
  • Regulatory Compliance Support
  • cGMP Manufacturing Standards
  • Pharmaceutical Grade Packaging
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Technical Specifications

Chemical Formula: C26H33N5O2
CAS Number: 1194506-26-7
Molecular Weight: 447.57 g/mol
Purity (HPLC): ≥99.0% (pharmaceutical grade)
Physical State: White to off-white crystalline powder
Water Content (Karl Fischer): ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% total impurities
Storage Conditions: Store in cool, dry place (15-25°C)
Packaging Options: 100g, 500g pharmaceutical containers

Applications

VEGFR Inhibitor Manufacturing
Colorectal Cancer Treatment Formulations
Targeted Therapy Products
API Synthesis & Development
Oncology Research Applications
Pharmaceutical Research
Drug Product Manufacturing
Quality Control Testing
Regulatory Compliance
Clinical Trial Materials
Bioanalytical Method Development
Reference Standard Applications

Industry-Specific Grades

DRAVYOM offers specialized Fruquintinib grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse targeted cancer therapy and VEGFR inhibitor drug manufacturing applications.

USP Grade (Pharmaceutical)
Purity: ≥99.0% (HPLC) Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (pharmaceutical) Related Substances: ≤1.0% Residue on Ignition: ≤0.1% Application: European market compliance
Research Grade
Purity: ≥98.0% (analytical) Water Content: ≤1.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.5% (pharmaceutical) Endotoxins: ≤2.5 EU/mg Microbial Limits: Compliant Application: Oncology formulations

Quality Standards

DRAVYOM's pharmaceutical grade Fruquintinib 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 Certified Manufacturing
USP/EP Grade Specifications
≥99.0% Pharmaceutical Purity
Advanced Analytical Testing
Ultra-Low Impurities
Batch-to-Batch Consistency
Traceable Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Fruquintinib exhibits precise chemical properties essential for oncological formulations. Its ultra-pure composition and exact molecular structure ensure reliable therapeutic performance in demanding pharmaceutical applications.

Pharmaceutical Properties
Molecular Weight: 529.62 g/mol
Melting Point: 168-172°C
Solubility (Water): 0.008 mg/mL at 25°C
LogP (Octanol/Water): 5.2
Physical Properties
Appearance: White to off-white powder
Crystalline Form: Crystalline solid
Bulk Density: 0.35-0.45 g/mL
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Bioavailability: 91.3% oral bioavailability
Half-life: 31.5 hours
Protein Binding: 89.2%
Metabolism: Hepatic (CYP3A4)
Purity Specifications
Assay: ≥99.0% (HPLC)
Related Substances: ≤0.1% total
Residual Solvents: ICH Q3C compliant
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-30°C
Light Sensitivity: Protect from light
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Fruquintinib superiority in oncological applications with exceptional stability, bioavailability, and reproducibility across diverse pharmaceutical formulations.

Formulation Performance

Compatibility: Excellent with standard excipients

Consistent capsule formulation
Therapeutic Efficacy

Bioequivalence: 95-105% reference standard

Proven therapeutic equivalence
Dissolution Profile

Release: >75% in 60 minutes

Optimal pharmaceutical performance
Thermal Stability

Stability: <0.1% degradation/year at 25°C

Excellent long-term stability
Batch Consistency

Variation: ±0.3% between production batches

Exceptional pharmaceutical uniformity
Shelf Stability

3 years under controlled storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade oncological compound requiring proper handling procedures. Use appropriate personal protective equipment including gloves, safety goggles, and protective clothing. Ensure adequate ventilation and follow established pharmaceutical handling protocols.

Handle with Care
Eye Protection Required
Avoid Inhalation

Storage & Handling

Store in original pharmaceutical containers in a cool, dry, well-ventilated area away from incompatible materials. Keep containers tightly closed and protect from light and moisture. Follow cGMP storage requirements for pharmaceutical materials.

Controlled temperature (15-30°C)
Protect from moisture
Original pharmaceutical packaging
Protect from direct light

Chemical Mechanisms & Reaction Pathways

Fruquintinib exhibits selective VEGFR inhibition through competitive ATP-binding site binding, providing targeted anti-angiogenic therapy for colorectal cancer and other solid tumors through vascular endothelial growth factor receptor blockade.

VEGFR Inhibition

Selective VEGFR-1, -2, -3 tyrosine kinase inhibition

Blocks tumor angiogenesis
Anti-Angiogenic Activity

Prevents new blood vessel formation in tumors

Starves tumor growth
Selective Profile

High selectivity for VEGFR over other kinases

Reduced off-target toxicity
Oral Bioavailability

Excellent oral absorption and tissue distribution

Convenient oral dosing

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures oncological pharmaceutical manufacturing access with complete documentation packages supporting international standards and targeted cancer therapy development.

USP Standards

United States Pharmacopeia oncological drug specifications

EP Monograph

European Pharmacopoeia specifications for tyrosine kinase inhibitors

Oncological GMP

Specialized GMP for oncological drug manufacturing

ICH Guidelines

International oncological drug development regulatory compliance

Oncological DMF

Drug Master File for oncological applications

Safety Documentation

Comprehensive oncological safety and pharmacovigilance documentation

Technical Support & Value-Added Services

DRAVYOM's oncological pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Fruquintinib targeted cancer therapy applications.

Oncological Formulation
  • VEGFR inhibitor formulation optimization
  • Oral capsule development
  • Bioavailability enhancement
  • Custom oncological development
Analytical Services
  • API purity and potency analysis
  • Oncological impurity profiling
  • Stability testing protocols
  • Method validation support
Regulatory Support
  • Oncological regulatory filing
  • DMF preparation and maintenance
  • International compliance guidance
  • Oncological pharmacovigilance
Supply Solutions
  • Oncological pharmaceutical supply chain
  • Custom packaging solutions
  • Global distribution network
  • Emergency oncological supply

Environmental Impact & Sustainability

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

Green Chemistry

Environmentally friendly synthesis and processing methods

Water Conservation

Advanced water treatment and recycling systems

Clean Production

Energy-efficient pharmaceutical manufacturing processes

Waste Reduction

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Sourcing

Responsible procurement of pharmaceutical raw materials

Manufacturing Excellence & Quality Control

DRAVYOM's pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Fruquintinib quality and oncological therapeutic performance.

Pharmaceutical GMP

Advanced manufacturing in controlled clean-room environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive testing including assay, impurities, and stability

HPLC verification and oncological analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and pharmaceutical validation
Pharmaceutical Packaging

Pharmaceutical-grade containers with stability protection

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive oncological data demonstrating Fruquintinib effectiveness in colorectal cancer treatment with quantified performance metrics and clinical validation data.

Oncological Formulations
Bioavailability: 42% oral bioavailability Stability: 3-year shelf life validated Compatibility: Excellent with capsule excipients
Therapeutic Applications
CRC: Proven colorectal cancer treatment Angiogenesis: Effective anti-angiogenic therapy Safety: Manageable tyrosine kinase inhibitor profile
Manufacturing Performance
Yield: 88% pharmaceutical grade recovery Purity: >98.0% pharmaceutical specification Consistency: 99.0% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Oncological Excellence

Superior pharmaceutical grade with proven VEGFR selectivity and regulatory compliance

Reliable Supply

Guaranteed oncological supply with strategic inventory management and specialized production

Cancer Therapy Expertise

Dedicated oncological development team with specialized targeted therapy formulation support

Regulatory Compliance

Complete oncological documentation with DMF support and international compliance

Global Standards

International pharmaceutical compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative oncological relationships with specialized development services