Croscarmellose Sodium USP/EP
Pharmaceutical USP/EP
Pharmaceutical Excipient

Croscarmellose Sodium USP/EP

High-purity pharmaceutical grade Croscarmellose Sodium manufactured under stringent cGMP conditions. This advanced superdisintegrant excipient is essential for pharmaceutical manufacturing, providing rapid tablet disintegration for optimal drug release, with reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical Excipient
  • cGMP Manufacturing Standards
  • Superior Disintegration Properties
  • Comprehensive COA Documentation
  • Advanced Superdisintegrant
  • Regulatory Compliance Ready
Request Quote Technical Support

Technical Specifications

Chemical Formula: C6H7O6(CH2COONa)n
CAS Number: 74811-65-7
Average Molecular Weight: 90,000-700,000 Da
Purity (Assay): ≥90.0% (pharmaceutical grade)
Physical State: White to off-white fibrous powder
Water Content (Loss on Drying): ≤10.0%
pH (1% suspension): 6.0-8.0
Heavy Metals (as Pb): ≤10 ppm
Degree of Substitution: 0.05-0.15
Storage Conditions: Store in cool, dry place (15-30°C)
Packaging Options: 25kg, 50kg pharmaceutical containers

Applications

Superdisintegrant Applications
Rapid Tablet Disintegration
Oral Pharmaceutical Products
Formulation Optimization
Drug Release Enhancement
Pharmaceutical Research
Drug Product Manufacturing
Quality Control Testing
Regulatory Compliance
Formulation Development
Analytical Method Development
Reference Standard Applications

Industry-Specific Grades

DRAVYOM offers specialized Croscarmellose Sodium grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse disintegrant applications.

USP Grade (Pharmaceutical)
Purity: ≥90.0% (Assay) Water Content: ≤10.0% Heavy Metals: ≤10 ppm Application: Pharmaceutical excipient
EP Grade (European Pharmacopoeia)
Purity: ≥90.0% (pharmaceutical) pH: 6.0-8.0 Degree of Substitution: 0.05-0.15 Application: European market compliance
Research Grade
Purity: ≥85.0% (analytical) Water Content: ≤12.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥95.0% (pharmaceutical) Endotoxins: ≤2.5 EU/g Microbial Limits: Compliant Application: Critical formulations

Quality Standards

DRAVYOM's pharmaceutical grade Croscarmellose Sodium 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
≥90.0% Pharmaceutical Purity
Advanced Analytical Testing
Ultra-Low Impurities
Batch-to-Batch Consistency
Traceable Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

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

Analytical Properties
Solubility (Water): Insoluble, swells rapidly
Swelling Index: 4-8 mL/g
pH (1% slurry): 6.0-8.0
Viscosity: Low viscosity in aqueous media
Physical Properties
Appearance: White to off-white powder
Bulk Density: 0.5-0.8 g/mL
Particle Size: ≤180 μm (80% through 100 mesh)
Moisture Content: ≤10.0%
Pharmaceutical Performance
Disintegration Time: Rapid (2-5 minutes)
Wicking Rate: Fast liquid uptake
Swelling Force: Strong disintegrant action
Compatibility: Compatible with most APIs
Purity Specifications
Assay (Na content): ≥90.0%
Loss on Drying: ≤10.0%
Heavy Metals: ≤10 ppm
Residue on Ignition: 15.0-30.0%
Stability Properties
Shelf Life: 5 years (unopened)
Humidity Sensitivity: Store below 60% RH
Temperature Stability: Stable up to 40°C
Chemical Stability: Stable in neutral pH

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Croscarmellose Sodium superiority in tablet disintegration with exceptional swelling properties, rapid liquid uptake, and reproducibility across diverse formulation requirements.

Swelling Performance

Swelling index: 4-8 mL/g in aqueous media

Rapid tablet disintegration
Wicking Efficiency

Liquid uptake: Fast penetration and distribution

Enhanced drug dissolution
Disintegration Time

Tablet breakdown: 2-5 minutes typical

Consistent performance across batches
Processing Stability

Heat resistance: Stable during compression

Maintains functionality after processing
Batch Reproducibility

Variation: ±5% between batches

Consistent disintegration performance
Shelf Stability

5 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Generally recognized as safe (GRAS) for pharmaceutical use. Non-toxic excipient with excellent safety profile. Handle with standard pharmaceutical safety precautions. May cause mild irritation to eyes and respiratory tract if dispersed as dust. Use appropriate dust control measures during handling.

GRAS Status
Dust Control
Mild Eye Irritant

Storage & Handling

Store in original containers in a cool, dry, well-ventilated area away from moisture. Keep containers tightly closed and maintain pharmaceutical-grade environmental controls. Use appropriate dust control measures and ensure proper material handling procedures.

Cool storage (15-25°C)
Protect from moisture (≤60% RH)
Dust control required
Original packaging only

Chemical Mechanisms & Reaction Pathways

Croscarmellose Sodium exhibits disintegrant properties through rapid water uptake and swelling mechanisms, enabling predictable tablet disintegration with well-characterized physicochemical behavior.

Mechanism of Action

Rapid water uptake with volumetric swelling

Tablet disintegration enhancement
Swelling Mechanism

Cross-linked carboxymethyl cellulose hydration

Superdisintegrant functionality
Physical Properties

Fibrous morphology with high surface area

Optimized particle size distribution
Stability

Chemically stable with consistent performance

pH-independent disintegration

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete documentation packages supporting international drug registration and regulatory submissions.

USP Monograph

United States Pharmacopeia specifications compliance

EP Standards

European Pharmacopoeia monograph requirements

cGMP Manufacturing

Current Good Manufacturing Practices compliance

ICH Guidelines

International Council for Harmonisation standards

DMF Support

Drug Master File documentation assistance

Audit Readiness

Regulatory inspection preparation and support

Technical Support & Value-Added Services

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

Formulation Development
  • Excipient compatibility studies
  • Stability testing protocols
  • Dissolution optimization
  • Bioavailability enhancement
Analytical Services
  • Method validation support
  • Impurity identification
  • Stability indicating methods
  • Pharmaceutical testing
Technical Support
  • Regulatory compliance guidance
  • Quality assurance protocols
  • Manufacturing process support
  • Documentation preparation
Supply Solutions
  • Pharmaceutical grade scheduling
  • Global regulatory shipping
  • Custom packaging options
  • Emergency supply protocols

Environmental Impact & Sustainability

Our Croscarmellose Sodium production emphasizes environmental responsibility through sustainable pharmaceutical manufacturing practices, waste minimization, and comprehensive environmental impact management.

Waste Minimization

Optimized synthesis with minimal pharmaceutical waste

Water Treatment

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Pharmaceutical waste management guidance

ISO 14001

Environmental management system certification

Green Chemistry

Sustainable pharmaceutical synthesis methods

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Croscarmellose Sodium quality and performance across all production batches.

cGMP Production

Current Good Manufacturing Practices in controlled pharmaceutical environment

FDA and WHO-GMP certified facility
Quality Testing

Comprehensive pharmaceutical testing including identity, purity, and potency

USP/EP monograph compliance verification
Quality Systems

ISO 9001:2015 with pharmaceutical quality management

Continuous improvement and validation
Packaging Control

Pharmaceutical-grade packaging with moisture protection

Stability and contamination prevention

Market Applications & Performance Data

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

Pharmaceutical Formulations
Functionality: Superdisintegrant excipient Concentration: 1-8% w/w typical usage Stability: 5+ years ambient storage
Clinical Applications
Efficacy: Rapid tablet disintegration Safety: GRAS status excipient Dosage: Variable based on formulation
Manufacturing Data
Purity: >99.5% pharmaceutical grade Consistency: ±0.3% batch variation Yield: >95% synthesis efficiency

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with exceptional pharmaceutical quality and performance

Reliable Supply

Guaranteed pharmaceutical-grade availability with cGMP production scheduling

Development Expertise

Dedicated pharmaceutical development team providing formulation and regulatory support

Quality Assurance

Comprehensive COA with pharmaceutical testing and regulatory compliance documentation

Global Standards

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

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom API development