Calcium Phosphate (Dicalcium Phosphate) USP/EP
Pharmaceutical USP/EP
Pharmaceutical Excipient

Calcium Phosphate (Dicalcium Phosphate) USP/EP

High-purity pharmaceutical grade Dicalcium Phosphate manufactured under stringent cGMP conditions. This versatile mineral excipient is essential for pharmaceutical manufacturing, serving as filler, disintegrant, and calcium supplement in tablet formulations, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical Excipient
  • cGMP Manufacturing Standards
  • Direct Compression Grade Available
  • Comprehensive COA Documentation
  • Multi-functional Mineral Excipient
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: CaHPO4·2H2O
CAS Number: 7789-77-7
Molecular Weight: 172.09 g/mol
Purity (Assay): ≥98.0% (pharmaceutical grade)
Physical State: White crystalline powder
Water Content (Loss on Drying): 18.5-21.0%
Particle Size Distribution: Controlled for direct compression
Heavy Metals (as Pb): ≤10 ppm
Fluoride Content: ≤0.003%
Storage Conditions: Store in cool, dry place (15-30°C)
Packaging Options: 25kg, 50kg pharmaceutical drums

Applications

Tablet Manufacturing & Compression
Pharmaceutical Excipient
Calcium Supplement Formulations
Disintegrant Applications
Mineral Research & Development
Pharmaceutical Research
Drug Product Manufacturing
Quality Control Testing
Regulatory Compliance
Formulation Development
Analytical Method Development
Reference Standard Applications

Industry-Specific Grades

DRAVYOM offers specialized Calcium Phosphate grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse tablet manufacturing and supplement applications.

USP Grade (Pharmaceutical)
Purity: ≥98.0% (assay) Water Content: 18.5-21.0% Heavy Metals: ≤10 ppm Application: Pharmaceutical excipient
EP Grade (European Pharmacopoeia)
Purity: ≥98.0% (pharmaceutical) Fluoride: ≤0.003% Particle Size: Controlled Application: European market compliance
Direct Compression Grade
Purity: ≥98.5% (pharmaceutical) Particle Size: Optimized Flowability: Enhanced Application: Direct compression tablets
GMP Grade
Purity: ≥99.0% (pharmaceutical) Microbial Limits: Compliant Endotoxins: ≤5.0 EU/g Application: Calcium supplement formulations

Quality Standards

DRAVYOM's pharmaceutical grade Calcium Phosphate 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
≥98.0% Pharmaceutical Purity
Advanced Analytical Testing
Comprehensive Impurity Control
Batch-to-Batch Consistency
Complete Documentation Package
Controlled Logistics

Advanced Chemical Properties & Performance

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

Analytical Properties
Solubility (Water): Practically insoluble
pH (1% suspension): 6.5-9.0
Ca/P ratio: 1.5-1.67
Particle Size: D50: 5-25 μm
Physical Properties
Decomposition Temp: 1360°C
Bulk Density: 0.8-1.2 g/mL
Crystalline Form: White, fine crystalline powder
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Disintegration Time: Fast disintegrating
Compressibility: Excellent
Flowability: Good flow properties
Bioavailability: High calcium release
Purity Specifications
Assay (Calcium): 34.0-40.0%
Assay (Phosphorus): 18.0-20.0%
Heavy Metals: ≤10 ppm
Loss on Ignition: ≤2.0%
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Not light sensitive
Temperature Stability: Stable at room temperature
Container Compatibility: HDPE, paper bags

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Calcium Phosphate superiority in excipient applications with exceptional tablet disintegration, binding properties, and reproducibility across diverse pharmaceutical formulations and nutritional supplement protocols.

Tablet Binding

Excellent binding and compression properties

Superior tablet formation
Disintegration

Fast disintegrating tablet excipient

Rapid drug release
Bioavailability

High calcium bioavailability achieved

Excellent absorption characteristics
Temperature Stability

Stable under ambient conditions

Consistent performance at room temperature
Batch Reproducibility

Variation: ±0.2% between batches

Exceptional lot-to-lot consistency
Shelf Stability

5 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Handle with standard pharmaceutical safety precautions. Use appropriate personal protective equipment including safety goggles, gloves, and protective clothing. Avoid inhalation of powder and ensure adequate ventilation in work areas. Follow established pharmaceutical handling protocols.

GRAS Status
Avoid Inhalation
Wear Gloves

Storage & Handling

Store in original containers in a cool, dry place protected from moisture. Keep containers tightly closed and maintain dry storage conditions. Use appropriate handling equipment and ensure controlled environment.

Store at room temperature
Protect from moisture
Original packaging
Keep containers tightly closed

Chemical Mechanisms & Reaction Pathways

Dicalcium Phosphate exhibits excellent pharmaceutical functionality through controlled dissolution and optimal calcium bioavailability, enabling predictable therapeutic response with well-characterized pharmacokinetic and pharmacodynamic profiles.

Mechanism of Action

Controlled dissolution providing sustained calcium release

Optimal calcium bioavailability profile
Absorption Pathway

Duodenal absorption via calcium transport mechanisms

Predictable bioavailability enhancement
Pharmacokinetics

pH-dependent dissolution with sustained release

Suitable for sustained-release formulations
Functionality

Dual excipient-nutrient pharmaceutical role

Multifunctional pharmaceutical ingredient

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 Dicalcium Phosphate 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 Dicalcium Phosphate 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 Dicalcium Phosphate 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 Dicalcium Phosphate effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Formulations
Bioavailability: High calcium absorption Functionality: Dual excipient-nutrient role Stability: 5+ years shelf life
Clinical Applications
Efficacy: 90% dissolution compliance Safety: GRAS status recognition Dosage: 200-1000mg daily range
Manufacturing Data
Purity: >99.0% pharmaceutical grade Consistency: ±0.2% batch variation Yield: >98% 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