Creatine Phosphate Disodium Salt USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Creatine Phosphate Disodium Salt USP/EP

High-purity pharmaceutical grade Creatine Phosphate Disodium Salt manufactured under stringent cGMP conditions. This energy metabolism compound API is essential for cardiac therapy applications, particularly in heart failure treatment and myocardial protection, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥98.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Energy Metabolism for Cardiac Therapy
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C4H8N3Na2O5P
CAS Number: 10380-07-3
Molecular Weight: 255.08 g/mol
Purity (HPLC): ≥98.0% (pharmaceutical grade)
Physical State: White to off-white crystalline powder
Water Content (Karl Fischer): ≤5.0%
Residue on Ignition: ≤0.2%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤2.0% total impurities
Storage Conditions: Store in cool, dry place (15-25°C)
Packaging Options: 1kg, 5kg pharmaceutical containers

Applications

Cardiac Therapy Manufacturing
Myocardial Protection Formulations
Injectable Pharmaceutical Products
API Synthesis & Development
Energy Metabolism Research
Pharmaceutical Research
Drug Product Manufacturing
Quality Control Testing
Regulatory Compliance
Clinical Trial Materials
Bioanalytical Method Development
Reference Standard Applications

Industry-Specific Grades

DRAVYOM offers specialized Creatine Phosphate Disodium Salt grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse cardiac therapy drug manufacturing applications.

USP Grade (Pharmaceutical)
Purity: ≥98.0% (HPLC) Water Content: ≤5.0% Heavy Metals: ≤10 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥98.0% (pharmaceutical) Related Substances: ≤2.0% Residue on Ignition: ≤0.2% Application: European market compliance
Research Grade
Purity: ≥97.0% (analytical) Water Content: ≤6.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.0% (pharmaceutical) Endotoxins: ≤0.5 EU/mg Microbial Limits: Compliant Application: Injectable cardiac formulations

Quality Standards

DRAVYOM's pharmaceutical grade Creatine Phosphate Disodium Salt 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
Ultra-Low Impurities
Batch-to-Batch Consistency
Traceable Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

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

Analytical Properties
Solubility (Water): Freely soluble
LogP (octanol/water): -3.2
pKa: 2.6, 12.5
Molecular Weight: 255.08 g/mol
Physical Properties
Appearance: White crystalline powder
Bulk Density: 0.6-0.8 g/mL
Melting Point: Decomposes >200°C
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
Bioavailability: High (IV administration)
Protein Binding: Minimal
Half-life: 2-4 hours
Mechanism: ATP regeneration in cardiac muscle
Purity Specifications
Assay: ≥98.0%
Water Content: ≤8.0% (Karl Fischer)
Heavy Metals: ≤10 ppm
Residue on Ignition: ≤0.2%
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store below 25°C
pH Stability: Stable in neutral to slightly alkaline pH

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Creatine Phosphate Disodium Salt superiority in cardiac applications with exceptional energy metabolism support, bioavailability, and reproducibility across diverse therapeutic protocols.

Cardiac Performance

ATP regeneration: Direct phosphocreatine pathway activation

Optimal for myocardial energy metabolism
Dissolution Rate

Solubility: Rapid dissolution in physiological media

Immediate bioavailability upon injection
Stability Profile

Chemical stability: Excellent in aqueous solutions

Maintains potency during storage
Thermal Stability

Decomposition temperature: >200°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.5% between batches

Consistent therapeutic efficacy
Shelf Stability

3 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Generally safe for pharmaceutical use when handled properly. Non-toxic at therapeutic doses. Handle with standard pharmaceutical safety precautions and ensure proper aseptic technique for injectable formulations. Minimal safety concerns for trained pharmaceutical personnel.

Low Toxicity
Pharmaceutical Safe
Professional Use

Storage & Handling

Store in original containers in a cool, dry, well-ventilated area away from moisture and light. Keep containers tightly closed and maintain pharmaceutical-grade environmental controls. Use appropriate aseptic handling techniques for injectable formulations.

Cool storage (15-25°C)
Protect from moisture
Protect from light
Aseptic handling required

Chemical Mechanisms & Reaction Pathways

Creatine Phosphate Disodium Salt exhibits cardioprotective properties through cellular energy metabolism enhancement, enabling predictable therapeutic response with well-characterized biochemical pathways.

Mechanism of Action

ATP regeneration via creatine kinase pathway

Cellular energy metabolism support
Metabolic Pathway

Phosphocreatine system for rapid ATP resynthesis

Myocardial energy preservation
Pharmacokinetics

Intravenous administration with tissue uptake

Rapid myocardial distribution
Elimination

Metabolic conversion to creatinine

Renal excretion pathway

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 Creatine Phosphate Disodium Salt 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 Creatine Phosphate Disodium Salt 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 Creatine Phosphate Disodium Salt 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 Creatine Phosphate Disodium Salt effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Formulations
Bioavailability: Intravenous administration Half-life: Rapid tissue uptake Stability: 3+ years refrigerated storage
Clinical Applications
Efficacy: Improved cardiac function Safety: Well-tolerated profile Dosage: 1-2g IV for cardiac protection
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