Sodium Starch Glycolate (SSG) - Pharmaceutical Ingredient
Pharmaceutical Disintegrant
Pharmaceutical Ingredient

Sodium Starch Glycolate (SSG)

Premium pharmaceutical-grade sodium starch glycolate engineered for demanding drug formulation applications including tablet disintegration, fast release, and dissolution enhancement. Our high-performance disintegrant delivers exceptional swelling efficiency, consistent performance, and reliable supply for critical pharmaceutical manufacturing processes requiring superior disintegration properties with stringent regulatory compliance standards.

  • USP/EP/IP Grade Compliance
  • pH 6.0-8.0 Range
  • ≤10.0% Loss on Drying
  • Rapid Disintegration
  • Fast Release Formulations
  • Superior Swelling Properties
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Technical Specifications

Chemical Name: Sodium Starch Glycolate (SSG)
CAS Number: 9063-38-1
Type: Superdisintegrant
Physical State: White to off-white powder
Loss on Drying: ≤ 10.0%
pH (1% suspension): 6.0-8.0
Sodium Content: 2.8-4.2%
Particle Size (D50): 30-100 μm
Bulk Density: 0.4-0.8 g/cm³
Tapped Density: 0.6-1.0 g/cm³
Heavy Metals (as Pb): ≤ 20 ppm
Microbial Limits: ≤ 1000 CFU/g
Disintegration Time: < 30 seconds
Shelf Life: 5 years
Packaging Options: 25kg fiber drums

Applications

Tablet Disintegrant
Capsule Disintegrant
Direct Compression
Wet Granulation
Rapid Release Formulations
Orally Disintegrating Tablets

Industry-Specific Grades

DRAVYOM offers specialized SSG grades tailored for different pharmaceutical formulation requirements, ensuring optimal disintegration performance and regulatory compliance.

Standard Grade
Disintegration: Fast Particle Size: Controlled Flow Properties: Good Application: General tablets
Direct Compression Grade
Compressibility: Excellent Flowability: Enhanced Uniformity: High Application: DC formulations
ODT Grade
Super Disintegration: Ultra fast Mouth Feel: Smooth Wetting: Rapid Application: ODT tablets
Multi-functional Grade
Dual Function: Binder & disintegrant Cost Effective: Optimized Versatile: Multi-purpose Application: Complex formulations

Quality Standards

DRAVYOM's Sodium Starch Glycolate is manufactured under cGMP conditions, meeting international pharmaceutical standards for superdisintegrant applications.

cGMP Certified Manufacturing
Pharmaceutical Grade Standards
< 30 Seconds Disintegration
USP/EP/IP Compliant
Complete Testing Protocol
ODT Grade Available
Certificate of Analysis
Pharmaceutical Support

Advanced Chemical Properties & Performance

Pharmaceutical Grade material exhibits reliable properties suitable for pharmaceutical formulations and quality manufacturing. Its consistent composition ensures predictable performance in drug development and production environments.

Basic Properties
Pharmaceutical Grade: USP/EP compliant material
Functionality: Excipient performance properties
Compatibility: Compatible with active ingredients
Stability: Stable under pharmaceutical conditions
Physical Properties
Physical Form: Powder or granular material
Particle Size: Controlled particle distribution
Bulk Density: Optimized for processing
Flow Properties: Good flow characteristics
Pharmaceutical Performance
Formulation Suitability: Excellent for drug formulations
Processing: Suitable for various processes
Dissolution: Predictable dissolution behavior
Bioavailability: Does not affect drug bioavailability
Quality Standards
Purity: ≥99.0% pharmaceutical grade
Heavy Metals: ≤10 ppm
Microbial Limits: USP/EP compliant
Residual Solvents: Within ICH Q3C limits
Stability Properties
Shelf Life: 5 years (unopened)
Storage Stability: Stable under controlled conditions
Retest Period: As per pharmacopeial standards
Container Closure: Pharmaceutical grade packaging

Performance Characteristics

Performance metrics demonstrate pharmaceutical grade reliability in drug formulation and manufacturing applications with consistent quality, regulatory compliance, and optimal performance for pharmaceutical processes.

Formulation Performance

Efficiency: Consistent excipient functionality

Excellent for drug formulations
Regulatory Compliance

Standards: USP/EP/BP pharmacopeial compliance

Meets regulatory requirements
Manufacturing Use

Reliability: Consistent performance in production

Suitable for pharmaceutical manufacturing
Quality Assurance

Validation: Comprehensive quality testing

Validated pharmaceutical material
Batch Consistency

Variation: ±1% between batches

Superior batch-to-batch consistency
Shelf Life

Duration: 5 years under proper storage

Extended stability for pharmaceutical use

Safety Information

Generally safe for pharmaceutical use when handled according to Good Manufacturing Practices. Use appropriate protective equipment including gloves and safety goggles during handling. Follow pharmaceutical handling protocols and maintain clean room standards where applicable.

Pharmaceutical Safe
GMP Handling
Regulatory Approved

Storage & Handling

Store in original pharmaceutical packaging in a controlled environment as per ICH guidelines. Maintain appropriate temperature and humidity conditions. Use pharmaceutical storage equipment and follow Good Distribution Practices for inventory management.

Store at 15-30°C
Relative humidity ≤60%
Original pharmaceutical packaging
GMP storage conditions

Chemical Mechanisms & Reaction Pathways

Sodium Starch Glycolate exhibits rapid disintegration properties through crosslinked polymer swelling and capillary action, enabling fast tablet breakdown and immediate drug release with predictable pharmaceutical performance.

Swelling Mechanism

Rapid water uptake and crosslinked polymer expansion for tablet disintegration

Essential for immediate release formulations
Capillary Action

Wicking action drawing water into tablet matrix for rapid breakdown

Critical for fast disintegration times
Crosslinking Effect

Optimized crosslinking density for efficient disintegration performance

Enables consistent disintegration behavior
pH Independence

Consistent disintegration performance across pH ranges

Important for reliable drug release

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures pharmaceutical-grade SSG meets international pharmacopeial standards with complete documentation packages supporting drug development and regulatory submissions.

Pharmacopeial Standards

USP, EP, and JP compliance for pharmaceutical excipient applications

GMP Compliance

Good Manufacturing Practice protocols for pharmaceutical excipients

Safety Documentation

GRAS status and pharmaceutical safety assessment documentation

International Registration

DMF filings and excipient master file documentation

Quality Documentation

Certificates of analysis and pharmaceutical quality certificates

Supply Chain

GMP-compliant transportation and pharmaceutical logistics

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical excipient support team provides comprehensive formulation guidance, technical assistance, and regulatory support to optimize SSG applications in pharmaceutical manufacturing.

Formulation Support
  • Disintegration time optimization
  • Direct compression enhancement
  • Tablet hardness balancing
  • Capsule fill applications
Technical Services
  • Particle size optimization
  • Disintegration testing protocols
  • Stability testing guidance
  • Process troubleshooting
Quality Services
  • GMP compliance consultation
  • Method validation support
  • Quality system documentation
  • Pharmacopeial testing protocols
Supply Solutions
  • Pharmaceutical-grade packaging
  • Just-in-time delivery programs
  • Custom particle size grades
  • Inventory management services

Environmental Impact & Sustainability

Our pharmaceutical SSG production emphasizes environmental responsibility through sustainable starch sourcing, energy-efficient processing, and comprehensive environmental impact management for sustainable pharmaceutical development.

Sustainable Sourcing

Renewable starch sources with sustainable agricultural practices

Green Processing

Environmentally friendly crosslinking and modification processes

Clean Production

Energy-efficient manufacturing with emission controls

Waste Management

Pharmaceutical waste minimization and recycling programs

Environmental Standards

ISO 14001 environmental management system compliance

Packaging Solutions

Recyclable pharmaceutical packaging and container programs

Manufacturing Excellence & Quality Control

DRAVYOM's pharmaceutical SSG manufacturing facility employs advanced crosslinking technology and quality systems to ensure consistent pharmaceutical-grade quality and performance across all production batches.

Advanced Processing

Controlled crosslinking and purification technology for consistent disintegration

Optimal crosslinking density and purity control
Quality Testing

Comprehensive testing including disintegration time, particle size, and pharmaceutical properties

USP/EP method validation and compliance
GMP Systems

cGMP compliance with pharmaceutical excipient quality systems

FDA and EMA inspection-ready facilities
Pharmaceutical Packaging

Moisture-controlled packaging with pharmaceutical-grade containers

Stability-optimized packaging systems

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating SSG effectiveness across tablet manufacturing applications with validated performance metrics and pharmaceutical industry adoption for fast disintegration.

Immediate Release Tablets
Disintegration Time: 98% under 30 seconds achievement Performance: Consistent rapid breakdown Customer Satisfaction: 96% pharmaceutical approval
Direct Compression
Compression Properties: Superior flowability characteristics Process Efficiency: 35% disintegration time reduction Market Share: 65% superdisintegrant segment
Capsule Applications
Fill Performance: Enhanced powder flow properties Cost Effectiveness: 20% formulation cost savings Dissolution: 40% faster drug release rates

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

cGMP-compliant SSG manufacturing with pharmaceutical regulatory expertise and formulation support

Processing Innovation

Advanced crosslinking technology with custom particle size grades and disintegration optimization

Quality Assurance

Comprehensive quality control with pharmaceutical-grade documentation and batch traceability

Reliable Supply

Consistent pharmaceutical supply chain with just-in-time delivery and inventory management

Regulatory Support

DMF filing assistance with regulatory submission support and global compliance expertise

Partnership Approach

Long-term pharmaceutical partnerships with formulation development and technical collaboration