Posaconazole
Pharmaceutical Premium
Pharmaceutical API

Posaconazole

High-purity pharmaceutical grade Posaconazole manufactured to meet stringent USP/EP specifications for pharmaceutical formulations and research applications. Our pharmaceutical grade material delivers exceptional purity and consistency for critical pharmaceutical manufacturing.

  • USP/EP Grade Specifications
  • High Purity (≥99.0%)
  • Comprehensive Analytical Testing
  • Regulatory Compliance Documentation
  • Pharmaceutical Manufacturing Grade
  • Quality Assurance Certified
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Technical Specifications

Chemical Formula: C37H42F2N8O4
CAS Number: 171228-49-2
EINECS Number: Not applicable
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white crystalline powder
Molecular Weight: 700.77 g/mol
Melting Point: 168-172°C
pH (1% solution): 6.0-8.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Practically insoluble in water
Storage Conditions: Store at 2-8°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 1g, 5g, 25g vials

Applications

Antifungal Agent
Invasive Fungal Infections
Oral Capsule Formulations
Injectable Solutions
Tablet Preparations
Aspergillosis Treatment
Prophylactic Therapy
Immunocompromised Patients
Antifungal Research
Clinical Trials
Drug Development
Regulatory Studies

Industry-Specific Grades

DRAVYOM offers specialized Posaconazole grades tailored for specific pharmaceutical applications, ensuring optimal antifungal efficacy and regulatory compliance across diverse formulation requirements.

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
Research Grade
Purity: ≥98.0% Activity: Verified Stability: Enhanced Application: Antifungal research
Injectable Grade
Purity: ≥99.5% Endotoxins: <0.25 EU/mg Sterility: Assured Application: Parenteral formulations

Quality Standards

DRAVYOM's Posaconazole is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and FDA guidelines for antifungal therapy 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
Cold Chain Storage & Shipping

Advanced Chemical Properties & Performance

Pharmaceutical Grade Posaconazole exhibits exceptional chemical properties essential for antifungal applications. Its potent triazole structure and superior stability characteristics ensure reliable performance in demanding invasive fungal infection treatment formulations.

Molecular Properties
Molecular Weight: 700.78 g/mol
Molecular Formula: C37H42F2N8O4
LogP (Octanol/Water): 5.2
pKa: 3.6, 4.6
Physical Properties
Melting Point: 167-172°C
Appearance: White to off-white crystalline powder
Solubility (Water): Practically insoluble
Bulk Density: 0.40-0.50 g/cm³
Pharmaceutical Properties
Bioavailability: Variable (food-dependent)
Protein Binding: >98%
Half-life: 35 hours
Mechanism: CYP51A1 inhibition
Quality Specifications
Purity (HPLC): ≥99.0%
Water Content: ≤0.5%
Related Substances: ≤1.0%
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 Posaconazole superiority in antifungal applications with exceptional broad-spectrum activity, invasive mycoses treatment, and therapeutic efficacy across diverse fungal infection protocols.

Broad-spectrum Activity

Potent activity against yeasts and molds

Aspergillus and Candida coverage
CYP51A1 Inhibition

Selective fungal lanosterol 14α-demethylase inhibition

Ergosterol biosynthesis disruption
Invasive Mycoses

Superior efficacy in invasive aspergillosis

Life-threatening fungal infections
Extended Half-life

35-hour elimination half-life

Convenient dosing intervals
Clinical Efficacy

FDA-approved for invasive fungal infections

Proven antifungal benefits
Prophylactic Use

Effective for preventing invasive fungal infections

Immunocompromised patient protection

Safety Information

Pharmaceutical active ingredient requiring careful handling protocols. Handle in controlled environments with appropriate ventilation systems. Use proper personal protective equipment and follow established safety protocols for antifungal compounds.

Active Pharmaceutical Ingredient
Controlled Handling Required
Standard PPE Required

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 and humidity to preserve pharmaceutical quality and antifungal potency.

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

Chemical Mechanisms & Reaction Pathways

Posaconazole functions as a triazole antifungal agent with broad-spectrum activity against invasive mycoses, providing effective treatment through ergosterol biosynthesis inhibition and fungal cell membrane disruption.

CYP51 Inhibition

Selective inhibition of fungal 14α-demethylase

Blocks ergosterol synthesis pathway
Membrane Disruption

Destabilization of fungal cell membrane integrity

Compromises cellular function
Broad Spectrum

Activity against yeasts, molds, and endemic fungi

Wide therapeutic coverage
High Affinity

Strong binding to fungal CYP51 enzyme

Potent antifungal activity

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 Posaconazole performance in pharmaceutical applications.

Formulation Development
  • Suspension formulation optimization
  • Bioavailability enhancement
  • Tablet formulation strategies
  • IV formulation development
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • 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
  • Light-protected packaging
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

Our Posaconazole 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 Posaconazole 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

Light-protected packaging with moisture control

Photostability and stability assurance

Market Applications & Performance Data

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

Pharmaceutical Manufacturing
Bioavailability: >90% with food Half-life: 25-31 hours duration Purity: >99.5% pharmaceutical grade
Drug Development
Formulation Support: Multiple dosage forms Regulatory Success: Global approvals achieved Innovation: Triazole antifungal therapy
Clinical Applications
Efficacy: Broad-spectrum antifungal activity Safety: Established antifungal profile Specialization: Invasive fungal infections

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