Benzalkonium Chloride
Pharmaceutical Premium
Pharmaceutical Excipient

Benzalkonium Chloride

High-purity pharmaceutical Benzalkonium Chloride manufactured to meet stringent USP and EP specifications for antiseptic and preservative applications. Our Benzalkonium Chloride provides excellent antimicrobial activity with broad-spectrum effectiveness for pharmaceutical and topical formulations.

  • USP/EP Pharmaceutical Grade
  • Superior Antiseptic Properties
  • Excellent Antimicrobial Activity
  • Enhanced Stability
  • Consistent Quality
  • Ultra-Low Impurities
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Technical Specifications

Chemical Formula: C21H38ClN·nH2O
CAS Number: 8001-54-5
Molecular Weight: 354.00 g/mol (avg)
Purity (Assay): ≥95.0% (titration)
Physical State: White to pale yellow viscous liquid
Water Content (Karl Fischer): ≤2.0%
pH (1% solution): 6.0 - 8.0
Heavy Metals (as Pb): ≤10 ppm
Antimicrobial Activity: Broad-spectrum bactericidal
Storage Conditions: Store in cool, dry place (15-30°C)
Packaging Options: 1L, 5L pharmaceutical containers

Applications

Antiseptic Formulations
Ophthalmic Preparations
Injectable Preservative
Pharmaceutical Preservative
Topical Antiseptic Applications
Pharmaceutical Research
Drug Product Manufacturing
Quality Control Testing
Regulatory Compliance
Antimicrobial Efficacy Testing
Bioanalytical Method Development
Reference Standard Applications

Industry-Specific Grades

DRAVYOM offers specialized Benzalkonium Chloride grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse antiseptic and preservative applications.

USP Grade (Pharmaceutical)
Purity: ≥95.0% (titration) Water Content: ≤2.0% Heavy Metals: ≤10 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥95.0% (pharmaceutical) pH: 6.0 - 8.0 Antimicrobial Activity: Verified Application: European market compliance
Research Grade
Purity: ≥90.0% (analytical) Water Content: ≤3.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥98.0% (pharmaceutical) Endotoxins: ≤0.5 EU/mL Microbial Limits: Compliant Application: Injectable preservatives

Quality Standards

DRAVYOM's pharmaceutical grade Benzalkonium Chloride 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
≥95.0% Pharmaceutical Purity
Advanced Analytical Testing
Comprehensive Impurity Control
Batch-to-Batch Consistency
Complete Documentation Package
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Benzalkonium Chloride exhibits exceptional chemical properties essential for antimicrobial applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Freely soluble
LogP (octanol/water): 2.9
pKa: N/A (quaternary ammonium)
UV λmax: 262 nm
Physical Properties
Melting Point: 134-136°C
Bulk Density: 0.3-0.5 g/mL
Crystalline Form: White to yellowish-white powder
Hygroscopicity: Hygroscopic
Antimicrobial Performance
MIC (E. coli): 0.5-2.0 μg/mL
MIC (S. aureus): 0.5-1.0 μg/mL
Kill Time: ≤30 seconds
Spectrum: Broad-spectrum antimicrobial
Purity Specifications
Assay (HPLC): ≥95.0%
Related Substances: ≤5.0% total
Water Content: ≤5.0% (Karl Fischer)
Residue on Ignition: ≤0.1%
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable 15-30°C
Container Compatibility: HDPE, glass containers

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Benzalkonium Chloride superiority in antimicrobial applications with exceptional efficacy, stability, and reproducibility across diverse pharmaceutical formulations and preservation protocols.

Antimicrobial Efficacy

Log reduction: >3 log in 30 seconds

Rapid broad-spectrum antimicrobial action
Solution Stability

Stable in aqueous solution for 24 months

Long-term pharmaceutical stability
Concentration Efficacy

Effective at 0.01-0.02% concentration

Low-dose antimicrobial preservation
Temperature Stability

Stable under ambient conditions

Consistent performance 15-30°C
Batch Reproducibility

Variation: ±2.0% between batches

Consistent antimicrobial potency
Shelf Stability

3 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Antimicrobial compound requiring careful handling. Use appropriate personal protective equipment including safety goggles, gloves, and protective clothing. Avoid eye contact and inhalation of powder. Ensure adequate ventilation and follow pharmaceutical handling protocols.

Irritant
Eye Irritant
Wear Gloves

Storage & Handling

Store in original containers in a cool, dry place protected from light and moisture. Keep containers tightly closed and maintain pharmaceutical storage conditions. Handle with care to prevent contamination.

Store at 15-30°C
Protect from light
Protect from moisture
Keep containers tightly closed

Chemical Mechanisms & Reaction Pathways

Benzalkonium Chloride exhibits quaternary ammonium antiseptic properties through cationic surfactant activity, enabling precise antimicrobial applications with predictable membrane disruption pathways and quantitative biocidal enhancement mechanisms.

Membrane Disruption

Cationic binding to negatively charged bacterial membranes

Quantitative cell wall permeabilization
Protein Denaturation

Alteration of microbial protein structure and function

Essential for broad-spectrum antimicrobial activity
Enzyme Inhibition

Disruption of critical metabolic enzyme systems

Enables rapid microbial inactivation
Surface Activity

Reduction of surface tension for enhanced penetration

Predictable antimicrobial efficacy

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia pharmaceutical standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical analysis

ICH Guidelines

International Conference on Harmonization pharmaceutical compliance

FDA Registration

United States Food and Drug Administration compliance

Method Validation

Supported analytical method validation documentation

SDS Documentation

Multi-language Safety Data Sheets (16 sections, GHS compliant)

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, stability testing assistance, and regulatory services to optimize pharmaceutical grade Benzalkonium Chloride performance in your specific therapeutic applications.

Formulation Development
  • Pharmaceutical formulation optimization support
  • Stability testing guidance
  • Bioavailability and bioequivalence validation
  • Custom pharmaceutical procedures
Analytical Services
  • Certificate of Analysis verification
  • Custom purity analysis
  • Impurity profiling and identification
  • Method validation support
Technical Support
  • Pharmaceutical troubleshooting consultation
  • Storage and handling guidance
  • Safety training and protocols
  • Manufacturing best practices
Supply Solutions
  • Consistent batch scheduling
  • Emergency supply arrangements
  • Custom packaging options
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical grade Benzalkonium Chloride production emphasizes environmental responsibility through sustainable manufacturing practices, waste minimization, and comprehensive environmental impact management for pharmaceutical operations.

Waste Minimization

Optimized production with minimal waste generation

Water Treatment

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive guidance for pharmaceutical waste management

ISO 14001

Environmental management system certified production

Container Recycling

Pharmaceutical container return and recycling programs

Manufacturing Excellence & Quality Control

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

Production Process

Advanced synthesis and purification in controlled cGMP environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing protocol including purity, impurities, and stability

HPLC verification and spectroscopic analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical manufacturing accreditation

Continuous improvement and process validation
Packaging Control

Pharmaceutical containers with controlled atmosphere packaging

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating pharmaceutical grade Benzalkonium Chloride effectiveness across diverse therapeutic applications with quantified performance metrics and clinical study validations.

Pharmaceutical Manufacturing
Purity: >95% pharmaceutical grade Antimicrobial Activity: 99.9% efficacy Stability: 36+ months under controlled conditions
Research Institutions
Clinical Studies: 800+ published research applications Reproducibility: >98% batch-to-batch consistency Innovation: Custom grade development
Generic Manufacturing
Regulatory Success: 100% FDA approval support Cost Efficiency: 25% reduction in manufacturing costs Quality Assurance: Zero batch failures

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmaceutical specifications with ultra-low impurities and exceptional therapeutic performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production scheduling

Pharmaceutical Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Quality Assurance

Traceable certificates with comprehensive analytical data and regulatory compliance support

Global Standards

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

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services

Pharmaceutical Excellence Demands Pure Excipients

Get pharmaceutical grade Benzalkonium Chloride for antiseptic applications, explore bulk quantities, or discuss formulation optimization with our pharmaceutical specialists.

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