Saccharin Sodium
Pharmaceutical Premium
Pharmaceutical Excipient

Saccharin Sodium

High-purity pharmaceutical Saccharin Sodium manufactured to meet stringent USP and EP specifications for sweetening applications. Our Saccharin Sodium provides excellent sweetening properties with superior solubility for various pharmaceutical and oral formulations.

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

Chemical Formula: C7H4NNaO3S·2H2O
CAS Number: 128-44-9
EINECS Number: 204-886-1
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White crystalline powder
Molecular Weight: 241.19 g/mol
Melting Point: 226-230°C
pH (1% solution): 6.0-7.5
Loss on Drying: ≤15.0%
Residue on Ignition: ≤0.2%
Heavy Metals: ≤10 ppm
Solubility: Freely soluble in water
Storage Conditions: Store at 15-30°C, protect from moisture
Shelf Life: 3 years from manufacture date
Packaging Options: 500g, 1kg, 5kg containers

Applications

Pharmaceutical Sweetener
Tablet Formulations
Liquid Formulations
Capsule Manufacturing
Oral Solutions
Syrups & Suspensions
Pediatric Formulations
Diabetic Medications
Oral Care Products
Nutraceuticals
Research Applications
Food Grade Applications

Industry-Specific Grades

DRAVYOM offers specialized Saccharin Sodium grades tailored for specific pharmaceutical and nutraceutical applications, ensuring optimal sweetening properties and regulatory compliance across diverse formulation requirements.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤15.0% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% Sulfated Ash: ≤0.2% Residual Solvents: EP limits Application: European market compliance
Research Grade
Purity: ≥98.0% Sweetness: 300-500x sucrose Stability: Enhanced Application: R&D applications
Food Grade
Purity: ≥99.0% Safety: FDA GRAS status Quality: Food-grade compliance Application: Nutraceuticals

Quality Standards

DRAVYOM's Saccharin Sodium is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and FDA guidelines for sweetening applications.

cGMP Manufacturing Standards
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
Consistent Sweetening Power
Batch-to-Batch Consistency
Comprehensive COA Documentation
Controlled Storage & Shipping

Advanced Chemical Properties & Performance

Pharmaceutical Grade Saccharin Sodium exhibits exceptional chemical properties essential for sweetening applications. Its potent artificial sweetener structure and superior stability characteristics ensure reliable performance in demanding pharmaceutical formulation and flavoring systems.

Molecular Properties
Molecular Weight: 205.17 g/mol
Molecular Formula: C7H4NNaO3S · 2H2O
LogP (Octanol/Water): -1.6
pKa: 1.6
Physical Properties
Melting Point: 226-230°C (decomposes)
Appearance: White crystalline powder
Solubility (Water): Freely soluble (1 in 1.2)
Bulk Density: 0.70-0.80 g/cm³
Pharmaceutical Properties
Sweetening Power: 300-500 times sucrose
Caloric Value: Essentially zero
pH Stability: Stable at pH 2-10
Heat Stability: Stable up to 150°C
Quality Specifications
Purity: ≥99.0%
Water Content: 15-17% (dihydrate)
Insoluble Matter: ≤0.2%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 5 years (unopened)
Storage Temperature: 15-25°C
Light Sensitivity: Stable to light
Hydrolysis Resistance: Stable in aqueous solutions

Performance Characteristics

Detailed performance metrics demonstrate Saccharin Sodium superiority in sweetening applications with exceptional sweetening potency, zero caloric contribution, and stability across diverse pharmaceutical formulation and processing systems.

High Sweetening Power

300-500 times sweeter than sucrose

Intense sweetness with minimal quantity
Zero Calories

No caloric contribution to formulations

Diabetic-friendly formulations
Heat Stability

Stable under processing temperatures

Maintains sweetness during manufacturing
pH Stability

Stable across wide pH range

Versatile formulation compatibility
Regulatory Status

FDA/GRAS approved artificial sweetener

Global regulatory acceptance
High Solubility

Excellent water solubility

Easy incorporation in liquid formulations

Safety Information

Generally recognized as safe (GRAS) artificial sweetener requiring standard handling protocols. Handle in controlled environments with appropriate dust control measures. Use proper personal protective equipment and follow established safety protocols for food additive materials.

GRAS Status
Standard PPE Required
Dust Control Measures

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 sweetening potency and pharmaceutical quality.

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

Chemical Mechanisms & Reaction Pathways

Saccharin Sodium exhibits specific sweetening receptor mechanisms essential for pharmaceutical taste-masking applications. Its molecular structure enables selective taste receptor binding with predictable sweetening therapeutic responses.

Sweetening Mechanism

T1R2/T1R3 sweet taste receptor binding and activation

Intense sweetness without calories
Metabolic Pathways

Minimal metabolism with largely unchanged renal excretion

Non-caloric sweetening agent
Stability Profile

Excellent thermal and pH stability across formulation ranges

Versatile pharmaceutical excipient
Functional Effects

Taste-masking and palatability enhancement properties

Improved patient compliance

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia pharmaceutical standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical quality

ICH Guidelines

International Conference on Harmonization standards compliance

GMP Certification

Good Manufacturing Practices certified production facility

DMF Support

Drug Master File documentation for regulatory submissions

CEP Available

Certificate of Suitability to European Pharmacopoeia monographs

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, regulatory assistance, and technical services to optimize pharmaceutical performance in your specific drug development applications.

Formulation Development
  • Dosage form optimization support
  • Stability testing guidance
  • Bioavailability enhancement
  • Custom formulation development
Analytical Services
  • Method development and validation
  • Impurity profiling and identification
  • Stability indicating methods
  • Dissolution testing support
Regulatory Support
  • Regulatory submission assistance
  • DMF preparation and maintenance
  • Pharmacovigilance support
  • Global registration strategy
Supply Solutions
  • Pharmaceutical supply chain management
  • Cold chain logistics
  • Custom packaging solutions
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical production emphasizes environmental responsibility through sustainable manufacturing practices, green chemistry principles, and comprehensive environmental impact management for pharmaceutical operations.

Green Chemistry

Sustainable synthetic routes with minimal environmental impact

Water Management

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Packaging

Recyclable pharmaceutical packaging solutions

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 quality and performance across all production batches.

Production Process

Advanced synthesis and purification in GMP-controlled clean-room environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive testing protocol including purity, potency, and impurity profiling

HPLC, GC-MS, and spectroscopic analysis
Quality Systems

ISO 9001:2015 and GMP quality management systems

Continuous improvement and validation protocols
Packaging Control

Pharmaceutical-grade packaging with controlled atmosphere

Contamination prevention and stability protection

Market Applications & Performance Data

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

Pharmaceutical Development
Formulation Success: 95+ formulations developed Regulatory Approvals: 100+ successful submissions Quality Consistency: 99.9% batch compliance
Research Applications
Clinical Studies: 200+ supported trials Publication Support: 150+ peer-reviewed papers Innovation: Custom API development
Commercial Manufacturing
Scale-up Success: 100% process transfers Supply Reliability: 99.8% on-time delivery Cost Optimization: 25% average cost reduction

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds pharmacopeial specifications with superior purity and pharmaceutical performance

Reliable Supply

Guaranteed pharmaceutical availability with strategic inventory and GMP production scheduling

Development Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Regulatory Assurance

Complete regulatory packages with DMF support and global registration assistance

Global Standards

International compliance with USP, EP, and ICH standards for worldwide market access

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services