Sunitinib Maleate API
Pharmaceutical Oncology
Oncology API

Sunitinib Maleate

High-purity pharmaceutical grade Sunitinib Maleate 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: C22H27FN4O2·C4H4O4
CAS Number: 341031-54-7
EINECS Number: Not Available
Molecular Weight: 532.56 g/mol
Physical State: Yellow to orange crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 170-174°C
pH (1% solution): 2.5-4.0
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 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
Renal Cell Carcinoma Treatment
GIST Treatment
Multi-Kinase Inhibitor Research
Hospital Oncology Units
Specialty Pharmaceutical Manufacturing
Targeted Therapy Drugs
Cancer Research Studies
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

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

USP Grade (United States Pharmacopeia)
Purity: ≥99.0% (HPLC) Related Substances: ≤1.0% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (HPLC) Impurities: Individual ≤0.5% Loss on Drying: ≤0.5% Application: EU regulatory submissions
Oncology Research Grade
Purity: ≥99.5% (HPLC) Water Content: ≤0.2% Residue on Ignition: ≤0.05% Application: Cancer research studies
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Sunitinib Maleate 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
Ultra-Low Impurity Levels
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Sunitinib Maleate exhibits exceptional multi-kinase inhibitor properties essential for oncology applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding cancer treatment formulations.

Molecular Properties
Molecular Weight: 532.56 g/mol
LogP: 3.2
pKa: 8.95
Bioavailability: 89%
Physical Properties
Melting Point: 265-270°C
Solubility (Water): 25 mg/mL
Crystalline Form: Stable polymorph
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
VEGFR IC50: 80 nM
PDGFR IC50: 60 nM
Selectivity: Multi-kinase inhibitor
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 Sunitinib Maleate superiority in oncology applications with exceptional multi-kinase inhibition, bioavailability, and reproducibility across diverse cancer treatment formulations.

Kinase Inhibition

IC50: 60-80 nM for multiple kinases

Broad-spectrum kinase inhibition
Bioavailability

Oral: 89% absolute bioavailability

Excellent drug absorption
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

Potent oncology API requiring specialized handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for cytotoxic APIs and ensure proper waste disposal procedures.

Cytotoxic 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 cytotoxic API handling.

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

Chemical Mechanisms & Reaction Pathways

Sunitinib Maleate functions as a multi-targeted receptor tyrosine kinase inhibitor through competitive ATP binding, enabling precise therapeutic interventions with well-characterized pharmacological pathways and metabolic processes.

Kinase Inhibition

Competitive inhibition of VEGFR, PDGFR, and c-KIT receptor tyrosine kinases

Blocks angiogenesis and tumor growth signaling
ATP Binding Site

Reversible binding to ATP-binding pocket of target kinases

Prevents phosphorylation cascade activation
Metabolic Pathways

Hepatic metabolism via CYP3A4 forming active N-desethyl metabolite

Active metabolite contributes to therapeutic effect
Cellular Uptake

Facilitated transport across cell membranes via organic cation transporters

Enables intracellular kinase inhibition

Regulatory Compliance & Documentation

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

USP/EP Standards

United States Pharmacopeia and European Pharmacopoeia compliance

ICH Guidelines

International Conference on Harmonisation pharmaceutical standards

cGMP Manufacturing

Current Good Manufacturing Practice certified production

Global Registration

DMF filings and regulatory support for worldwide markets

Stability Studies

Long-term and accelerated stability data packages

Impurity Profiling

Comprehensive impurity identification and qualification

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory assistance to optimize pharmaceutical manufacturing processes and ensure successful product development.

Formulation Development
  • API compatibility studies
  • Excipient interaction analysis
  • Stability-indicating method development
  • Formulation optimization support
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Forced degradation studies
  • Bioanalytical method development
Technical Support
  • Pharmaceutical development consultation
  • Manufacturing process optimization
  • Quality system implementation
  • Regulatory filing support
Supply Solutions
  • Clinical trial material supply
  • Commercial scale manufacturing
  • Just-in-time delivery programs
  • Global supply chain management

Environmental Impact & Sustainability

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

Green Chemistry

Optimized synthetic routes with minimal environmental impact

Solvent Recovery

Advanced solvent recovery and recycling systems

Energy Efficiency

Renewable energy integration in manufacturing processes

Waste Management

Comprehensive pharmaceutical waste treatment protocols

ISO 14001

Environmental management system certified operations

Packaging Innovation

Sustainable packaging materials and design optimization

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced process control technology and comprehensive quality systems to ensure consistent API quality and performance across all production batches.

cGMP Manufacturing

Current Good Manufacturing Practice compliant production in controlled environments

FDA and EMA inspected pharmaceutical facilities
Quality Control

Multi-point quality control testing including assay, related substances, and residual solvents

HPLC, GC-MS, and NMR analytical verification
Quality Systems

ISO 9001:2015 quality management with pharmaceutical quality system standards

Continuous improvement and change control procedures
Packaging Systems

Primary packaging in controlled atmosphere with tamper-evident sealing

Light protection and moisture barrier packaging

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating API effectiveness across diverse therapeutic applications with quantified performance metrics and regulatory validation studies.

Pharmaceutical Manufacturing
Purity: >99.5% pharmaceutical grade Stability: 36-month shelf life data Compliance: 100% regulatory specifications
Research & Development
Research Support: 200+ published studies Method Validation: Cross-platform verification Innovation: Advanced analytical techniques
Clinical Applications
Clinical Grade: Phase I-III trial supply Regulatory Success: Global market approvals Manufacturing: Scalable production processes

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with exceptional purity and pharmaceutical performance standards

Reliable Supply Chain

Guaranteed pharmaceutical-grade availability with strategic inventory management and production scheduling

Development Expertise

Dedicated pharmaceutical development team provides formulation and analytical method support

Regulatory Excellence

Comprehensive documentation packages with global regulatory filing support and validation

Global Standards

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

Partnership Excellence

Collaborative pharmaceutical development relationships with custom API synthesis and scale-up services