Citric Acid
Pharmaceutical Premium
Pharmaceutical Excipient

Citric Acid

High-purity pharmaceutical Citric Acid manufactured to meet stringent USP and EP specifications for acidifying applications. Our Citric Acid provides excellent acidifying properties with superior chelating capabilities for various pharmaceutical formulations.

  • USP/EP Pharmaceutical Grade
  • Superior Acidifying Properties
  • Excellent Chelating Properties
  • Enhanced Stability
  • Consistent Quality
  • Ultra-Low Impurities
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Technical Specifications

Chemical Formula: C6H8O7
CAS Number: 77-92-9
Molecular Weight: 192.12 g/mol
Purity (Assay): ≥99.5% (pharmaceutical grade)
Physical State: White crystalline powder
Water Content (Karl Fischer): ≤0.5%
Residue on Ignition: ≤0.05%
Heavy Metals (as Pb): ≤5 ppm
Oxalic Acid: ≤100 ppm
Storage Conditions: Store in cool, dry place (15-30°C)
Packaging Options: 25kg, 50kg pharmaceutical containers

Applications

Pharmaceutical Acidifying Agent
Chelating Agent Applications
Oral Pharmaceutical Products
Buffer System Applications
Effervescent Formulations
Pharmaceutical Research
Drug Product Manufacturing
Quality Control Testing
Regulatory Compliance
Stability Enhancement
Analytical Method Development
Reference Standard Applications

Industry-Specific Grades

DRAVYOM offers specialized Citric Acid grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse excipient applications.

USP Grade (Pharmaceutical)
Purity: ≥99.5% (Assay) Water Content: ≤0.5% Heavy Metals: ≤5 ppm Application: Pharmaceutical excipient
EP Grade (European Pharmacopoeia)
Purity: ≥99.5% (pharmaceutical) Oxalic Acid: ≤100 ppm Residue on Ignition: ≤0.05% Application: European market compliance
Research Grade
Purity: ≥99.0% (analytical) Water Content: ≤1.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.8% (pharmaceutical) Endotoxins: ≤2.5 EU/g Microbial Limits: Compliant Application: Injectable formulations

Quality Standards

DRAVYOM's pharmaceutical grade Citric Acid 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
≥99.5% 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 Citric Acid exhibits exceptional chemical properties essential for pharmaceutical applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Very soluble (133 g/100 mL at 20°C)
LogP (octanol/water): -1.72
pKa: 3.13, 4.76, 6.40
Specific Rotation: Not applicable (achiral)
Physical Properties
Melting Point: 153°C
Bulk Density: 0.8-1.0 g/mL
Crystalline Form: White crystalline powder
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Buffering Capacity: Excellent (pH 2.5-6.5)
Chelating Properties: Strong metal chelation
Antioxidant Activity: Natural antioxidant properties
Compatibility: Compatible with most excipients
Purity Specifications
Assay: ≥99.5%
Water Content: ≤0.5% (Karl Fischer)
Oxalic Acid: ≤100 ppm
Heavy Metals: ≤5 ppm
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Stable to light
Temperature Stability: Stable up to 40°C
pH Stability: Stable in acidic conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Citric Acid superiority in pharmaceutical applications with exceptional buffering capacity, chelating properties, and reproducibility across diverse formulation requirements.

Buffering Performance

pH buffering capacity: Excellent in pH 2.5-6.5 range

Optimal for oral and topical formulations
Chelating Efficacy

Metal chelation: Strong binding with divalent cations

Prevents oxidation and degradation
Dissolution Rate

Solubility: Rapid dissolution in aqueous media

Excellent for immediate release formulations
Thermal Stability

Decomposition temperature: >150°C

Stable during normal processing conditions
Batch Reproducibility

Variation: ±0.1% between batches

Consistent pharmaceutical performance
Shelf Stability

5 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Generally recognized as safe (GRAS) for pharmaceutical use. Mild irritant to eyes and skin in concentrated form. Handle with appropriate protective equipment and ensure proper ventilation during processing. Non-toxic at normal handling concentrations.

Eye Irritant
Skin Irritant
GRAS Status

Storage & Handling

Store in original containers in a cool, dry, well-ventilated area away from incompatible materials. Keep containers tightly closed and protect from moisture. Use appropriate handling equipment and ensure proper hygiene controls for pharmaceutical applications.

Cool storage (15-25°C)
Protect from moisture
Original packaging only
Maintain pharmaceutical hygiene

Chemical Mechanisms & Reaction Pathways

Citric Acid exhibits acidification properties through tricarboxylic acid chemistry, enabling predictable pH adjustment and chelation response with well-characterized pharmaceutical applications.

Mechanism of Action

Tricarboxylic acid with metal chelation properties

pH adjustment and buffering capacity
Metabolic Pathway

Citric acid cycle intermediate, rapidly metabolized

Natural metabolic processing
Pharmacokinetics

Oral administration with rapid absorption

GRAS status for pharmaceutical use
Elimination

Complete metabolic utilization via TCA cycle

CO2 and water end products

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 Citric Acid 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 Citric Acid 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 Citric Acid 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 Citric Acid effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Formulations
Bioavailability: Complete oral absorption Half-life: Rapid metabolic utilization Stability: 5+ years ambient storage
Clinical Applications
Efficacy: Precise pH control Safety: GRAS status Dosage: Variable based on application
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