Sodium Citrate
Pharmaceutical Premium
Pharmaceutical Excipient

Sodium Citrate

High-purity pharmaceutical Sodium Citrate manufactured to meet stringent USP and EP specifications for buffering applications. Our Sodium Citrate provides excellent buffering properties with superior stabilizing capabilities for various pharmaceutical formulations.

  • USP/EP Pharmaceutical Grade
  • Superior Buffering Properties
  • Excellent Stabilizing Properties
  • Enhanced pH Control
  • Consistent Quality
  • Ultra-Low Impurities

Technical Specifications

Chemical Formula: Na3C6H5O7·2H2O
CAS Number: 6132-04-3
Molecular Weight: 294.10 g/mol
Physical State: White crystalline powder
Purity: ≥99.0% (USP/EP Grade)
pH (5% solution): 7.5-9.0
Loss on Drying: 10.0-13.0%
Chlorides: ≤0.005%
Sulfates: ≤0.01%
Heavy Metals (as Pb): ≤10 ppm
Iron: ≤5 ppm
Solubility: Freely soluble in water
Storage Conditions: Store at room temperature
Shelf Life: 5 years from date of manufacture
Packaging Options: 25kg, 50kg pharmaceutical containers

Applications

Buffer Solutions
pH Stabilization
Injectable Formulations
Effervescent Tablets
Oral Solutions
Anticoagulant Solutions
Pharmaceutical Stabilizer
Laboratory Reagents
Chelating Agent
pH Adjustment
Food Grade Applications
USP/EP Applications

Industry-Specific Grades

DRAVYOM offers specialized Sodium Citrate grades tailored for specific pharmaceutical and food applications, ensuring optimal buffering performance and regulatory compliance across diverse stabilization applications.

USP Grade (United States Pharmacopeia)
Purity: ≥99.0% Heavy Metals: ≤10 ppm Chlorides: ≤0.005% Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% pH: 7.5-9.0 (5% solution) Iron: ≤5 ppm Application: EU regulatory submissions
Injectable Grade
Purity: ≥99.5% Endotoxin: ≤0.5 EU/g Sterility: Compliant Application: Injectable formulations
Food Grade
Purity: ≥99.0% Microbiology: Compliant E331 Specification: Met Application: Food applications

Quality Standards

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

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
≥99.0% Purity
Advanced Buffering Testing
Buffer Capacity Verified
Batch-to-Batch Consistency
Comprehensive COA
Pharmaceutical Grade Packaging

Advanced Chemical Properties & Performance

Pharmaceutical Grade Sodium Citrate exhibits exceptional chemical properties essential for buffering and chelation applications. Its potent pH buffering structure and superior stability characteristics ensure reliable performance in demanding pharmaceutical formulation and stabilization systems.

Molecular Properties
Molecular Weight: 294.10 g/mol (dihydrate)
Molecular Formula: Na3C6H5O7 · 2H2O
LogP (Octanol/Water): -3.4
pKa: 3.1, 4.8, 6.4
Physical Properties
Melting Point: 300°C (decomposes)
Appearance: White granular crystals
Solubility (Water): Freely soluble (1 in 1.5)
Bulk Density: 0.80-0.90 g/cm³
Pharmaceutical Properties
Buffer Capacity: Excellent pH buffering
pH Range: 5.5-6.5 (1% solution)
Chelation: Metal ion chelating properties
Osmolality: Contributes to osmotic balance
Quality Specifications
Purity: ≥99.0%
Water Content: 11.0-13.0% (dihydrate)
Chloride: ≤50 ppm
Heavy Metals: ≤5 ppm
Stability Properties
Shelf Life: 5 years (unopened)
Storage Temperature: 15-25°C
Light Sensitivity: Stable to light
pH Stability: Stable across wide pH range

Performance Characteristics

Detailed performance metrics demonstrate Sodium Citrate superiority in buffering applications with exceptional pH control, metal chelation efficacy, and stability across diverse pharmaceutical formulation and processing systems.

pH Buffering

Excellent pH buffering capacity

Maintains stable pH in formulations
Metal Chelation

Effective metal ion chelating properties

Prevents metal-catalyzed degradation
High Solubility

Excellent water solubility

Easy incorporation in aqueous formulations
Stabilizing Effect

Enhances formulation stability

Protects active ingredients
Regulatory Status

FDA/GRAS approved excipient

Global regulatory acceptance
Osmotic Properties

Contributes to osmotic balance

Injectable formulation compatibility

Safety Information

Generally recognized as safe (GRAS) pharmaceutical excipient requiring standard handling protocols. Handle in controlled environments with appropriate dust control measures. Use proper personal protective equipment and follow established safety protocols for buffer 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 buffering capacity and pharmaceutical quality.

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

Chemical Mechanisms & Reaction Pathways

Sodium Citrate exhibits specific buffering and chelating mechanisms essential for pharmaceutical formulation. Its molecular structure enables effective pH control and metal ion sequestration with predictable formulation therapeutic responses.

Buffering System

Tribasic acid buffering with multiple pKa values for pH control

Physiological pH stabilization
Metal Chelation

Citrate ligand formation with divalent and trivalent metal ions

Antioxidant preservation
Solubility Enhancement

Improved dissolution and bioavailability of active compounds

Enhanced drug absorption
Stabilization Effects

Prevents precipitation and maintains solution clarity

Pharmaceutical stability assurance

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