Fexofenadine Hydrochloride API
Pharmaceutical Premium
Pharmaceutical API

Fexofenadine Hydrochloride

High-purity pharmaceutical grade Fexofenadine Hydrochloride API manufactured to meet stringent USP/EP specifications for antihistamine and allergy treatment formulations. Our pharmaceutical grade API delivers exceptional purity and consistency for critical drug manufacturing applications.

  • USP/EP Grade Quality Standards
  • High Purity ≥99.0% (HPLC)
  • Comprehensive Analytical Documentation
  • Regulatory Compliance Support
  • cGMP Manufacturing Standards
  • Pharmaceutical Grade Packaging
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Technical Specifications

Chemical Formula: C32H39NO4·HCl
CAS Number: 153439-40-8
Molecular Weight: 538.12 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

Antihistamine Drug Manufacturing
Allergy Treatment Formulations
H1 Receptor Antagonist Products
API Synthesis & Development
Allergy Research Applications
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 Fexofenadine Hydrochloride grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse antihistamine and allergy treatment 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: Antihistamine formulations

Quality Standards

DRAVYOM's pharmaceutical grade Fexofenadine Hydrochloride 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 Fexofenadine Hydrochloride exhibits exceptional chemical properties essential for antihistamine therapy applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Sparingly soluble
LogP (octanol/water): 1.87
pKa: 4.25
Molecular Weight: 538.13 g/mol
Physical Properties
Appearance: White to off-white crystalline powder
Melting Point: 195-197°C
Bulk Density: 0.4-0.6 g/mL
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Bioavailability: 33% (oral)
Protein Binding: 60-70%
Half-life: 14.4 hours
Mechanism: H1 receptor antagonist
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤0.5% total
Water Content: ≤1.0% (Karl Fischer)
Residue on Ignition: ≤0.2%
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 Fexofenadine Hydrochloride superiority in antihistamine applications with exceptional H1 receptor antagonism, allergy symptom control, and reproducibility across diverse therapeutic protocols.

H1 Receptor Selectivity

High selectivity for H1 receptors

Non-sedating properties
Allergy Control

Effective symptom management

Seasonal and perennial allergies
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 195-197°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.1% between batches

Consistent therapeutic efficacy
CNS Penetration

Minimal CNS penetration

Reduced sedative effects

Safety Information

Pharmaceutical ingredient requiring professional handling protocols. Well-established safety profile for antihistamine therapy applications. Handle with appropriate pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring for drug interactions and renal function during therapeutic use.

Pharmaceutical Grade
Professional Use
Monitor renal 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

Fexofenadine Hydrochloride exhibits selective H1 receptor antagonist properties through competitive histamine binding, providing non-sedating antihistamine effects for allergic rhinitis, urticaria, and allergic skin conditions.

H1 Receptor Antagonism

Selective histamine H1 receptor competitive inhibition

Blocks allergic response cascade
Non-Sedating Profile

Minimal central nervous system penetration

Reduced sedation and drowsiness
Long-Acting Duration

Extended antihistamine activity up to 24 hours

Once-daily dosing convenience
Anti-inflammatory Effects

Reduces inflammation and allergic symptoms

Comprehensive allergy relief

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures antihistamine pharmaceutical manufacturing access with complete documentation packages supporting international standards and allergy medication development.

USP Standards

United States Pharmacopeia antihistamine drug specifications

EP Monograph

European Pharmacopoeia specifications for H1 receptor antagonists

Antihistamine GMP

Specialized GMP for antihistamine drug manufacturing

ICH Guidelines

International antihistamine drug development regulatory compliance

Antihistamine DMF

Drug Master File for antihistamine applications

Safety Documentation

Comprehensive antihistamine safety and pharmacovigilance documentation

Technical Support & Value-Added Services

DRAVYOM's antihistamine pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Fexofenadine Hydrochloride allergy medication applications.

Antihistamine Formulation
  • H1 receptor antagonist formulation optimization
  • Tablet and capsule development
  • Bioavailability enhancement
  • Custom antihistamine development
Analytical Services
  • API purity and potency analysis
  • Antihistamine impurity profiling
  • Stability testing protocols
  • Method validation support
Regulatory Support
  • Antihistamine regulatory filing
  • DMF preparation and maintenance
  • International compliance guidance
  • Antihistamine pharmacovigilance
Supply Solutions
  • Antihistamine pharmaceutical supply chain
  • Custom packaging solutions
  • Global distribution network
  • Emergency antihistamine supply

Environmental Impact & Sustainability

Our Fexofenadine Hydrochloride 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 Fexofenadine Hydrochloride quality and antihistamine 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 antihistamine 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 antihistamine data demonstrating Fexofenadine Hydrochloride effectiveness in allergy management with quantified performance metrics and clinical validation data.

Antihistamine Formulations
Bioavailability: 33% oral bioavailability Stability: 3-year shelf life validated Compatibility: Excellent with tablet excipients
Therapeutic Applications
Allergic Rhinitis: Proven seasonal and perennial allergy relief Urticaria: Effective chronic and acute hives treatment Safety: Non-sedating antihistamine profile
Manufacturing Performance
Yield: 95% pharmaceutical grade recovery Purity: >99.5% pharmaceutical specification Consistency: 99.8% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Antihistamine Excellence

Superior pharmaceutical grade with proven H1 receptor selectivity and regulatory compliance

Reliable Supply

Guaranteed antihistamine supply with strategic inventory management and specialized production

Allergy Medicine Expertise

Dedicated allergy medication development team with specialized antihistamine formulation support

Regulatory Compliance

Complete antihistamine documentation with DMF support and international compliance

Global Standards

International pharmaceutical compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative antihistamine relationships with specialized development services