Pioglitazone Hydrochloride
Pharmaceutical Premium
Pharmaceutical API

Pioglitazone Hydrochloride

High-purity pharmaceutical grade Pioglitazone Hydrochloride 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

Technical Specifications

Chemical Formula: C19H20N2O3S·HCl
CAS Number: 112529-15-4
EINECS Number: Not applicable
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white crystalline powder
Molecular Weight: 392.90 g/mol
Melting Point: 183-185°C
pH (1% solution): 2.5-4.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Slightly soluble in water
Storage Conditions: Store below 25°C, dry place
Shelf Life: 3 years from manufacture date
Packaging Options: 1kg, 5kg, 25kg drums

Applications

Type 2 Diabetes Treatment
Oral Tablet Formulations
PPAR-γ Agonist
Insulin Sensitizer
Cardiovascular Protection
Capsule Preparations
Metabolic Syndrome
Combination Therapy
Diabetes Research
Clinical Trials
Drug Development
Regulatory Studies

Industry-Specific Grades

DRAVYOM offers specialized Pioglitazone Hydrochloride grades tailored for specific antidiabetic applications, ensuring optimal PPAR-γ agonist efficacy and regulatory compliance across diverse diabetes treatment 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
Oral Formulation Grade
Purity: ≥99.5% Particle Size: Controlled Bioavailability: Optimized Application: Oral dosage forms

Quality Standards

DRAVYOM's Pioglitazone Hydrochloride is manufactured under stringent cGMP protocols, meeting international antidiabetic drug standards including USP, EP, and FDA guidelines for diabetes treatment applications.

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

Advanced Chemical Properties & Performance

Pharmaceutical Grade Pioglitazone Hydrochloride exhibits exceptional chemical properties essential for diabetes management applications. Its potent thiazolidinedione structure and superior stability characteristics ensure reliable performance in demanding antidiabetic formulations.

Molecular Properties
Molecular Weight: 392.90 g/mol
Molecular Formula: C19H21ClN2O3S
LogP (Octanol/Water): 3.8
pKa: 5.8, 6.2
Physical Properties
Melting Point: 183-185°C
Appearance: White to off-white crystalline powder
Solubility (Water): Freely soluble
Bulk Density: 0.45-0.55 g/cm³
Pharmaceutical Properties
Bioavailability: 83%
Protein Binding: 99.8%
Half-life: 16-24 hours
Mechanism: PPARγ receptor agonist
Quality Specifications
Purity (HPLC): ≥99.5%
Water Content: ≤0.5%
Related Substances: ≤0.5%
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 Pioglitazone Hydrochloride superiority in diabetes management applications with exceptional insulin sensitization, glucose control, and therapeutic efficacy across diverse type 2 diabetes treatment protocols.

PPARγ Activation

Potent peroxisome proliferator-activated receptor gamma agonism

Enhanced insulin sensitivity
Glucose Reduction

Significant reduction in fasting glucose levels

Improved glycemic control
Cardiovascular Benefits

Positive effects on cardiovascular risk factors

Reduced cardiovascular events
Extended Duration

16-24 hour elimination half-life

Once-daily dosing convenience
Clinical Efficacy

FDA-approved for type 2 diabetes mellitus

Proven antidiabetic benefits
Oral Bioavailability

High oral absorption and bioavailability

Patient-friendly administration

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

Pioglitazone hydrochloride functions as a selective PPARγ agonist with potent insulin sensitizing activity, providing effective glucose homeostasis through enhanced peripheral insulin sensitivity and reduced hepatic glucose production.

PPARγ Activation

Selective peroxisome proliferator-activated receptor gamma agonism

Enhanced insulin sensitivity
Glucose Metabolism

Improved peripheral glucose uptake and utilization

Enhanced glycemic control
Hepatic Effect

Reduced hepatic glucose production and output

Improved fasting glucose levels
Pharmacokinetic Profile

Once-daily dosing with sustained antidiabetic activity

Patient-friendly dosing regimen

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia pharmaceutical grade compliance

EP Standards

European Pharmacopoeia specifications and testing protocols

ICH Guidelines

International harmonized pharmaceutical development standards

Global Regulatory

Multi-regional pharmaceutical registration support

DMF Support

Drug Master File preparation and regulatory submission

GMP Compliance

Good Manufacturing Practice certified production

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory assistance to optimize Pioglitazone hydrochloride performance in pharmaceutical applications.

Formulation Development
  • Tablet formulation optimization
  • Bioavailability enhancement
  • Stability improvement strategies
  • Combination therapy development
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Stability testing programs
  • PPARγ receptor binding assays
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Controlled storage packaging
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

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

Green Chemistry

Environmentally conscious synthesis with minimal waste

Water Management

Advanced wastewater treatment and recycling systems

Energy Efficiency

Optimized manufacturing processes with reduced energy consumption

Waste Reduction

Comprehensive waste minimization and disposal protocols

ISO 14001

Environmental management system certified production

Carbon Footprint

Reduced environmental impact through sustainable practices

Manufacturing Excellence & Quality Control

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

GMP Production

Good Manufacturing Practice certified facility with controlled environments

Pharmaceutical-grade production standards
Quality Testing

Comprehensive analytical testing including potency and purity

HPLC, LC-MS, and PPARγ assays
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Controlled atmosphere packaging with moisture protection

Stability maintenance and protection systems

Market Applications & Performance Data

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

Pharmaceutical Manufacturing
Bioavailability: >80% oral absorption Half-life: 16-24 hours elimination Purity: >99.5% pharmaceutical grade
Drug Development
Formulation Support: Antidiabetic products Regulatory Success: Global approvals achieved Innovation: Combination therapies
Clinical Applications
Efficacy: PPARγ agonist activity Safety: Established cardiovascular profile Specialization: Type 2 diabetes treatment

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with pharmaceutical-grade quality and performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production

Development Expertise

Dedicated pharmaceutical team provides formulation development and regulatory support

Quality Assurance

Comprehensive documentation with pharmaceutical-grade certificates and regulatory compliance

Global Standards

International compliance with USP, EP, and ICH guidelines for worldwide acceptance

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services