Starch USP/EP
Pharmaceutical USP/EP
Pharmaceutical Excipient

Starch USP/EP

High-purity pharmaceutical grade Starch manufactured under stringent cGMP conditions. This natural excipient is essential for pharmaceutical manufacturing, serving as filler, disintegrant, and binder in tablet formulations, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical Excipient
  • cGMP Manufacturing Standards
  • Natural Corn-based Excipient
  • Comprehensive COA Documentation
  • Multi-functional Tablet Excipient
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Name: Starch (Corn-based)
CAS Number: 9005-25-8
Physical State: White to off-white powder
pH (10% suspension): 5.0-7.0
Loss on Drying: ≤15.0%
Residue on Ignition: ≤0.5%
Particle Size (d90): ≤75 µm
Bulk Density: 0.4-0.8 g/cm³
Heavy Metals (as Pb): ≤10 ppm
Reducing Sugars: ≤0.3%
Protein Content: ≤0.35%
Solubility: Practically insoluble in water
Storage Conditions: Store at room temperature, dry place
Shelf Life: 5 years from date of manufacture
Packaging Options: 25kg, 50kg pharmaceutical containers

Applications

Tablet Filler
Tablet Binder
Disintegrant
Capsule Filler
Pharmaceutical Excipient
Dusting Powder
Suspension Agent
Diluent
Natural Excipient
Generic Formulations
Direct Compression
USP/EP Applications

Industry-Specific Grades

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

USP Grade (United States Pharmacopeia)
pH: 5.0-7.0 (10% suspension) Heavy Metals: ≤10 ppm Protein Content: ≤0.35% Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Loss on Drying: ≤15.0% Reducing Sugars: ≤0.3% Particle Size: Controlled Application: EU regulatory submissions
Tablet Grade
Compressibility: Excellent Flow Properties: Good Binding Capacity: Optimized Application: Tablet manufacturing
Direct Compression Grade
Bulk Density: Controlled Flowability: Enhanced Moisture Content: Optimized Application: Direct compression

Quality Standards

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

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
Natural Corn-Based Excipient
Advanced Particle Size Testing
Multi-functional Excipient
Batch-to-Batch Consistency
Comprehensive COA
Pharmaceutical Grade Packaging

Advanced Chemical Properties & Performance

Pharmaceutical Grade Starch exhibits exceptional chemical properties essential for pharmaceutical applications. Its natural polymer composition and precise specification ensure reliable performance in demanding pharmaceutical formulations and drug delivery systems.

Pharmaceutical Properties
Degree of Polymerization: 200-1000 glucose units
Amylose Content: 20-25%
Swelling Power: 15-20 g/g (80°C)
Gel Strength: Moderate to high viscosity
Physical Properties
Gelatinization Temperature: 58-65°C
Particle Size: 5-20 μm (typical)
Bulk Density: 0.4-0.6 g/cm³
Water Solubility: Limited (swells in cold water)
Pharmaceutical Performance
Disintegration Time: 2-8 minutes (tablets)
Binding Efficiency: Good to excellent
Compressibility: Moderate compaction pressure
Drug Compatibility: Excellent with most APIs
Purity Specifications
Starch Content: ≥ 95%
Heavy Metals: ≤ 20 ppm
Sulfur Dioxide: ≤ 50 ppm
Microbial Count: ≤ 1000 CFU/g
Stability Properties
Shelf Life: 3 years (unopened)
Moisture Sensitivity: Hygroscopic (control humidity)
Temperature Stability: Stable 15-30°C
pH Stability: Stable pH 4-9

Performance Characteristics

Detailed performance metrics demonstrate Pharmaceutical Grade Starch superiority in formulation applications with exceptional functionality, stability, and reproducibility across diverse pharmaceutical procedures and therapeutic protocols.

Tablet Disintegration

Time: 2-8 minutes for immediate release tablets

Rapid drug release and bioavailability
Binding Efficiency

Strength: Good to excellent tablet hardness

Robust mechanical properties
Swelling Capacity

Expansion: 15-20 times original volume

Superior disintegrant functionality
Processing Stability

Range: Stable during standard processing

Reliable performance across manufacturing
Batch Uniformity

Variation: ±2% between production batches

Consistent pharmaceutical grade quality
Long-term Stability

3 years shelf life with maintained functionality

Extended pharmaceutical grade integrity

Safety Information

Generally recognized as safe (GRAS) for pharmaceutical and food applications. Natural excipient with excellent biocompatibility and digestibility. Handle with standard laboratory precautions including appropriate protective equipment. Avoid inhalation of powder and ensure proper ventilation during processing.

GRAS Status
Natural Origin
Biocompatible

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from moisture and incompatible materials. Keep containers tightly closed and protect from humidity and direct sunlight. Use appropriate pharmaceutical handling procedures and ensure proper environmental controls for moisture management.

Cool storage (15-30°C)
Low humidity (≤60% RH)
Original sealed containers
Protect from direct sunlight

Chemical Mechanisms & Reaction Pathways

Pharmaceutical Grade Starch exhibits unique polysaccharide properties through amylose and amylopectin components enabling versatile pharmaceutical applications with predictable swelling and binding mechanisms in drug formulations.

Hydration Mechanisms

Controlled water uptake through hydrogen bonding networks

Essential for disintegration and dissolution control
Compression Properties

Plastic deformation under pressure for tablet formation

Critical for direct compression formulations
Gelation Behavior

Temperature-dependent gel formation for controlled release

Enables sustained-release matrix systems
Swelling Kinetics

Predictable swelling rates for drug release control

Fundamental for controlled-release dosage forms

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia pharmaceutical excipient standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical applications

GRAS Status

Generally Recognized as Safe for pharmaceutical use

REACH Registration

European Union chemical regulation compliance

DMF Support

Drug Master File documentation for regulatory submissions

cGMP Certified

Current Good Manufacturing Practice compliance

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, stability testing assistance, and regulatory services to optimize Pharmaceutical Grade Starch performance in your specific drug formulations.

Formulation Development
  • Tablet formulation optimization support
  • Disintegrant performance studies
  • Compression profile analysis
  • Custom grade development
Analytical Services
  • Certificate of Analysis verification
  • Particle size distribution analysis
  • Moisture content testing
  • Microbiological testing
Technical Support
  • Pharmaceutical troubleshooting consultation
  • Storage and handling guidance
  • Process optimization support
  • Manufacturing best practices
Supply Solutions
  • Consistent pharmaceutical-grade supply
  • Just-in-time delivery
  • Bulk packaging options
  • Global distribution network

Environmental Impact & Sustainability

Our Pharmaceutical Grade Starch production emphasizes environmental responsibility through sustainable agricultural sourcing, renewable feedstock utilization, and comprehensive environmental impact management for pharmaceutical operations.

Sustainable Agriculture

Renewable corn and potato-based feedstock with sustainable farming

Water Conservation

Advanced water recycling and treatment systems

Clean Production

Energy-efficient processing with minimal chemical usage

Waste Recovery

Complete utilization of agricultural by-products

ISO 14001

Environmental management system certified production

Biodegradable

Completely biodegradable with minimal environmental impact

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical excipient manufacturing facility employs advanced processing technology and continuous monitoring systems to ensure consistent Pharmaceutical Grade Starch quality and performance across all production batches.

Production Process

Advanced wet-milling and purification in pharmaceutical-grade environment

Multi-stage separation for pharmaceutical purity
Quality Testing

15-point pharmaceutical testing protocol including particle size and flow properties

Microscopic analysis and microbiological testing
Quality Systems

cGMP compliance with pharmaceutical excipient standards

Continuous improvement and process validation
Packaging Control

Moisture-barrier packaging with pharmaceutical-grade materials

Contamination prevention and moisture protection

Market Applications & Performance Data

Comprehensive pharmaceutical formulation data demonstrating Pharmaceutical Grade Starch effectiveness across diverse applications with quantified performance metrics and regulatory validations.

Tablet Manufacturing
Disintegration: <30 seconds average Binding: 95% tablet integrity Compression: Optimized hardness
Capsule Formulations
Flowability: Excellent powder flow Uniformity: ±2% weight variation Stability: 36-month proven stability
Controlled Release
Release Profile: Customizable kinetics Swelling Index: Predictable behavior Matrix Integrity: Sustained performance

DRAVYOM Competitive Advantages

Superior Quality

Consistently exceeds USP specifications with optimal particle size distribution and flow properties

Reliable Supply

Guaranteed availability with agricultural sourcing partnerships and pharmaceutical-grade production

Formulation Expertise

Dedicated pharmaceutical team provides tablet formulation and process optimization support

Quality Assurance

Comprehensive testing with pharmaceutical documentation and regulatory support

Global Standards

International compliance with USP, EP, and cGMP specifications for worldwide acceptance

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services