Darolutamide API
Pharmaceutical Oncology
Oncology API

Darolutamide

High-purity pharmaceutical grade Darolutamide API manufactured to meet stringent USP/EP specifications for prostate cancer treatment 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
Request Quote Technical Support

Technical Specifications

Chemical Formula: C19H16ClF4N3O2
CAS Number: 1297538-32-9
Molecular Weight: 429.79 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 (15-30°C)
Packaging Options: 1kg, 5kg pharmaceutical containers

Applications

Prostate Cancer Drug Manufacturing
Androgen Receptor Antagonist
Oral Pharmaceutical Products
API Synthesis & Development
Oncology Research
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 Darolutamide grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse prostate cancer 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 Darolutamide 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
Comprehensive Impurity Control
Batch-to-Batch Consistency
Complete Documentation Package
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Darolutamide exhibits exceptional chemical properties essential for prostate cancer therapy applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Practically insoluble
LogP (octanol/water): 2.2
pKa: 13.4
Molecular Weight: 629.55 g/mol
Physical Properties
Appearance: White to pale yellow crystalline powder
Melting Point: 127-131°C
Bulk Density: 0.4-0.6 g/mL
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Bioavailability: High with food
Protein Binding: 92%
Half-life: 20 hours
Mechanism: Androgen receptor inhibitor
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤0.5% total
Water Content: ≤0.5% (Karl Fischer)
Residue on Ignition: ≤0.1%
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store below 25°C
pH Stability: Stable in neutral conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Darolutamide superiority in prostate cancer applications with exceptional androgen receptor inhibition, bioavailability, and reproducibility across diverse therapeutic protocols.

AR Inhibition

IC50: 26 nM for androgen receptor binding

Potent androgen receptor antagonism
Bioavailability

Absorption: Enhanced with food intake

Optimized for therapeutic efficacy
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 127-131°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.2% between batches

Consistent therapeutic efficacy
Shelf Stability

3 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Prescription pharmaceutical ingredient requiring professional handling. Well-established safety profile for prostate cancer therapy. Handle with pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring required during therapeutic use.

Prescription Only
Professional Use
Clinical Monitoring

Storage & Handling

Store in original containers in a cool, dry, well-ventilated area away from moisture and light. Keep containers tightly closed and maintain pharmaceutical-grade environmental controls. Use appropriate GMP handling techniques for API processing.

Cool storage (15-25°C)
Protect from moisture
Protect from light
GMP handling required

Chemical Mechanisms & Reaction Pathways

Darolutamide exhibits antineoplastic properties through nonsteroidal androgen receptor antagonism, enabling predictable anticancer effects with well-characterized pharmacokinetic and pharmacodynamic profiles.

Mechanism of Action

Nonsteroidal androgen receptor antagonism

Prostate cancer cell growth inhibition
Metabolic Pathway

Hepatic metabolism via CYP3A4 and UGT conjugation

Multiple metabolic pathways
Pharmacokinetics

Oral administration with food-enhanced absorption

Twice-daily dosing regimen
Elimination

Hepatic metabolism with renal excretion

Predictable clearance pathway

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete documentation packages supporting international drug registration and regulatory submissions.

USP Monograph

United States Pharmacopeia specifications compliance

EP Standards

European Pharmacopoeia monograph requirements

cGMP Manufacturing

Current Good Manufacturing Practices compliance

ICH Guidelines

International Council for Harmonisation standards

DMF Support

Drug Master File documentation assistance

Audit Readiness

Regulatory inspection preparation and support

Technical Support & Value-Added Services

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

Formulation Development
  • Excipient compatibility studies
  • Stability testing protocols
  • Dissolution optimization
  • Bioavailability enhancement
Analytical Services
  • Method validation support
  • Impurity identification
  • Stability indicating methods
  • Pharmaceutical testing
Technical Support
  • Regulatory compliance guidance
  • Quality assurance protocols
  • Manufacturing process support
  • Documentation preparation
Supply Solutions
  • Pharmaceutical grade scheduling
  • Global regulatory shipping
  • Custom packaging options
  • Emergency supply protocols

Environmental Impact & Sustainability

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

Waste Minimization

Optimized synthesis with minimal pharmaceutical waste

Water Treatment

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Pharmaceutical waste management guidance

ISO 14001

Environmental management system certification

Green Chemistry

Sustainable pharmaceutical synthesis methods

Manufacturing Excellence & Quality Control

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

cGMP Production

Current Good Manufacturing Practices in controlled pharmaceutical environment

FDA and WHO-GMP certified facility
Quality Testing

Comprehensive pharmaceutical testing including identity, purity, and potency

USP/EP monograph compliance verification
Quality Systems

ISO 9001:2015 with pharmaceutical quality management

Continuous improvement and validation
Packaging Control

Pharmaceutical-grade packaging with moisture protection

Stability and contamination prevention

Market Applications & Performance Data

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

Pharmaceutical Formulations
Bioavailability: 30% oral absorption Half-life: 20-hour plasma clearance Stability: 3+ years ambient storage
Clinical Applications
Efficacy: Prostate cancer treatment Safety: Well-tolerated profile Dosage: 600mg twice daily
Manufacturing Data
Purity: >99.5% pharmaceutical grade Consistency: ±0.3% batch variation Yield: >95% synthesis efficiency

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with exceptional pharmaceutical quality and performance

Reliable Supply

Guaranteed pharmaceutical-grade availability with cGMP production scheduling

Development Expertise

Dedicated pharmaceutical development team providing formulation and regulatory support

Quality Assurance

Comprehensive COA with pharmaceutical testing and regulatory compliance documentation

Global Standards

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

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom API development