Acesulfame Potassium
Pharmaceutical Premium
Pharmaceutical Excipient

Acesulfame Potassium

High-purity pharmaceutical Acesulfame Potassium manufactured to meet stringent USP and EP specifications for sweetening applications. Our Acesulfame Potassium provides excellent sweetening properties with superior stability and enhanced solubility for various pharmaceutical formulations.

  • USP/EP Pharmaceutical Grade
  • Superior Sweetening Properties
  • Excellent Stability
  • Enhanced Solubility
  • Consistent Quality
  • Ultra-Low Impurities
Request Quote Technical Support

Technical Specifications

Chemical Formula: C4H4KNO4S
CAS Number: 55589-62-3
EINECS Number: 259-715-3
Molecular Weight: 201.24 g/mol
Purity (Assay): ≥99.0% (pharmaceutical grade)
Physical State: White crystalline powder
pH (1% aqueous solution): 6.5-7.5
Water Content (Karl Fischer): ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤5 ppm
Sweetness Intensity: 200x sweeter than sucrose
Particle Size (D90): ≤100 μm
Storage Conditions: Store in cool, dry place (15-30°C)
Packaging Options: 25kg, 50kg pharmaceutical bags

Applications

Pharmaceutical Tablets
Liquid Pharmaceutical Formulations
Oral Pharmaceutical Products
Sweetening Agent Development
Diabetic Pharmaceutical Products
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 Acesulfame Potassium grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse drug manufacturing applications.

USP Grade (Pharmaceutical)
Purity: ≥99.0% (Assay) Water Content: ≤0.5% Heavy Metals: ≤5 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
Food Grade
Purity: ≥98.0% (food grade) Water Content: ≤1.0% Particle Size: Controlled Application: Food & beverage applications
GMP Grade
Purity: ≥99.5% (pharmaceutical) Endotoxins: ≤2.5 EU/mg Microbial Limits: Compliant Application: Oral dosage forms

Quality Standards

DRAVYOM's pharmaceutical grade Acesulfame Potassium 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
Comprehensive Impurity Control
Batch-to-Batch Consistency
Complete Documentation Package
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

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

Analytical Properties
Solubility (Water): 270 g/L at 25°C
LogP (octanol/water): -1.33
pKa: 2.0 ± 0.1
UV λmax: 227 nm (water)
Physical Properties
Melting Point: >225°C (decomp.)
Bulk Density: 0.8-1.0 g/mL
Crystalline Form: White crystalline powder
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Sweetness Intensity: 200x sucrose
Thermal Stability: Stable up to 200°C
pH Stability: Stable pH 3-7
Caloric Value: 0 kcal/g
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤1.0% total
Water Content: ≤1.0% (Karl Fischer)
Residue on Ignition: ≤0.2%
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Stable to light
Temperature Stability: Stable 15-25°C
Hydrolysis Resistance: Excellent stability

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Acesulfame Potassium superiority in pharmaceutical sweetening applications with exceptional stability, precision, and reproducibility across diverse formulation protocols and processing procedures.

Pharmaceutical Performance

Assay: ≥99.0% active sweetening agent

Exceptional purity for pharmaceutical formulations
Thermal Stability

Decomposition: >225°C thermal resistance

Superior processing stability
Dissolution Rate

Solubility: 270 g/L rapid dissolution

Excellent formulation compatibility
Storage Stability

Working range: 15-25°C optimal storage

Maintains sweetness across temperature range
Batch Consistency

Variation: ±0.1% between manufacturing batches

Exceptional lot-to-lot reproducibility
Extended Stability

5 years shelf life under recommended conditions

Long-term pharmaceutical grade integrity

Safety Information

Generally recognized as safe (GRAS) pharmaceutical excipient when used according to good manufacturing practices. Use standard laboratory safety measures including appropriate personal protective equipment. Avoid dust inhalation and ensure adequate ventilation during handling operations.

GRAS Status
Standard Precautions
Avoid Dust

Storage & Handling

Store in original containers in a cool, dry area (15-25°C) away from strong odors and incompatible materials. Keep containers tightly closed and protect from moisture. Use standard pharmaceutical storage protocols and ensure proper material identification and segregation.

Controlled temperature (15-25°C)
Protect from moisture
Original packaging recommended
Away from strong odors

Chemical Mechanisms & Reaction Pathways

Acesulfame Potassium exhibits artificial sweetening properties through selective taste receptor activation, enabling precise pharmaceutical applications with predictable stability pathways and quantitative sweetness enhancement mechanisms.

Taste Receptor Binding

Selective activation of sweet taste receptors without caloric metabolism

Quantitative sweetness enhancement
Stability Mechanisms

Thermal and chemical stability across pharmaceutical pH ranges

Essential for formulation compatibility
Non-Metabolic Pathway

Excretion unchanged without metabolic conversion

Enables diabetic-friendly formulations
Synergistic Effects

Enhanced sweetness with other pharmaceutical sweeteners

Optimized palatability solutions

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

FDA GRAS Status

Generally Recognized as Safe for pharmaceutical applications

EFSA Approval

European Food Safety Authority approved sweetener

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 Acesulfame Potassium performance in your specific therapeutic applications.

Formulation Development
  • Pharmaceutical formulation optimization support
  • Stability testing guidance
  • Palatability enhancement 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 Acesulfame Potassium 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 Acesulfame Potassium 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 Acesulfame Potassium effectiveness across diverse therapeutic applications with quantified performance metrics and formulation study validations.

Pharmaceutical Manufacturing
Purity: >99.5% pharmaceutical grade Sweetness: 200x sucrose equivalent Stability: 36+ months under controlled conditions
Research Institutions
Formulation Studies: 100+ published research applications Reproducibility: >99% batch-to-batch consistency Innovation: Custom grade development
Generic Manufacturing
Regulatory Success: 100% FDA approval support Cost Efficiency: 20% reduction in manufacturing costs Quality Assurance: Zero batch failures

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmaceutical specifications with ultra-low impurities and exceptional palatability 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 FDA specifications for worldwide acceptance

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services