Potassium Sorbate
Pharmaceutical Premium
Pharmaceutical Excipient

Potassium Sorbate

High-purity pharmaceutical Potassium Sorbate manufactured to meet stringent USP and EP specifications for preservative applications. Our Potassium Sorbate provides excellent antimicrobial activity with broad-spectrum effectiveness for various pharmaceutical formulations.

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

Chemical Formula: C6H7KO2
CAS Number: 24634-61-5
EINECS Number: 246-376-1
Grade: USP/EP Pharmaceutical Grade
Physical State: White crystalline powder
Molecular Weight: 150.22 g/mol
Assay (as dried basis): 99.0-101.0%
pH (1% solution): 7.0-8.5
Loss on Drying: ≤1.0%
Residue on Ignition: ≤37.0%
Heavy Metals: ≤10 ppm
Solubility: Freely soluble in water
Storage Conditions: Store below 25°C, dry place
Shelf Life: 3 years from manufacture date
Packaging Options: 1kg, 5kg, 25kg bags

Applications

Antimicrobial Preservative
Ophthalmic Solutions
Liquid Formulations
Topical Preparations
Injectable Solutions
Tablet Formulations
Capsule Preparations
Parenteral Formulations
Antifungal Preservative
Oral Liquid Medicines
Cosmeceutical Products
Pharmaceutical Research

Industry-Specific Grades

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

USP Grade (United States Pharmacopoeia)
Assay: 99.0-101.0% Water Content: ≤1.0% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
pH Range: 7.0-8.5 Residue on Ignition: ≤37.0% Antimicrobial Activity: Verified Application: European market compliance
Injectable Grade
Sterility: Assured Endotoxins: <0.25 EU/mg Particulates: Controlled Application: Parenteral preparations
High Purity Grade
Enhanced Purity: >99.5% Low Impurities: <0.5% Superior Preservation: Verified Application: Critical formulations

Quality Standards

DRAVYOM's Potassium Sorbate is manufactured under stringent cGMP protocols, meeting international pharmaceutical excipient standards including USP, EP, and FDA guidelines for preservative applications.

cGMP Manufacturing Standards
USP/EP Grade Specifications
Assay 99.0-101.0%
Advanced Analytical Testing
Antimicrobial Activity Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Controlled Storage & Shipping

Advanced Chemical Properties & Performance

Pharmaceutical Grade Potassium Sorbate exhibits exceptional chemical properties essential for preservation applications. Its potent antimicrobial structure and superior stability characteristics ensure reliable performance in demanding pharmaceutical preservation systems.

Molecular Properties
Molecular Weight: 150.22 g/mol
Molecular Formula: C6H7KO2
pKa: 4.76
Ionic Character: Potassium salt
Physical Properties
Melting Point: 270°C (decomposes)
Appearance: White crystalline granules/powder
Solubility (Water): 139 g/100 mL (20°C)
Bulk Density: 0.80-0.90 g/cm³
Pharmaceutical Properties
Antimicrobial Activity: Effective against yeasts and molds
pH Range: Most active at pH 4.0-6.5
MIC Range: 0.01-0.3% w/w
Mechanism: Cell membrane disruption
Quality Specifications
Purity: ≥99.0%
Water Content: ≤1.0%
pH (5% solution): 7.0-8.5
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-25°C
Light Sensitivity: Stable to light
Heat Sensitivity: Stable under normal conditions

Performance Characteristics

Detailed performance metrics demonstrate Potassium Sorbate superiority in preservation applications with exceptional antimicrobial activity, broad-spectrum efficacy, and stability across diverse pharmaceutical formulation systems.

Antimicrobial Activity

Potent activity against yeasts and molds

Broad-spectrum preservation
High Solubility

Excellent water solubility for liquid formulations

Easy incorporation
pH Dependent Activity

Optimal preservation at acidic pH values

Enhanced efficacy at pH 4.0-6.5
Heat Stability

Stable under normal processing conditions

Manufacturing compatibility
Regulatory Status

USP/EP/FDA approved preservative

GRAS status
Natural Origin

Derived from sorbic acid

Consumer-friendly preservative

Safety Information

Generally recognized as safe (GRAS) pharmaceutical preservative requiring standard handling protocols. Handle in controlled environments with appropriate ventilation systems. Use proper personal protective equipment and follow established safety protocols for preservative materials.

GRAS Status
Standard PPE Required
Good Manufacturing Practices

Storage & Handling

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

Controlled room temperature (15-25°C)
Store in dry conditions
Tightly closed containers
Preserve antimicrobial activity

Chemical Mechanisms & Reaction Pathways

Potassium sorbate functions as a highly effective preservative through antimicrobial activity against yeasts, molds, and bacteria, providing pharmaceutical formulations with enhanced stability and extended shelf life through inhibition of microbial growth pathways.

Antimicrobial Action

Inhibits enzymatic systems in microorganisms

Prevents microbial growth and reproduction
pH-Dependent Activity

Most effective in slightly acidic conditions (pH 4.5-6.5)

Optimal preservative performance
Broad Spectrum

Effective against yeasts, molds, and select bacteria

Comprehensive microbial protection
Membrane Disruption

Affects microbial cell membrane integrity

Multiple antimicrobial mechanisms

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 Potassium sorbate performance in pharmaceutical applications.

Formulation Development
  • Preservative system optimization
  • pH compatibility studies
  • Stability improvement strategies
  • Multi-dose formulations
Analytical Services
  • Method validation and transfer
  • Preservative efficacy testing
  • Stability testing programs
  • Microbial challenge studies
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Moisture-controlled packaging
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

Our Potassium sorbate 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 Potassium sorbate 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 purity and preservative efficacy

HPLC, microbiological, and stability testing
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Moisture-controlled packaging with contamination prevention

Preservative integrity maintenance

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Potassium sorbate effectiveness across diverse therapeutic applications with quantified performance metrics and preservative validation.

Pharmaceutical Manufacturing
MIC: 0.01-0.3% effective concentration pH Range: 4.5-6.5 optimal activity Purity: >99% pharmaceutical grade
Drug Development
Formulation Support: Liquid and semi-solid dosage forms Regulatory Success: GRAS status preservative Innovation: Multi-dose preservation systems
Clinical Applications
Safety: Well-established preservative profile Efficacy: Proven antimicrobial activity Versatility: Multiple pharmaceutical 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