Piroctone Olamine USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Piroctone Olamine USP/EP

High-purity pharmaceutical grade Piroctone Olamine manufactured under stringent cGMP conditions. This antifungal API is essential for anti-dandruff applications, particularly in seborrheic dermatitis and scalp treatment, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Antifungal for Anti-dandruff Treatment
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C12H18N2O2·C2H7NO
CAS Number: 68890-66-4
EINECS Number: 272-574-2
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white crystalline powder
Molecular Weight: 283.37 g/mol
Melting Point: 125-130°C
pH (1% solution): 7.0-9.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Soluble in water and ethanol
Storage Conditions: Store below 25°C, dry place
Shelf Life: 3 years from manufacture date
Packaging Options: 1kg, 5kg, 25kg drums

Applications

Anti-dandruff Shampoos
Scalp Treatment Products
Antifungal Applications
Seborrheic Dermatitis
Topical Formulations
Antimicrobial Preservative
Fungal Infection Treatment
Hair Care Products
Dermatological Research
Clinical Trials
Cosmetic Formulations
Personal Care Products

Industry-Specific Grades

DRAVYOM offers specialized Piroctone Olamine grades tailored for specific antifungal applications, ensuring optimal antimicrobial efficacy and regulatory compliance across diverse dermatological formulations.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% Related Substances: ≤1.0% Residual Solvents: EP limits Application: European market compliance
Cosmetic Grade
Purity: ≥98.0% Skin Compatibility: Tested Stability: Enhanced Application: Personal care products
Antifungal Grade
Purity: ≥99.5% Antimicrobial Activity: Verified pH Stability: Optimized Application: Anti-dandruff products

Quality Standards

DRAVYOM's Piroctone Olamine is manufactured under stringent cGMP protocols, meeting international dermatological standards including USP, EP, and FDA guidelines for antifungal applications.

cGMP Manufacturing Standards
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
Antifungal Activity Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Controlled Storage & Shipping

Advanced Chemical Properties & Performance

Piroctone Olamine exhibits exceptional antifungal properties essential for dermatological applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding anti-dandruff and antifungal formulations.

Molecular Properties
Molecular Weight: 266.34 g/mol
LogP: 1.8
pKa: 9.2
Bioavailability: Topical application
Physical Properties
Melting Point: 155-160°C
Solubility (Water): 2.5 mg/mL
Crystalline Form: Stable olamine salt
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
MIC (C. albicans): 0.25 μg/mL
Antifungal Spectrum: Broad spectrum
Selectivity: Dermatophyte selective
Stability: Stable in formulations
Purity Specifications
Assay: ≥99.0%
Related Substances: ≤0.5%
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Room temperature stable
pH Stability: Stable pH 4-8

Performance Characteristics

Detailed performance metrics demonstrate Piroctone Olamine superiority in dermatological applications with exceptional antifungal activity, bioavailability, and reproducibility across diverse anti-dandruff formulations.

Antifungal Activity

MIC: 0.25 μg/mL vs C. albicans

Potent broad-spectrum activity
Bioavailability

Topical: Optimized penetration

Effective dermal delivery
Stability

Solid state: >3 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 15-40°C processing

Stable during formulation
Batch Reproducibility

Variation: ±0.5% between batches

Consistent lot-to-lot performance
Shelf Stability

3 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade dermatological API requiring careful handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for pharmaceutical APIs and ensure proper waste disposal procedures.

Pharmaceutical API
Avoid Skin Contact
Avoid Inhalation

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from light and moisture. Keep containers tightly closed and protect from direct sunlight. Use appropriate containment measures for pharmaceutical API handling.

Room temperature storage (15-25°C)
Protect from light
Original sealed containers
Pharmaceutical containment required

Chemical Mechanisms & Reaction Pathways

Piroctone olamine functions as a potent antifungal agent with selective activity against dermatophyte fungi and yeasts, providing effective antimicrobial protection through inhibition of fungal enzyme systems and cell membrane disruption.

Antifungal Mechanism

Selective inhibition of fungal enzyme systems

Disrupts fungal metabolism
Cell Membrane Action

Disruption of fungal cell membrane integrity

Prevents fungal growth and replication
Broad Spectrum Activity

Effective against dermatophytes, yeasts, and molds

Comprehensive antimicrobial coverage
Stability Profile

Chemical stability in pharmaceutical formulations

Maintains activity over extended periods

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical acceptance with complete documentation packages supporting international drug development and manufacturing requirements.

USP Specifications

United States Pharmacopeia pharmaceutical grade compliance

EP Standards

European Pharmacopoeia specifications and testing protocols

ICH Guidelines

International harmonized pharmaceutical development standards

Global Regulatory

Multi-regional pharmaceutical registration support

DMF Support

Drug Master File preparation and regulatory submission

GMP Compliance

Good Manufacturing Practice certified production

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory assistance to optimize Piroctone olamine performance in pharmaceutical applications.

Formulation Development
  • Topical formulation optimization
  • Anti-dandruff shampoo development
  • Stability enhancement strategies
  • Preservative system design
Analytical Services
  • Method validation and transfer
  • Antimicrobial efficacy testing
  • Stability testing programs
  • Antifungal activity assays
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Controlled storage packaging
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

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

Green Chemistry

Environmentally conscious synthesis with minimal waste

Water Management

Advanced wastewater treatment and recycling systems

Energy Efficiency

Optimized manufacturing processes with reduced energy consumption

Waste Reduction

Comprehensive waste minimization and disposal protocols

ISO 14001

Environmental management system certified production

Carbon Footprint

Reduced environmental impact through sustainable practices

Manufacturing Excellence & Quality Control

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

GMP Production

Good Manufacturing Practice certified facility with controlled environments

Pharmaceutical-grade production standards
Quality Testing

Comprehensive analytical testing including potency and purity

HPLC, LC-MS, and antifungal assays
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Controlled atmosphere packaging with moisture protection

Stability maintenance and protection systems

Market Applications & Performance Data

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

Pharmaceutical Manufacturing
Antifungal Activity: MIC 0.5-2 µg/mL Stability: 3+ years shelf life Purity: >99% pharmaceutical grade
Drug Development
Formulation Support: Anti-dandruff products Regulatory Success: Global approvals achieved Innovation: Topical antifungal formulations
Clinical Applications
Efficacy: Broad-spectrum antifungal activity Safety: Well-tolerated topical use Versatility: Dermatological applications

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with pharmaceutical-grade quality and performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production

Development Expertise

Dedicated pharmaceutical team provides formulation development and regulatory support

Quality Assurance

Comprehensive documentation with pharmaceutical-grade certificates and regulatory compliance

Global Standards

International compliance with USP, EP, and ICH guidelines for worldwide acceptance

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services