Teneligliptin
Pharmaceutical Premium
Pharmaceutical API

Teneligliptin

High-purity pharmaceutical grade Teneligliptin 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: C22H30N6O2
CAS Number: 426877-23-6
Molecular Weight: 410.52 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: Slightly 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 Teneligliptin 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
Immediate Release Grade
Purity: ≥99.8% (HPLC) Dissolution Rate: Verified Particle Size: Controlled Application: Immediate release tablets

Quality Standards

DRAVYOM's Teneligliptin 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 Teneligliptin exhibits exceptional chemical properties essential for antidiabetic applications. Its DPP-4 inhibitor composition and precise specification ensure reliable performance in demanding pharmaceutical formulations and diabetes management systems.

Chemical Properties
Molecular Formula: C₂₂H₃₀N₆O₂
Molecular Weight: 426.52 g/mol
Melting Point: 200-205°C
LogP (Octanol/Water): 2.1
Physical Properties
Appearance: White to off-white crystalline powder
Solubility: Sparingly soluble in water
pH (1% solution): 6.0-8.0
Bulk Density: 0.5-0.7 g/cm³
Pharmaceutical Performance
Bioavailability: 79% (oral)
Half-life: 24 hours
Protein Binding: 67%
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 Teneligliptin superiority in antidiabetic applications with exceptional functionality, stability, and reproducibility across diverse pharmaceutical procedures and diabetes management protocols.

Glycemic Control

Efficacy: Significant HbA1c reduction

Superior diabetes management
Duration of Action

Time: 24-hour therapeutic coverage

Once-daily dosing convenience
Bioavailability

Absorption: 79% 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 excellent safety profile. Well-tolerated antidiabetic agent with low hypoglycemia risk. Handle with standard laboratory precautions including appropriate protective equipment. Avoid inhalation of powder and ensure proper ventilation during processing.

Prescription Only
Well Tolerated
Low Hypoglycemia Risk

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)
Original sealed containers
Protect from direct sunlight

Chemical Mechanisms & Reaction Pathways

Pharmaceutical Grade Teneligliptin exhibits selective DPP-4 inhibition through pyrrolidine structure enabling effective diabetes management with unique pharmacological characteristics and glucose-dependent mechanisms.

DPP-4 Inhibition

Selective inhibition of dipeptidyl peptidase-4 enzyme

Enhances incretin hormone activity for glucose control
Glucose Regulation

Glucose-dependent insulin secretion enhancement

Reduces hyperglycemia without hypoglycemia risk
Pancreatic Protection

Beta-cell preservation and alpha-cell modulation

Long-term pancreatic function maintenance
Renal Safety

Minimal renal metabolism with excellent safety profile

Safe for patients with renal impairment

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete API documentation supporting international standards and diabetes 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 diabetes API team provides comprehensive development support, formulation optimization assistance, and regulatory services for antidiabetic drug manufacturing with specialized endocrine expertise.

API Development
  • Diabetes formulation support
  • Bioavailability enhancement studies
  • Stability optimization protocols
  • Combination therapy development
Analytical Services
  • Certificate of Analysis with diabetes-specific 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 Teneligliptin 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 Neutral

Carbon-neutral production with renewable energy

Manufacturing Excellence & Quality Control

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

Production Process

Advanced multi-step synthesis with pharmaceutical-grade intermediates

Controlled synthesis for optimal purity and yield
Quality Testing

32-point pharmaceutical testing protocol including polymorphic 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 Teneligliptin effectiveness across diverse diabetes applications with quantified therapeutic metrics and safety profiles.

Type 2 Diabetes
HbA1c Reduction: 0.6-1.0% average decrease Onset: 1-2 hours therapeutic effect Duration: 24-hour glycemic control
Safety Profile
Hypoglycemia: Minimal risk profile Weight Neutral: No significant weight changes Renal Safety: Safe in kidney impairment
Combination Therapy
Metformin: Enhanced glycemic control Insulin: Reduced insulin requirements Sulfonylureas: Synergistic effects

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmacopeial specifications with optimal polymorphic control and impurity profile

Reliable Supply

Guaranteed availability with strategic inventory management and diabetes API expertise

API Expertise

Specialized diabetes API manufacturing with comprehensive 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 diabetes pharmaceutical companies and development support