Empagliflozin
Pharmaceutical Premium
Pharmaceutical API

Empagliflozin

High-purity pharmaceutical grade Empagliflozin manufactured to meet stringent USP/EP specifications for pharmaceutical formulations and research applications. Our pharmaceutical grade material delivers exceptional purity and consistency for critical pharmaceutical manufacturing.

  • USP/EP Grade Specifications
  • High Purity (≥99.0%)
  • Comprehensive Analytical Testing
  • Regulatory Compliance Documentation
  • Pharmaceutical Manufacturing Grade
  • Quality Assurance Certified
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Technical Specifications

Chemical Formula: C23H27ClO7
CAS Number: 864070-44-0
Molecular Weight: 450.91 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 (15-30°C)
Packaging Options: 100g, 500g pharmaceutical containers

Applications

Diabetes Drug Manufacturing
SGLT2 Inhibitor Formulations
Oral Pharmaceutical Products
API Synthesis & Development
Type 2 Diabetes Treatment
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 Empagliflozin grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse antidiabetic 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: Diabetes formulations

Quality Standards

DRAVYOM's pharmaceutical grade Empagliflozin 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
Comprehensive Impurity Control
Batch-to-Batch Consistency
Complete Documentation Package
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Empagliflozin exhibits exceptional chemical properties essential for diabetes 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): 2.15
pKa: 12.1
Molecular Weight: 450.91 g/mol
Physical Properties
Appearance: White to off-white crystalline powder
Melting Point: 176-178°C
Bulk Density: 0.5-0.7 g/mL
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
Bioavailability: 78% (oral)
Protein Binding: 86%
Half-life: 12.4 hours
Mechanism: SGLT2 inhibitor
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤0.5% total
Water Content: ≤0.5% (Karl Fischer)
Residue on Ignition: ≤0.1%
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 Empagliflozin superiority in diabetes applications with exceptional SGLT2 inhibition, glucose control, and reproducibility across diverse therapeutic protocols.

SGLT2 Inhibition

Selective sodium-glucose co-transporter 2 inhibition

Reduces glucose reabsorption
Cardiovascular Benefits

Reduces cardiovascular events

Heart failure protection
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 176-178°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.2% between batches

Consistent therapeutic efficacy
Once-Daily Dosing

12.4-hour half-life for convenient dosing

Improved patient compliance

Safety Information

Prescription pharmaceutical ingredient requiring professional handling. Well-established safety profile for diabetes therapy. Handle with pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring for ketoacidosis and renal function during therapeutic use.

Prescription Only
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 (hygroscopic)
Protect from light
GMP handling required

Chemical Mechanisms & Reaction Pathways

Empagliflozin exhibits SGLT2 inhibition properties through selective glucose transporter blockade in the kidneys, reducing glucose reabsorption and promoting glucosuria for diabetes management and cardiovascular protection.

SGLT2 Inhibition

Selective inhibition of sodium-glucose transporter 2

Reduces renal glucose reabsorption
Glucosuria Induction

Promotes glucose excretion through urine

Lowers blood glucose levels
Cardiovascular Benefits

Provides cardioprotective effects beyond glycemic control

Reduces cardiovascular mortality
Renal Protection

Preserves kidney function in diabetic patients

Slows diabetic nephropathy progression

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures diabetes pharmaceutical manufacturing access with complete documentation packages supporting international standards and antidiabetic drug development.

USP Standards

United States Pharmacopeia diabetes drug specifications

EP Monograph

European Pharmacopoeia specifications for SGLT2 inhibitors

Diabetes GMP

Specialized GMP for diabetes drug manufacturing

ICH Guidelines

International diabetes drug development regulatory compliance

Diabetes DMF

Drug Master File for diabetes applications

Safety Documentation

Comprehensive diabetes safety and pharmacovigilance documentation

Technical Support & Value-Added Services

DRAVYOM's diabetes pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Empagliflozin diabetes applications.

Diabetes Formulation
  • Diabetes formulation optimization
  • Bioavailability enhancement
  • Tablet formulation development
  • Custom diabetes development
Analytical Services
  • API purity and potency analysis
  • Diabetes impurity profiling
  • Stability testing protocols
  • Method validation support
Regulatory Support
  • Diabetes regulatory filing
  • DMF preparation and maintenance
  • International compliance guidance
  • Pharmacovigilance support
Supply Solutions
  • Diabetes pharmaceutical supply chain
  • Custom packaging solutions
  • Global distribution network
  • Emergency supply arrangements

Environmental Impact & Sustainability

Our Empagliflozin 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 Empagliflozin quality and diabetes therapeutic performance.

Controlled Production

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 diabetes analysis
Quality Systems

ISO 9001:2015 quality management with diabetes compliance

Continuous improvement and diabetes validation
Pharmaceutical Packaging

Pharmaceutical-grade containers with moisture protection

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive diabetes data demonstrating Empagliflozin effectiveness in diabetes management with quantified performance metrics and clinical validation data.

Diabetes Formulations
Bioavailability: 78% oral bioavailability Stability: 3-year shelf life validated Compatibility: Excellent with tablet excipients
Therapeutic Applications
Diabetes: Proven glycemic control Cardiovascular: Cardiovascular mortality reduction Renal: Kidney protection benefits
Manufacturing Performance
Yield: 97% pharmaceutical grade recovery Purity: >99.5% diabetes specification Consistency: 99.8% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Diabetes Excellence

Superior diabetes pharmaceutical grade with proven therapeutic performance and regulatory compliance

Reliable Supply

Guaranteed availability with strategic inventory management and diabetes production scheduling

Formulation Expertise

Dedicated diabetes pharmaceutical development team with specialized formulation support

Regulatory Compliance

Complete diabetes documentation with DMF support and international compliance

Global Standards

International diabetes compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative diabetes relationships with specialized development services