Midostaurin API
Pharmaceutical Oncology
Oncology API

Midostaurin

High-purity pharmaceutical grade Midostaurin 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: C35H30N4O4
CAS Number: 120685-11-2
EINECS Number: Not applicable
Molecular Weight: 570.64 g/mol
Physical State: Off-white to light yellow powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 134-138°C
pH (1% solution): Not applicable (poorly soluble)
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Solubility: Soluble in organic solvents
Storage Conditions: Store below 25°C, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 1g, 5g, 25g amber containers

Applications

Acute Myeloid Leukemia
FLT3 Inhibitor
Targeted Cancer Therapy
Oncology Treatment
Cancer Research
Clinical Trials
Pharmaceutical Manufacturing
Protein Kinase Inhibition
Oncology Research
Regulatory Submissions
Quality Control
Reference Standards

Industry-Specific Grades

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

USP Grade (United States Pharmacopeia)
Purity: ≥99.0% (HPLC) Loss on Drying: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (HPLC) Melting Point: 134-138°C Residue on Ignition: ≤0.1% Application: EU regulatory submissions
Oncology Research Grade
Purity: ≥99.5% (HPLC) Enhanced FLT3 inhibition Low endotoxin levels Application: Cancer research
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Midostaurin 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
Light-Protected Processing
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical Grade Midostaurin exhibits exceptional chemical properties essential for oncological applications. Its optimal molecular structure and superior stability characteristics ensure reliable performance in demanding cancer therapy formulations.

Molecular Properties
Molecular Weight: 570.64 g/mol
Molecular Formula: C35H30N4O4
LogP (Octanol/Water): 3.2
Solubility (Water): Practically insoluble
Physical Properties
Melting Point: 134-138°C
Appearance: Orange to red crystalline solid
Light Sensitivity: Photosensitive
Polymorphic Forms: Form I (stable)
Pharmaceutical Properties
Bioavailability: Good with food
Protein Binding: ~95%
Half-life: 20-30 hours
Target: FLT3, PKC, KIT
Quality Specifications
Purity (HPLC): ≥99.0%
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 2-8°C (refrigerated)
Light Protection: Required
Moisture Protection: Required

Performance Characteristics

Detailed performance metrics demonstrate Midostaurin superiority in oncological applications with exceptional FLT3 inhibition potency, bioavailability, and therapeutic efficacy across diverse cancer treatment protocols.

FLT3 Inhibition

IC50: 5-10 nM (potent kinase inhibition)

Selective FLT3-ITD targeting
Cellular Activity

Growth inhibition in AML cell lines

Effective anti-proliferative activity
Formulation Compatibility

Compatible with standard excipients

Stable in capsule formulations
Thermal Stability

Stable under controlled storage conditions

Suitable for pharmaceutical processing
Batch Consistency

Excellent lot-to-lot reproducibility

Reliable pharmaceutical performance
Anti-Cancer Efficacy

Proven clinical efficacy in AML treatment

FDA-approved therapeutic performance

Safety Information

Potent 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 materials.

Cytotoxic Agent
Containment Required
Specialized PPE Required

Storage & Handling

Store in original containers under refrigerated conditions (2-8°C) in a dry, dark place. Protect from light and moisture. Handle in controlled environments with proper containment systems and specialized safety protocols for cytotoxic materials.

Refrigerated storage (2-8°C)
Protect from light
Contained handling required
Protect from moisture

Chemical Mechanisms & Reaction Pathways

Midostaurin exhibits potent antineoplastic activity through multi-target kinase inhibition and apoptosis induction pathways, enabling precise oncological applications with selective cellular targeting and anti-leukemic properties.

FLT3 Kinase Inhibition

Selective inhibition of FLT3 receptor tyrosine kinase

Targets mutated FLT3 in acute myeloid leukemia
PKC Inhibition

Inhibits protein kinase C isoforms

Disrupts cell proliferation signaling pathways
Apoptosis Induction

Triggers programmed cell death in leukemic cells

Selective elimination of malignant cells
Multi-target Activity

Inhibits multiple kinases including Kit and PDGFR

Broad spectrum anti-cancer activity

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia oncology pharmaceutical grade standards compliance

EP Standards

European Pharmacopoeia specifications for kinase inhibitor pharmaceutical manufacturing

cGMP Manufacturing

Current Good Manufacturing Practice certified oncology API production facility

ICH Guidelines

International Conference on Harmonisation oncology quality standards

DMF Support

Drug Master File documentation for oncology regulatory submissions

Safety Documentation

Complete oncology safety and handling documentation package

Technical Support & Value-Added Services

DRAVYOM's oncology pharmaceutical development team provides comprehensive formulation support, kinase inhibitor handling guidance, and regulatory support to optimize Midostaurin performance in your oncology pharmaceutical applications.

Formulation Development
  • Oral formulation optimization
  • Capsule formulation design
  • Bioavailability enhancement strategies
  • Stability enhancement guidance
Analytical Services
  • Certificate of Analysis verification
  • Kinase inhibitor impurity profiling
  • Stability method validation
  • Light stability evaluation
Technical Support
  • Oncology API handling consultation
  • cGMP compliance for oncology manufacturing
  • Containment system design
  • Regulatory documentation support
Supply Solutions
  • Specialized oncology packaging
  • Light-protected logistics
  • Emergency oncology supply
  • Global pharmaceutical distribution

Environmental Impact & Sustainability

Our Midostaurin production emphasizes environmental responsibility through sustainable oncology pharmaceutical manufacturing practices, specialized waste management, and comprehensive environmental impact control for oncology operations.

Oncology Waste Management

Specialized treatment and disposal of oncology pharmaceutical waste

Wastewater Treatment

Advanced oncology pharmaceutical wastewater treatment systems

Containment Systems

Closed-loop manufacturing with environmental protection

Resource Recovery

Solvent recovery and raw material optimization programs

ISO 14001

Environmental management system for oncology production

Safe Transport

Specialized logistics minimizing environmental impact

Manufacturing Excellence & Quality Control

DRAVYOM's specialized oncology pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Midostaurin quality and potency across all production batches.

Production Process

Advanced synthesis and purification in contained oncology environment

Multi-stage crystallization for oncology pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing including kinase inhibitor activity analysis

HPLC verification and bioactivity analysis
Quality Systems

ISO 9001:2015 quality management with oncology pharmaceutical accreditation

Specialized oncology API quality systems
Packaging Control

Specialized light-resistant containers with moisture protection

Light and moisture protection systems

Market Applications & Performance Data

Comprehensive oncology pharmaceutical development data demonstrating Midostaurin effectiveness across diverse therapeutic applications with quantified performance metrics and kinase inhibitor development validations.

Oncology Manufacturing
Bioavailability: Variable, food-dependent Stability: Light-sensitive API Purity: >99.0% oncology grade
Clinical Applications
Efficacy: Proven FLT3-mutated AML treatment Safety: Established oncology toxicity profile Regulatory: Oncology approvals worldwide
Manufacturing Capabilities
Capacity: Controlled oncology production batches Consistency: <0.5% batch-to-batch variation Compliance: 100% oncology cGMP adherence

DRAVYOM Competitive Advantages

Oncology Expertise

Specialized oncology manufacturing with ultra-low impurities and exceptional kinase inhibitor pharmaceutical performance

Reliable Supply

Guaranteed availability with specialized inventory management and oncology-grade production scheduling

Kinase Inhibitor Expertise

Dedicated oncology pharmaceutical development team with kinase inhibitor formulation expertise

Quality Assurance

Comprehensive certificates with complete analytical data and oncology handling documentation

Global Standards

International compliance with USP, EP, and ICH specifications for worldwide oncology pharmaceutical acceptance

Partnership Approach

Collaborative relationships with oncology pharmaceutical companies and custom kinase inhibitor API development