Finerenone USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Finerenone USP/EP

High-purity pharmaceutical grade Finerenone manufactured under stringent cGMP conditions. This mineralocorticoid receptor antagonist API is essential for endocrine-based therapy, particularly in chronic kidney disease and diabetic nephropathy treatment, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Mineralocorticoid Receptor Antagonist
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C21H22N4O3
CAS Number: 726169-73-9
Molecular Weight: 378.43 g/mol
Purity (HPLC): ≥99.0% (pharmaceutical grade)
Physical State: White to off-white crystalline powder
Water Content (Karl Fischer): ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% total impurities
Storage Conditions: Store in cool, dry place (15-25°C)
Packaging Options: 100g, 500g pharmaceutical containers

Applications

Mineralocorticoid Receptor Antagonist Manufacturing
Kidney Disease Treatment Formulations
Diabetic Nephropathy Products
API Synthesis & Development
Endocrine Research Applications
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 Finerenone grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse kidney disease treatment and endocrine therapy drug manufacturing applications.

USP Grade (Pharmaceutical)
Purity: ≥99.0% (HPLC) Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (pharmaceutical) Related Substances: ≤1.0% Residue on Ignition: ≤0.1% Application: European market compliance
Research Grade
Purity: ≥98.0% (analytical) Water Content: ≤1.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.5% (pharmaceutical) Endotoxins: ≤2.5 EU/mg Microbial Limits: Compliant Application: Nephrology formulations

Quality Standards

DRAVYOM's pharmaceutical grade Finerenone 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
≥99.0% 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 Finerenone exhibits exceptional chemical properties essential for mineralocorticoid receptor antagonist applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Slightly soluble
LogP (octanol/water): 2.49
pKa: 4.2
Molecular Weight: 378.35 g/mol
Physical Properties
Appearance: White to off-white crystalline powder
Melting Point: 195-197°C
Bulk Density: 0.5-0.7 g/mL
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Bioavailability: 44% (oral)
Protein Binding: 92%
Half-life: 2-3 hours
Mechanism: MR antagonist
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤1.0% total
Water Content: ≤1.0% (Karl Fischer)
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 conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Finerenone superiority in nephrology applications with exceptional mineralocorticoid receptor antagonism, cardiovascular protection, and reproducibility across diverse therapeutic protocols.

MR Selectivity

Selective mineralocorticoid receptor antagonism

Minimal hormonal effects
Renal Protection

Effective renal protective effects

Reduces proteinuria
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 195-197°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.1% between batches

Consistent therapeutic efficacy
Cardiovascular Benefits

Cardiovascular protective effects

Reduces CV events

Safety Information

Pharmaceutical ingredient requiring professional handling protocols. Well-established safety profile for nephrology applications. Handle with appropriate pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring for hyperkalemia and renal function during therapeutic use.

Pharmaceutical Grade
Professional Use
Monitor renal function

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 GMP handling techniques for API processing.

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

Chemical Mechanisms & Reaction Pathways

Finerenone exhibits selective mineralocorticoid receptor antagonism through competitive aldosterone binding, providing cardio-renal protection in patients with chronic kidney disease and type 2 diabetes.

MR Antagonism

Selective mineralocorticoid receptor competitive inhibition

Blocks aldosterone signaling pathway
Cardio-Renal Protection

Reduces inflammation and fibrosis in heart and kidneys

Prevents organ damage progression
Selective Activity

High selectivity for mineralocorticoid receptors

Reduced potassium elevation risk
Novel Mechanism

Non-steroidal mineralocorticoid receptor antagonist

Improved safety profile

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures endocrine pharmaceutical manufacturing access with complete documentation packages supporting international standards and cardio-renal therapy development.

USP Standards

United States Pharmacopeia endocrine drug specifications

EP Monograph

European Pharmacopoeia specifications for MR antagonists

Endocrine GMP

Specialized GMP for endocrine drug manufacturing

ICH Guidelines

International endocrine drug development regulatory compliance

Endocrine DMF

Drug Master File for endocrine applications

Safety Documentation

Comprehensive endocrine safety and pharmacovigilance documentation

Technical Support & Value-Added Services

DRAVYOM's endocrine pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Finerenone cardio-renal protection applications.

Endocrine Formulation
  • MR antagonist formulation optimization
  • Tablet development for chronic kidney disease
  • Bioavailability enhancement
  • Custom endocrine development
Analytical Services
  • API purity and potency analysis
  • Endocrine impurity profiling
  • Stability testing protocols
  • Method validation support
Regulatory Support
  • Endocrine regulatory filing
  • DMF preparation and maintenance
  • International compliance guidance
  • Endocrine pharmacovigilance
Supply Solutions
  • Endocrine pharmaceutical supply chain
  • Custom packaging solutions
  • Global distribution network
  • Emergency endocrine supply

Environmental Impact & Sustainability

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

Green Chemistry

Environmentally friendly synthesis and processing methods

Water Conservation

Advanced water treatment and recycling systems

Clean Production

Energy-efficient pharmaceutical manufacturing processes

Waste Reduction

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Sourcing

Responsible procurement of pharmaceutical raw materials

Manufacturing Excellence & Quality Control

DRAVYOM's pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Finerenone quality and cardio-renal therapeutic performance.

Pharmaceutical GMP

Advanced manufacturing in controlled clean-room environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive testing including assay, impurities, and stability

HPLC verification and endocrine analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and pharmaceutical validation
Pharmaceutical Packaging

Pharmaceutical-grade containers with moisture protection

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive cardio-renal data demonstrating Finerenone effectiveness in chronic kidney disease with quantified performance metrics and clinical validation data.

Endocrine Formulations
Bioavailability: 44% oral bioavailability Stability: 3-year shelf life validated Compatibility: Excellent with tablet excipients
Therapeutic Applications
CKD: Proven chronic kidney disease treatment Diabetes: Effective diabetic nephropathy therapy Safety: Selective MR antagonist profile
Manufacturing Performance
Yield: 93% pharmaceutical grade recovery Purity: >99.0% pharmaceutical specification Consistency: 99.6% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Endocrine Excellence

Superior pharmaceutical grade with proven MR selectivity and regulatory compliance

Reliable Supply

Guaranteed endocrine supply with strategic inventory management and specialized production

Cardio-Renal Expertise

Dedicated cardio-renal development team with specialized endocrine formulation support

Regulatory Compliance

Complete endocrine documentation with DMF support and international compliance

Global Standards

International pharmaceutical compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative endocrine relationships with specialized development services