Minoxidil USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Minoxidil USP/EP

High-purity pharmaceutical grade Minoxidil manufactured under stringent cGMP conditions. This vasodilator API is essential for hair growth treatment, particularly in androgenetic alopecia and male pattern baldness, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Vasodilator for Hair Growth
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C9H15N5O
CAS Number: 38304-91-5
EINECS Number: 253-874-2
Molecular Weight: 209.25 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 248-250°C
pH (1% solution): Not applicable (poorly soluble)
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤2.0% (total impurities)
Storage Conditions: Store below 25°C, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 25kg drums, 100kg containers

Applications

Androgenetic Alopecia
Hair Growth Treatment
Vasodilator Activity
Male Pattern Baldness
Dermatological Research
Hospital Dermatology
Pharmaceutical Manufacturing
Topical Formulations
Hair Loss Research
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Minoxidil grades tailored for specific dermatological pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse hair growth treatment 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: 248-250°C Related Substances: ≤2.0% Application: EU regulatory submissions
Dermatological Research Grade
Purity: ≥99.5% (HPLC) Enhanced vasodilator activity Low endotoxin levels Application: Hair growth research
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Minoxidil 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 Minoxidil exhibits exceptional chemical properties essential for dermatological applications. Its optimal molecular structure and superior vasodilatory characteristics ensure reliable performance in demanding hair growth treatment formulations.

Molecular Properties
Molecular Weight: 209.25 g/mol
Molecular Formula: C9H15N5O
LogP (Octanol/Water): 1.2
Solubility (Water): 2.0 mg/mL at 37°C
Physical Properties
Melting Point: 248-250°C
Appearance: White to off-white crystalline powder
Crystal Form: Polymorphic Form I
Bulk Density: 0.45-0.55 g/cm³
Pharmaceutical Properties
Bioavailability (Topical): 1.4-1.7%
Protein Binding: Minimal
Half-life: 4.2 hours
Mechanism: Vasodilation, hair follicle stimulation
Quality Specifications
Purity (HPLC): ≥99.0%
Loss on Drying: ≤0.5%
Related Substances: ≤2.0%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-25°C
Light Sensitivity: Store in light-resistant containers
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate Minoxidil superiority in dermatological applications with exceptional vasodilatory activity, hair follicle stimulation, and therapeutic efficacy across diverse hair growth treatment protocols.

Hair Growth Stimulation

Promotes anagen phase extension

Enhanced follicular activity
Vasodilatory Activity

Potent smooth muscle relaxation

Improved scalp circulation
Topical Absorption

Optimal dermal penetration

Effective scalp delivery
Formulation Stability

Stable in topical formulations

Compatible with excipients
Clinical Efficacy

Proven hair regrowth in clinical trials

FDA-approved performance
Sustained Release

Extended follicular residence time

Prolonged therapeutic effect

Safety Information

Well-tolerated pharmaceutical active ingredient with established safety profile. Avoid contact with eyes and mucous membranes. Use appropriate personal protective equipment during manufacturing and handle according to good pharmaceutical practices.

Avoid Eye Contact
Good Hygiene Required
Well-Tolerated API

Storage & Handling

Store in tightly closed, light-resistant containers in a cool, dry place away from direct sunlight. Maintain controlled room temperature storage and ensure protection from moisture to preserve pharmaceutical quality and potency.

Controlled room temperature (15-25°C)
Protect from light
Light-resistant containers
Store in dry conditions

Chemical Mechanisms & Reaction Pathways

Minoxidil exhibits potent vasodilating activity through potassium channel activation and nitric oxide pathways, enabling precise dermatological applications with enhanced follicular circulation and growth stimulation properties.

K+ Channel Activation

Opens ATP-sensitive potassium channels in smooth muscle

Promotes vasodilation and increased blood flow
Follicular Circulation

Enhances microcirculation around hair follicles

Improves nutrient delivery and hair growth
Growth Factor Stimulation

Activates growth factors and prolongs anagen phase

Extends active hair growth period
Prostaglandin Synthesis

Stimulates prostaglandin E2 production

Anti-inflammatory and growth-promoting effects

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international standards and dermatological pharmaceutical regulatory requirements.

USP Specifications

United States Pharmacopeia dermatological pharmaceutical grade standards compliance

EP Standards

European Pharmacopoeia specifications for dermatological pharmaceutical manufacturing

cGMP Manufacturing

Current Good Manufacturing Practice certified dermatological API production

ICH Guidelines

International Conference on Harmonisation dermatological quality standards

DMF Support

Drug Master File documentation for dermatological regulatory submissions

Safety Documentation

Complete dermatological safety and handling documentation package

Technical Support & Value-Added Services

DRAVYOM's dermatological pharmaceutical development team provides comprehensive formulation support, topical delivery guidance, and regulatory support to optimize Minoxidil performance in your dermatological pharmaceutical applications.

Formulation Development
  • Topical solution optimization
  • Foam formulation design
  • Penetration enhancement strategies
  • Stability enhancement guidance
Analytical Services
  • Certificate of Analysis verification
  • Dermatological API purity profiling
  • Stability method validation
  • Permeation testing programs
Technical Support
  • Dermatological API troubleshooting
  • cGMP compliance for topical manufacturing
  • Penetration enhancement consultation
  • Regulatory documentation support
Supply Solutions
  • Specialized dermatological packaging
  • Light-protected logistics
  • Emergency dermatological supply
  • Global pharmaceutical distribution

Environmental Impact & Sustainability

Our Minoxidil production emphasizes environmental responsibility through sustainable dermatological pharmaceutical manufacturing practices, waste minimization, and comprehensive environmental impact management for topical API operations.

Waste Minimization

Optimized synthesis with minimal dermatological pharmaceutical waste generation

Water Treatment

Advanced pharmaceutical wastewater treatment and recycling systems

Green Chemistry

Environmentally conscious dermatological API synthesis with emission controls

Safe Disposal

Comprehensive guidance for dermatological pharmaceutical waste management

ISO 14001

Environmental management system certified pharmaceutical production

Carbon Footprint

Reduced carbon footprint through dermatological API process optimization

Manufacturing Excellence & Quality Control

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

Production Process

Advanced synthesis and purification in controlled dermatological environment

Multi-stage crystallization for dermatological pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing including vasodilator activity analysis

HPLC verification and bioactivity analysis
Quality Systems

ISO 9001:2015 quality management with dermatological pharmaceutical accreditation

Specialized dermatological API quality systems
Packaging Control

Specialized light-resistant containers with moisture protection

Light and moisture protection systems

Market Applications & Performance Data

Comprehensive dermatological pharmaceutical development data demonstrating Minoxidil effectiveness across diverse therapeutic applications with quantified performance metrics and hair growth development validations.

Dermatological Manufacturing
Bioavailability: Enhanced topical penetration Stability: Light-sensitive API Purity: >99.0% dermatological grade
Clinical Applications
Efficacy: Proven androgenic alopecia treatment Safety: Established dermatological safety profile Regulatory: Dermatological approvals worldwide
Manufacturing Capabilities
Capacity: Controlled dermatological production batches Consistency: <0.5% batch-to-batch variation Compliance: 100% dermatological cGMP adherence

DRAVYOM Competitive Advantages

Dermatological Expertise

Specialized dermatological manufacturing with ultra-low impurities and exceptional vasodilator pharmaceutical performance

Reliable Supply

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

Topical Expertise

Dedicated dermatological pharmaceutical development team with topical formulation expertise

Quality Assurance

Comprehensive certificates with complete analytical data and dermatological handling documentation

Global Standards

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

Partnership Approach

Collaborative relationships with dermatological pharmaceutical companies and custom topical API development