Finasteride USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Finasteride USP/EP

High-purity pharmaceutical grade Finasteride manufactured under stringent cGMP conditions. This 5α-reductase inhibitor API is essential for treating male pattern baldness and benign prostatic hyperplasia, providing reliable quality and regulatory compliance for hair loss prevention and prostate health.

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

Chemical Formula: C23H36N2O2
CAS Number: 98319-26-7
Molecular Weight: 372.55 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 (15-25°C)
Packaging Options: 1kg, 5kg pharmaceutical containers

Applications

Hair Loss Treatment Manufacturing
Male Pattern Baldness Formulations
5α-Reductase Inhibitor Products
API Synthesis & Development
Urological 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 Finasteride grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse hair loss treatment and prostate health 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: Hair loss formulations

Quality Standards

DRAVYOM's pharmaceutical grade Finasteride 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 Finasteride exhibits exceptional chemical properties essential for 5α-reductase inhibition 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): 3.03
pKa: No ionizable groups
Molecular Weight: 372.55 g/mol
Physical Properties
Appearance: White crystalline powder
Melting Point: 252-254°C
Bulk Density: 0.4-0.6 g/mL
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Bioavailability: 80% (oral)
Protein Binding: 90%
Half-life: 5-6 hours
Mechanism: 5α-reductase inhibitor
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤1.0% total
Water Content: ≤1.0% (Karl Fischer)
Residue on Ignition: ≤0.2%
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store below 25°C
pH Stability: Stable across pH range

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Finasteride superiority in hair loss prevention applications with exceptional 5α-reductase inhibition, DHT suppression, and reproducibility across diverse therapeutic protocols.

5α-Reductase Inhibition

Potent Type II 5α-reductase inhibition

90% DHT suppression
Hair Loss Prevention

Effective hair loss prevention

Promotes hair regrowth
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 5 years
Thermal Stability

Melting point: 252-254°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.1% between batches

Consistent therapeutic efficacy
Oral Bioavailability

High oral bioavailability (80%)

Once-daily dosing

Safety Information

Pharmaceutical ingredient requiring professional handling protocols. Well-established safety profile for hair loss treatment applications. Handle with appropriate pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring for sexual side effects and mood changes during therapeutic use.

Pharmaceutical Grade
Professional Use
Monitor for side effects

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

Finasteride exhibits selective 5α-reductase type II inhibition through competitive enzyme binding, reducing dihydrotestosterone (DHT) production for effective treatment of benign prostatic hyperplasia and androgenetic alopecia.

5α-Reductase Inhibition

Selective type II 5α-reductase enzyme inhibition

Blocks DHT conversion pathway
DHT Reduction

Significant reduction in dihydrotestosterone levels

Up to 70% DHT suppression
Prostate Benefits

Reduces prostate size and improves urinary flow

BPH symptom improvement
Hair Growth Promotion

Prevents hair follicle miniaturization

Reverses male pattern baldness

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures urological pharmaceutical manufacturing access with complete documentation packages supporting international standards and hormone-based therapy 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 Finasteride hormone therapy applications.

Urological Formulation
  • 5α-reductase inhibitor formulation optimization
  • Tablet development for BPH and alopecia
  • Bioavailability enhancement
  • 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
  • Urological pharmacovigilance
Supply Solutions
  • Urological pharmaceutical supply chain
  • Custom packaging solutions
  • Global distribution network
  • Emergency urological supply

Environmental Impact & Sustainability

Our Finasteride 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 Finasteride quality and urological therapeutic performance.

Pharmaceutical GMP

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 pharmaceutical compliance

Continuous improvement and pharmaceutical validation
Pharmaceutical Packaging

Pharmaceutical-grade containers with moisture protection

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive urological data demonstrating Finasteride effectiveness in hormone-related conditions with quantified performance metrics and clinical validation data.

Urological Formulations
Bioavailability: 80% oral bioavailability Stability: 5-year shelf life validated Compatibility: Excellent with tablet excipients
Therapeutic Applications
BPH: Proven benign prostatic hyperplasia treatment Alopecia: Effective androgenetic alopecia treatment Safety: Well-tolerated 5α-reductase inhibitor
Manufacturing Performance
Yield: 94% pharmaceutical grade recovery Purity: >99.0% pharmaceutical specification Consistency: 99.7% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Urological Excellence

Superior pharmaceutical grade with proven 5α-reductase inhibition and regulatory compliance

Reliable Supply

Guaranteed urological supply with strategic inventory management and specialized production

Hormone Therapy Expertise

Dedicated hormone therapy development team with specialized urological formulation support

Regulatory Compliance

Complete urological documentation with DMF support and international compliance

Global Standards

International pharmaceutical compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative urological relationships with specialized development services