Ursodeoxycholic Acid USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Ursodeoxycholic Acid USP/EP

High-purity pharmaceutical grade Ursodeoxycholic Acid manufactured under stringent cGMP conditions. This bile acid API is essential for cholelithiasis treatment, particularly in gallstone dissolution and primary biliary cholangitis, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Bile Acid for Gallstone Treatment
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C24H40O4
CAS Number: 128-13-2
EINECS Number: 204-879-3
Molecular Weight: 392.57 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 203-204°C
Optical Rotation: +59° to +63° (c=1, ethanol)
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% (total impurities)
Storage Conditions: Store at room temperature, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 25g, 50g, 100g pharmaceutical containers

Applications

Oral Tablet Formulations
Capsule Formulations
Gallstone Dissolution
Primary Biliary Cholangitis
Hepatology Research
Gastroenterology Units
Bile Acid Therapy
Cholelithiasis Treatment
Hepatic Studies
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Ursodeoxycholic Acid grades tailored for specific hepatic pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse gallstone and liver disease therapeutic applications.

USP Grade (United States Pharmacopeia)
Purity: ≥99.0% (HPLC) Related Substances: ≤1.0% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (HPLC) Optical Rotation: +59° to +63° Loss on Drying: ≤0.5% Application: EU regulatory submissions
Hepatology Research Grade
Purity: ≥99.5% (HPLC) Water Content: ≤0.2% Residue on Ignition: ≤0.05% Application: Bile acid research
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

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

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Bile Acid Testing
Hepatology Grade Quality
Batch-to-Batch Consistency
Comprehensive COA
Pharmaceutical Grade Packaging

Advanced Chemical Properties & Performance

Ursodeoxycholic Acid exhibits exceptional bile acid properties essential for hepatic applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding liver treatment formulations.

Molecular Properties
Molecular Weight: 392.57 g/mol
LogP: 2.85
pKa: 5.02
Bioavailability: 95%
Physical Properties
Melting Point: 200-204°C
Solubility (Water): 0.2 mg/mL
Crystalline Form: Stable polymorph
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Hepatoprotective Effect: Significant
Bile Acid Modulation: Effective
Selectivity: Liver-specific
Stability: Stable in solid state
Purity Specifications
Assay: ≥99.0%
Related Substances: ≤0.5%
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable at room temperature
pH Stability: Stable pH 4-7

Performance Characteristics

Detailed performance metrics demonstrate Ursodeoxycholic Acid superiority in hepatic applications with exceptional bile acid modulation, bioavailability, and reproducibility across diverse liver treatment formulations.

Hepatoprotective Effect

EC50: 25-30 μM for hepatocytes

Significant liver protection
Bioavailability

Oral: 95% absolute bioavailability

Excellent drug absorption
Stability

Solid state: >5 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 15-40°C processing

Stable during formulation
Batch Reproducibility

Variation: ±0.5% between batches

Consistent lot-to-lot performance
Shelf Stability

5 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade bile acid requiring careful handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for bile acid APIs and ensure proper waste disposal procedures.

Pharmaceutical API
Avoid Skin Contact
Avoid Inhalation

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from light and moisture. Keep containers tightly closed and protect from direct sunlight. Use appropriate containment measures for pharmaceutical API handling.

Cool storage (2-8°C)
Protect from light
Original sealed containers
Pharmaceutical containment required

Chemical Mechanisms & Reaction Pathways

Ursodeoxycholic Acid functions as a cytoprotective bile acid through membrane stabilization and bile acid pool modification, enabling hepatoprotective effects with well-characterized choleretic pathways and cellular protection mechanisms.

Bile Acid Displacement

Displacement of toxic hydrophobic bile acids from bile acid pool

Reduces hepatotoxic bile acid levels
Membrane Stabilization

Direct stabilization of hepatocyte and cholangiocyte cell membranes

Prevents apoptosis and cellular damage
Choleretic Action

Stimulation of bile flow through enhanced bicarbonate secretion

Improves bile acid-dependent flow
Therapeutic Action

Hepatoprotection in cholestatic liver diseases and gallstone dissolution

Reduces liver enzyme elevations

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical manufacturing access with complete documentation packages supporting international standards and pharmaceutical development requirements.

USP/EP Standards

United States Pharmacopeia and European Pharmacopoeia compliance

ICH Guidelines

International Conference on Harmonisation pharmaceutical standards

cGMP Manufacturing

Current Good Manufacturing Practice certified production

Global Registration

DMF filings and regulatory support for worldwide markets

Stability Studies

Long-term and accelerated stability data packages

Impurity Profiling

Comprehensive impurity identification and qualification

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory assistance to optimize pharmaceutical manufacturing processes and ensure successful product development.

Formulation Development
  • API compatibility studies
  • Excipient interaction analysis
  • Stability-indicating method development
  • Formulation optimization support
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Forced degradation studies
  • Bioanalytical method development
Technical Support
  • Pharmaceutical development consultation
  • Manufacturing process optimization
  • Quality system implementation
  • Regulatory filing support
Supply Solutions
  • Clinical trial material supply
  • Commercial scale manufacturing
  • Just-in-time delivery programs
  • Global supply chain management

Environmental Impact & Sustainability

Our pharmaceutical API production emphasizes environmental responsibility through sustainable manufacturing practices, waste minimization, and comprehensive environmental impact management for pharmaceutical operations.

Green Chemistry

Optimized synthetic routes with minimal environmental impact

Solvent Recovery

Advanced solvent recovery and recycling systems

Energy Efficiency

Renewable energy integration in manufacturing processes

Waste Management

Comprehensive pharmaceutical waste treatment protocols

ISO 14001

Environmental management system certified operations

Packaging Innovation

Sustainable packaging materials and design optimization

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced process control technology and comprehensive quality systems to ensure consistent API quality and performance across all production batches.

cGMP Manufacturing

Current Good Manufacturing Practice compliant production in controlled environments

FDA and EMA inspected pharmaceutical facilities
Quality Control

Multi-point quality control testing including assay, related substances, and residual solvents

HPLC, GC-MS, and NMR analytical verification
Quality Systems

ISO 9001:2015 quality management with pharmaceutical quality system standards

Continuous improvement and change control procedures
Packaging Systems

Primary packaging in controlled atmosphere with tamper-evident sealing

Light protection and moisture barrier packaging

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating API effectiveness across diverse therapeutic applications with quantified performance metrics and regulatory validation studies.

Pharmaceutical Manufacturing
Purity: >99.5% pharmaceutical grade Stability: 36-month shelf life data Compliance: 100% regulatory specifications
Research & Development
Research Support: 200+ published studies Method Validation: Cross-platform verification Innovation: Advanced analytical techniques
Clinical Applications
Clinical Grade: Phase I-III trial supply Regulatory Success: Global market approvals Manufacturing: Scalable production processes

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with exceptional purity and pharmaceutical performance standards

Reliable Supply Chain

Guaranteed pharmaceutical-grade availability with strategic inventory management and production scheduling

Development Expertise

Dedicated pharmaceutical development team provides formulation and analytical method support

Regulatory Excellence

Comprehensive documentation packages with global regulatory filing support and validation

Global Standards

International compliance with USP, EP, JP, and ICH guidelines for worldwide pharmaceutical acceptance

Partnership Excellence

Collaborative pharmaceutical development relationships with custom API synthesis and scale-up services