Sitagliptin
Pharmaceutical Premium
Pharmaceutical API

Sitagliptin

High-purity pharmaceutical grade Sitagliptin 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: C16H15F6N5O
CAS Number: 486460-32-6
EINECS Number: Not available
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white crystalline powder
Molecular Weight: 407.31 g/mol
Melting Point: 189-193°C
pH (1% solution): 5.5-7.5
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Sparingly soluble in water
Storage Conditions: Store at 15-30°C, protect from moisture
Shelf Life: 3 years from manufacture date
Packaging Options: 100g, 500g, 1kg containers

Applications

Type 2 Diabetes
DPP-4 Inhibitor
Oral Tablet Formulations
Glycemic Control
Endocrine Therapy
Diabetes Management
Metabolic Disorders
Blood Glucose Control
Diabetes Research
Antidiabetic Formulations
API Manufacturing
Pharmaceutical Research

Industry-Specific Grades

DRAVYOM offers specialized Sitagliptin grades tailored for specific diabetes applications, ensuring optimal DPP-4 inhibition and regulatory compliance across diverse pharmaceutical formulations.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% Related Substances: ≤1.0% Residual Solvents: EP limits Application: European market compliance
Research Grade
Purity: ≥98.0% Activity: Verified Stability: Enhanced Application: Diabetes research
Antidiabetic Grade
Purity: ≥99.5% DPP-4 Inhibition: Optimized Bioavailability: Enhanced Application: Diabetes therapy

Quality Standards

DRAVYOM's Sitagliptin is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and FDA guidelines for diabetes therapy applications.

cGMP Manufacturing Standards
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
DPP-4 Activity Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Controlled Storage & Shipping

Advanced Chemical Properties & Performance

Pharmaceutical Grade Sitagliptin exhibits exceptional chemical properties essential for diabetes management applications. Its potent DPP-4 inhibitor structure and superior stability characteristics ensure reliable performance in demanding antidiabetic formulations.

Molecular Properties
Molecular Weight: 407.31 g/mol
Molecular Formula: C16H15F6N5O
LogP (Octanol/Water): 1.6
pKa: 8.9
Physical Properties
Melting Point: 203-208°C
Appearance: White to off-white crystalline powder
Solubility (Water): Slightly soluble
Bulk Density: 0.50-0.60 g/cm³
Pharmaceutical Properties
Bioavailability: 87%
Protein Binding: 38%
Half-life: 12.4 hours
Mechanism: DPP-4 enzyme inhibition
Quality Specifications
Purity (HPLC): ≥99.0%
Water Content: ≤0.5%
Related Substances: ≤1.0%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-25°C
Light Sensitivity: Store in light-resistant containers
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate Sitagliptin superiority in diabetes management applications with exceptional DPP-4 inhibition, glucose-dependent insulin release, and therapeutic efficacy across diverse type 2 diabetes treatment protocols.

DPP-4 Inhibition

Selective and potent DPP-4 enzyme inhibition

Enhanced incretin hormone levels
Glucose Control

Effective glucose-dependent insulin release

Improved glycemic control
Beta Cell Protection

Pancreatic beta cell preservation

Long-term diabetes management
Extended Half-life

12.4-hour elimination half-life

Once-daily dosing convenience
Clinical Efficacy

FDA-approved for type 2 diabetes

Proven antidiabetic benefits
Weight Neutral

No significant weight gain

Metabolic advantage

Safety Information

Pharmaceutical active ingredient requiring careful handling protocols. Handle in controlled environments with appropriate ventilation systems. Use proper personal protective equipment and follow established safety protocols for antidiabetic compounds.

Active Pharmaceutical Ingredient
Controlled Handling Required
Standard PPE Required

Storage & Handling

Store in tightly closed, light-resistant containers in a cool, dry place away from direct sunlight. Maintain controlled room temperature storage and ensure protection from moisture and humidity to preserve pharmaceutical quality and antidiabetic potency.

Controlled room temperature (15-25°C)
Protect from light
Light-resistant containers
Store in dry conditions

Chemical Mechanisms & Reaction Pathways

Sitagliptin exhibits specific dipeptidyl peptidase-4 (DPP-4) inhibitor mechanisms essential for type 2 diabetes treatment. Its molecular structure enables selective enzyme inhibition with predictable antidiabetic therapeutic responses.

DPP-4 Inhibition

Selective and reversible DPP-4 enzyme inhibition mechanism

Enhanced incretin hormone levels
Metabolic Pathways

Limited hepatic metabolism with predominantly renal excretion

Minimal drug-drug interactions
Glucose Regulation

Glucose-dependent insulin secretion and glucagon suppression

Improved glycemic control
Antidiabetic Effects

Reduced HbA1c and postprandial glucose levels

Type 2 diabetes management

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia pharmaceutical standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical quality

ICH Guidelines

International Conference on Harmonization standards compliance

GMP Certification

Good Manufacturing Practices certified production facility

DMF Support

Drug Master File documentation for regulatory submissions

CEP Available

Certificate of Suitability to European Pharmacopoeia monographs

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, regulatory assistance, and technical services to optimize pharmaceutical performance in your specific drug development applications.

Formulation Development
  • Dosage form optimization support
  • Stability testing guidance
  • Bioavailability enhancement
  • Custom formulation development
Analytical Services
  • Method development and validation
  • Impurity profiling and identification
  • Stability indicating methods
  • Dissolution testing support
Regulatory Support
  • Regulatory submission assistance
  • DMF preparation and maintenance
  • Pharmacovigilance support
  • Global registration strategy
Supply Solutions
  • Pharmaceutical supply chain management
  • Cold chain logistics
  • Custom packaging solutions
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical production emphasizes environmental responsibility through sustainable manufacturing practices, green chemistry principles, and comprehensive environmental impact management for pharmaceutical operations.

Green Chemistry

Sustainable synthetic routes with minimal environmental impact

Water Management

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Packaging

Recyclable pharmaceutical packaging solutions

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent pharmaceutical quality and performance across all production batches.

Production Process

Advanced synthesis and purification in GMP-controlled clean-room environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive testing protocol including purity, potency, and impurity profiling

HPLC, GC-MS, and spectroscopic analysis
Quality Systems

ISO 9001:2015 and GMP quality management systems

Continuous improvement and validation protocols
Packaging Control

Pharmaceutical-grade packaging with controlled atmosphere

Contamination prevention and stability protection

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation support.

Pharmaceutical Development
Formulation Success: 95+ formulations developed Regulatory Approvals: 100+ successful submissions Quality Consistency: 99.9% batch compliance
Research Applications
Clinical Studies: 200+ supported trials Publication Support: 150+ peer-reviewed papers Innovation: Custom API development
Commercial Manufacturing
Scale-up Success: 100% process transfers Supply Reliability: 99.8% on-time delivery Cost Optimization: 25% average cost reduction

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds pharmacopeial specifications with superior purity and pharmaceutical performance

Reliable Supply

Guaranteed pharmaceutical availability with strategic inventory and GMP production scheduling

Development Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Regulatory Assurance

Complete regulatory packages with DMF support and global registration assistance

Global Standards

International compliance with USP, EP, and ICH standards for worldwide market access

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services