Sodium Starch Glycolate
Pharmaceutical USP/EP
Pharmaceutical Excipient

Sodium Starch Glycolate

Premium pharmaceutical grade disintegrant manufactured to meet stringent USP and EP specifications for tablet and capsule formulations. Provides excellent disintegration properties with superior flow characteristics and consistent performance in pharmaceutical manufacturing.

  • USP/EP Grade Compliance
  • Fast Disintegration Properties
  • Excellent Flow Characteristics
  • Low Moisture Content
  • Consistent Particle Size
  • High Purity Grade
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Technical Specifications

Chemical Name: Sodium Starch Glycolate
CAS Number: 9063-38-1
Physical State: White to off-white powder
pH (1% suspension): 6.0-8.0
Loss on Drying: ≤10.0%
Particle Size (d90): ≤100 µm
Bulk Density: 0.4-0.8 g/cm³
Tapped Density: 0.6-1.2 g/cm³
Heavy Metals (as Pb): ≤20 ppm
Sodium Content: 4.2-6.6%
Chlorides: ≤0.35%
Microbial Limits: TAMC ≤10³ CFU/g
Storage Conditions: Store at room temperature
Shelf Life: 5 years from date of manufacture
Packaging Options: 25kg, 50kg pharmaceutical containers

Applications

Tablet Disintegrant
Capsule Disintegrant
Fast Disintegration
Flow Enhancement
Pharmaceutical Excipient
Tablet Compression
Water Uptake Enhancement
Immediate Release
Pharmaceutical Research
Generic Formulations
Direct Compression
USP/EP Applications

Industry-Specific Grades

DRAVYOM offers specialized Sodium Starch Glycolate grades tailored for specific pharmaceutical disintegration requirements, ensuring optimal performance and regulatory compliance across diverse tablet and capsule applications.

USP Grade (United States Pharmacopeia)
pH: 6.0-8.0 (1% suspension) Heavy Metals: ≤20 ppm Sodium Content: 4.2-6.6% Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Loss on Drying: ≤10.0% Chlorides: ≤0.35% Particle Size: Controlled Application: EU regulatory submissions
Fast Disintegrating Grade
Disintegration: <30 seconds Water Uptake: Enhanced Particle Size: Optimized Application: Fast dissolving tablets
Direct Compression Grade
Flow Properties: Excellent Compressibility: Optimized Bulk Density: Controlled Application: Direct compression

Quality Standards

DRAVYOM's Sodium Starch Glycolate is manufactured under stringent quality control protocols, meeting international pharmaceutical standards including USP, EP specifications. Our disintegrant-grade production ensures consistent performance and regulatory compliance.

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
Pharmaceutical Grade Quality
Advanced Disintegration Testing
Fast Disintegration Properties
Batch-to-Batch Consistency
Comprehensive COA
Pharmaceutical Grade Packaging

Advanced Chemical Properties & Performance

Sodium Starch Glycolate exhibits exceptional disintegrant properties essential for pharmaceutical tablet applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding rapid disintegration formulations.

Molecular Properties
Molecular Weight: Variable polymer
LogP: Hydrophilic
pKa: Not applicable
Bioavailability: Non-absorbed excipient
Physical Properties
Decomposition: 280-300°C
Solubility (Water): Insoluble (swells)
Crystalline Form: Cross-linked polymer
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
Disintegration Time: <5 minutes
Swelling Capacity: 300-800%
Selectivity: Superdisintegrant
Stability: Stable in dry conditions
Purity Specifications
Assay: USP/EP compliant
Sodium Content: 4.2-6.8%
Heavy Metals: ≤10 ppm
Microbial Limits: USP compliant
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Not light sensitive
Temperature Stability: Room temperature stable
pH Stability: Stable pH 3-11

Performance Characteristics

Detailed performance metrics demonstrate Sodium Starch Glycolate superiority in pharmaceutical applications with exceptional disintegration properties, swelling capacity, and reproducibility across diverse tablet formulations.

Disintegration

Time: <5 minutes rapid breakdown

Fast tablet disintegration
Swelling Capacity

Expansion: 300-800% volume increase

Excellent water uptake
Stability

Solid state: >5 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 15-40°C processing

Stable during formulation
Batch Reproducibility

Variation: ±0.3% between batches

Consistent lot-to-lot performance
Shelf Stability

5 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade excipient requiring standard handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for pharmaceutical excipients and ensure proper waste disposal procedures.

Pharmaceutical Excipient
Avoid Skin Contact
Avoid Inhalation

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from moisture. Keep containers tightly closed and protect from humidity. Use appropriate containment measures for pharmaceutical excipient handling.

Room temperature storage (15-25°C)
Protect from moisture
Original sealed containers
Pharmaceutical containment required

Chemical Mechanisms & Reaction Pathways

Sodium Starch Glycolate exhibits specific super-disintegrant mechanisms essential for pharmaceutical tablet formulation. Its molecular structure enables rapid water uptake and swelling with predictable disintegration therapeutic responses.

Disintegration Mechanism

Cross-linked starch with rapid water uptake and swelling

Super-disintegrant action
Swelling Properties

Rapid volume expansion facilitating tablet breakdown

Enhanced drug dissolution
Wicking Action

Improved water penetration through tablet matrix

Accelerated disintegration
Deformation Recovery

Elastic recovery properties enhance tablet performance

Optimal bioavailability

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