Dutasteride USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Dutasteride USP/EP

High-purity pharmaceutical grade Dutasteride manufactured under stringent cGMP conditions. This dual 5α-reductase inhibitor API is essential for benign prostatic hyperplasia treatment, providing reliable quality and regulatory compliance for prostate health management.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Dual 5α-reductase Inhibitor for BPH
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C27H30F6N2O2
CAS Number: 164656-23-9
Molecular Weight: 528.53 g/mol
Purity (HPLC): ≥99.0% (pharmaceutical grade)
Physical State: White to pale yellow 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: 100g, 500g pharmaceutical containers

Applications

Urological Drug Manufacturing
5α-Reductase Inhibitor
Oral Pharmaceutical Products
API Synthesis & Development
BPH Treatment 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 Dutasteride grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse urological 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: Urological formulations

Quality Standards

DRAVYOM's pharmaceutical grade Dutasteride 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 Dutasteride exhibits exceptional chemical properties essential for urological 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): 6.5
pKa: 14.8
Molecular Weight: 528.53 g/mol
Physical Properties
Appearance: White to off-white crystalline powder
Melting Point: 242-244°C
Bulk Density: 0.4-0.6 g/mL
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Bioavailability: 60% (oral)
Protein Binding: 99%
Half-life: 5 weeks
Mechanism: 5α-reductase inhibitor (dual type 1 and 2)
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 Dutasteride superiority in urological applications with exceptional dual 5α-reductase inhibition, prostate reduction, and reproducibility across diverse therapeutic protocols.

Dual Inhibition

Inhibits both type 1 and type 2 5α-reductase

Superior DHT suppression
Long Half-life

5-week half-life for sustained action

Continuous therapeutic effect
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 242-244°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.2% between batches

Consistent therapeutic efficacy
Lipophilic Profile

High lipophilicity for tissue penetration

Excellent prostate tissue distribution

Safety Information

Prescription pharmaceutical ingredient requiring professional handling. Well-established safety profile for urological therapy. Handle with pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring for hepatic function and sexual side effects during therapeutic use.

Prescription Only
Professional Use
Monitor liver function

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

Dutasteride exhibits 5α-reductase inhibition properties through dual enzyme inhibition, blocking conversion of testosterone to dihydrotestosterone for benign prostatic hyperplasia and androgenic alopecia treatment.

Dual Inhibition

Blocks both 5α-reductase type I and type II enzymes

Comprehensive DHT suppression
DHT Reduction

Prevents testosterone conversion to dihydrotestosterone

Reduces androgenic effects
Prostate Effect

Reduces prostate size through androgen suppression

Improves urinary flow
Hair Preservation

Prevents DHT-mediated hair follicle miniaturization

Maintains hair density

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures urological pharmaceutical manufacturing access with complete documentation packages supporting international standards and 5α-reductase inhibitor development.

USP Standards

United States Pharmacopeia urological drug specifications

EP Monograph

European Pharmacopoeia specifications for 5α-reductase inhibitors

Urological GMP

Specialized GMP for urological drug manufacturing

ICH Guidelines

International urological drug development regulatory compliance

Urological DMF

Drug Master File for urological applications

Safety Documentation

Comprehensive urological safety and pharmacovigilance documentation

Technical Support & Value-Added Services

DRAVYOM's urological pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Dutasteride urological applications.

Urological Formulation
  • Urological formulation optimization
  • Bioavailability enhancement
  • Soft gelatin capsule development
  • Custom urological development
Analytical Services
  • API purity and potency analysis
  • Urological impurity profiling
  • Stability testing protocols
  • Method validation support
Regulatory Support
  • Urological regulatory filing
  • DMF preparation and maintenance
  • International compliance guidance
  • Pharmacovigilance support
Supply Solutions
  • Pharmaceutical supply chain
  • Custom packaging solutions
  • Global distribution network
  • Emergency supply arrangements

Environmental Impact & Sustainability

Our Dutasteride 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 Dutasteride quality and urological therapeutic performance.

Controlled Production

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 urological analysis
Quality Systems

ISO 9001:2015 quality management with urological compliance

Continuous improvement and urological validation
Pharmaceutical Packaging

Pharmaceutical-grade containers with moisture protection

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive urological data demonstrating Dutasteride effectiveness in BPH and androgenic alopecia treatment with quantified performance metrics and clinical validation data.

Urological Formulations
Bioavailability: 60% oral bioavailability Stability: 3-year shelf life validated Compatibility: Excellent with soft gelatin capsules
Therapeutic Applications
BPH: Proven prostate size reduction Alopecia: Effective hair loss prevention Safety: Well-tolerated urological profile
Manufacturing Performance
Yield: 96% pharmaceutical grade recovery Purity: >99.5% urological specification Consistency: 99.8% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Urological Excellence

Superior urological pharmaceutical grade with proven therapeutic performance and regulatory compliance

Reliable Supply

Guaranteed availability with strategic inventory management and urological production scheduling

Formulation Expertise

Dedicated urological pharmaceutical development team with specialized formulation support

Regulatory Compliance

Complete urological documentation with DMF support and international compliance

Global Standards

International urological compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative urological relationships with specialized development services