Clascoterone USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Clascoterone USP/EP

High-purity pharmaceutical grade Clascoterone manufactured under stringent cGMP conditions. This androgen receptor inhibitor API is essential for acne treatment, particularly in topical acne therapy and hormonal acne management, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Androgen Receptor Inhibitor for Acne
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C21H27ClO4
CAS Number: 1451-82-7
Molecular Weight: 378.89 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

Topical Acne Treatment Manufacturing
Androgen Receptor Inhibitor Formulations
Dermatological Products
API Synthesis & Development
Hormonal Acne 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 Clascoterone grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse dermatological 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: Topical acne formulations

Quality Standards

DRAVYOM's pharmaceutical grade Clascoterone 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 Clascoterone exhibits exceptional chemical properties essential for dermatological 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): 3.8
pKa: Not applicable
UV λmax: 240 nm
Physical Properties
Melting Point: 157-159°C
Bulk Density: 0.4-0.6 g/mL
Crystalline Form: White crystalline powder
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Bioavailability: Topical application
Protein Binding: 95%
Half-life: 7-8 hours
Elimination: Hepatic metabolism
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤1.0% 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: Stable 15-30°C
Container Compatibility: HDPE, glass containers

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Clascoterone superiority in dermatological applications with exceptional androgen receptor antagonism, acne treatment efficacy, and reproducibility across diverse pharmaceutical formulations and dermatological therapeutic protocols.

Androgen Receptor Antagonism

Selective androgen receptor blockade

Effective acne treatment
Topical Stability

Stable in topical formulations

Excellent dermatological stability
Skin Penetration

Optimized dermal delivery

Consistent topical absorption
Temperature Stability

Stable under ambient conditions

Consistent performance 15-30°C
Batch Reproducibility

Variation: ±0.3% between batches

Exceptional lot-to-lot consistency
Shelf Stability

3 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Handle with standard pharmaceutical safety precautions. Use appropriate personal protective equipment including safety goggles, gloves, and protective clothing. Avoid inhalation of powder and ensure adequate ventilation in work areas. Follow established pharmaceutical handling protocols.

Caution
Avoid Inhalation
Wear Gloves

Storage & Handling

Store in original containers in a cool, dry place protected from light and moisture. Keep containers tightly closed and maintain pharmaceutical storage conditions. Use appropriate handling equipment and ensure controlled environment.

Store at 15-30°C
Protect from light
Protect from moisture
Keep containers tightly closed

Chemical Mechanisms & Reaction Pathways

Clascoterone exhibits anti-androgenic properties through selective androgen receptor antagonism, enabling predictable therapeutic response with well-characterized pharmacokinetic and pharmacodynamic profiles.

Mechanism of Action

Selective androgen receptor antagonism

Topical anti-androgenic activity
Metabolic Pathway

Rapid enzymatic hydrolysis to cortexolone

Minimized systemic exposure
Pharmacokinetics

Topical application with minimal absorption

Localized dermatological action
Elimination

Rapid metabolic clearance post-absorption

Reduced systemic side effects

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 Clascoterone 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 Clascoterone 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 Clascoterone 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 Clascoterone effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Formulations
Bioavailability: Topical application Half-life: Rapid local metabolism Stability: 3+ years ambient storage
Clinical Applications
Efficacy: 70-85% acne improvement Safety: Minimal systemic exposure Dosage: 1% cream 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