Vildagliptin
Pharmaceutical Premium
Pharmaceutical API

Vildagliptin

High-purity pharmaceutical grade Vildagliptin 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: C17H25N3O2
CAS Number: 274901-16-5
Molecular Weight: 303.40 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% (total impurities)
Particle Size: D90 ≤ 100 μm
pH (1% solution): 5.0-7.0
Solubility: Freely soluble in water
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

Diabetes Management
Oral Tablet Formulations
Capsule Formulations
DPP-4 Inhibitor
Type 2 Diabetes Treatment
Endocrine Therapy
Antidiabetic Medications
Glucose Control
Diabetes Research
Generic Formulations
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Vildagliptin grades tailored for specific diabetes management pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse antidiabetic 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) Loss on Drying: ≤0.5% pH: 5.0-7.0 (1% solution) Application: EU regulatory submissions
Antidiabetic Grade
Purity: ≥99.5% (HPLC) DPP-4 Activity: Verified Bioavailability: Optimized Application: Diabetes medications
Generic Grade
Purity: ≥99.8% (HPLC) Dissolution Profile: Matched Stability: Verified Application: Generic formulations

Quality Standards

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

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Diabetes Testing
DPP-4 Activity Verified
Batch-to-Batch Consistency
Comprehensive COA
Pharmaceutical Grade Packaging

Advanced Chemical Properties & Performance

Pharmaceutical Grade Vildagliptin exhibits exceptional chemical properties essential for diabetes applications. Its DPP-4 inhibitor composition and precise specification ensure reliable performance in demanding pharmaceutical formulations and endocrine treatment systems.

Chemical Properties
Molecular Formula: C₁₇H₂₅N₃O₂
Molecular Weight: 303.40 g/mol
Melting Point: 150-152°C
LogP (Octanol/Water): 1.3
Physical Properties
Appearance: White to off-white crystalline powder
Solubility: Freely soluble in water
pH (1% solution): 7.5-8.5
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Bioavailability: 85% (oral)
Half-life: 2-3 hours
Protein Binding: 9.3%
Mechanism: DPP-4 enzyme inhibitor
Purity Specifications
Assay (HPLC): ≥ 99.0%
Related Substances: ≤ 0.5%
Heavy Metals: ≤ 20 ppm
Residual Solvents: Within ICH limits
Stability Properties
Shelf Life: 3 years (unopened)
Photostability: Stable under normal light
Temperature Stability: Stable 15-25°C
Humidity Stability: Store ≤60% RH

Performance Characteristics

Detailed performance metrics demonstrate Pharmaceutical Grade Vildagliptin superiority in antidiabetic applications with exceptional functionality, stability, and reproducibility across diverse pharmaceutical procedures and endocrine protocols.

Antidiabetic Efficacy

Potency: Selective DPP-4 enzyme inhibitor

Superior glucose control
Duration of Action

Time: 12-hour therapeutic effect

Twice-daily dosing flexibility
Bioavailability

Absorption: 85% oral bioavailability

Excellent therapeutic levels
Formulation Stability

Range: Stable in standard formulations

Consistent performance across dosage forms
Batch Uniformity

Variation: ±0.5% between production batches

Exceptional pharmaceutical grade consistency
Long-term Stability

3 years shelf life with maintained potency

Extended pharmaceutical grade integrity

Safety Information

Prescription pharmaceutical with established safety profile in diabetes therapy. Generally well-tolerated antidiabetic agent requiring glucose monitoring. Handle with standard laboratory precautions including appropriate protective equipment. Avoid inhalation of powder and ensure proper ventilation during processing.

Prescription Only
Diabetes Active
Medical Supervision

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 degradation. Use appropriate pharmaceutical handling procedures and ensure proper environmental controls for stability management.

Cool storage (15-25°C)
Low humidity (≤60% RH)
Normal light exposure acceptable
Original sealed containers

Chemical Mechanisms & Reaction Pathways

Pharmaceutical Grade Vildagliptin exhibits selective DPP-4 inhibitor properties through cyanopyrrolidine structure enabling effective glycemic control with preservation of pancreatic beta-cell function and minimal hypoglycemia risk.

DPP-4 Inhibition

Selective inhibition of dipeptidyl peptidase-4 enzyme

Prolongs incretin hormone activity and glucose homeostasis
Incretin Enhancement

Increases active GLP-1 and GIP hormone levels

Glucose-dependent insulin secretion and glucagon suppression
Beta-Cell Protection

Preservation of pancreatic beta-cell mass and function

Long-term diabetes progression prevention
Safety Profile

Minimal hypoglycemia risk and weight neutrality

Excellent tolerability in diabetic patients

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete API documentation supporting international standards and antidiabetic drug manufacturing validations.

USP Specifications

United States Pharmacopeia API standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical manufacturing

FDA Approved

FDA approved antidiabetic API with comprehensive safety data

EMA Approval

European Medicines Agency approval for diabetes applications

DMF Documentation

Drug Master File with comprehensive manufacturing and safety data

cGMP Certified

Current Good Manufacturing Practice with diabetes API standards

Technical Support & Value-Added Services

DRAVYOM's endocrinology API team provides comprehensive development support, formulation optimization assistance, and regulatory services for antidiabetic drug manufacturing with specialized diabetes expertise.

API Development
  • Diabetes formulation support
  • Bioavailability enhancement studies
  • Stability optimization protocols
  • Fixed-dose combination development
Analytical Services
  • Certificate of Analysis with diabetes testing
  • Polymorphic form characterization
  • Impurity profiling and identification
  • Dissolution study support
Regulatory Support
  • Diabetes drug documentation
  • Regulatory filing assistance
  • Clinical trial support
  • Post-market surveillance
Supply Solutions
  • Consistent API supply chains
  • Temperature-controlled logistics
  • Emergency supply protocols
  • Global distribution network

Environmental Impact & Sustainability

Our Pharmaceutical Grade Vildagliptin production emphasizes environmental responsibility through green chemistry principles, sustainable synthetic pathways, and comprehensive environmental impact management for API manufacturing.

Green Synthesis

Optimized synthetic routes with minimal environmental impact

Solvent Recovery

Advanced solvent recycling and waste minimization

Clean Production

Energy-efficient synthesis with emission controls

Water Treatment

Advanced wastewater treatment and recycling systems

ISO 14001

Environmental management system certified production

Carbon Reduction

Continuous carbon footprint reduction initiatives

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art endocrinology API manufacturing facility employs advanced synthetic technology and continuous monitoring systems to ensure consistent Pharmaceutical Grade Vildagliptin quality and therapeutic efficacy.

Production Process

Advanced multi-step synthesis with pharmaceutical-grade intermediates

Controlled synthesis for optimal purity and yield
Quality Testing

25-point pharmaceutical testing protocol including stereochemical analysis

HPLC verification and diabetes-specific testing
Quality Systems

cGMP compliance with diabetes API manufacturing standards

Continuous improvement and process validation
API Packaging

Specialized packaging with moisture and light protection

Stability maintenance and contamination prevention

Market Applications & Performance Data

Comprehensive clinical and pharmaceutical data demonstrating Pharmaceutical Grade Vildagliptin effectiveness across diverse diabetes applications with quantified glycemic control metrics and safety profiles.

Type 2 Diabetes
HbA1c Reduction: 0.6-1.1% reduction from baseline Fasting Glucose: 20-30 mg/dL improvement Response Rate: 60-70% achieve glycemic targets
Safety Profile
Hypoglycemia: Very low risk when used as monotherapy Weight: Weight neutral or modest reduction Tolerability: Excellent with minimal GI effects
Combination Therapy
Metformin: Synergistic glucose control Insulin: Reduced insulin requirements Sulfonylureas: Enhanced efficacy with reduced hypoglycemia

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmacopeial specifications with optimal stereochemical control and impurity profile

Reliable Supply

Guaranteed availability with strategic inventory management and diabetes API expertise

API Expertise

Specialized diabetes API manufacturing with comprehensive DPP-4 inhibitor development support

Quality Assurance

Enhanced testing protocols with complete documentation and regulatory compliance

Global Standards

International compliance with USP, EP, and diabetes drug regulations worldwide

Partnership Approach

Collaborative relationships with endocrinology pharmaceutical companies and development support