Metformin HCl
Pharmaceutical Premium
Pharmaceutical API

Metformin HCl

High-purity pharmaceutical grade Metformin HCl 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: C4H11N5·HCl
CAS Number: 1115-70-4
EINECS Number: 214-230-6
Molecular Weight: 165.62 g/mol
Physical State: White crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 223-226°C
pH (1% solution): 6.0-7.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% (total impurities)
Storage Conditions: Store at room temperature, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 25kg drums, 50kg containers

Applications

Type 2 Diabetes Treatment
Glycemic Control
Biguanide Therapy
Insulin Sensitizer
Diabetes Research
Endocrinology Units
Pharmaceutical Manufacturing
Glucose Metabolism
Metabolic Research
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Metformin HCl grades tailored for specific antidiabetic pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse diabetes treatment 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) Impurities: Individual ≤0.5% Loss on Drying: ≤0.5% Application: EU regulatory submissions
Diabetes Research Grade
Purity: ≥99.5% (HPLC) Water Content: ≤0.2% Residue on Ignition: ≤0.05% Application: Metabolic research
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

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

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
Ultra-Low Impurity Levels
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Metformin HCl exhibits exceptional pharmaceutical properties essential for diabetes management applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and antidiabetic therapies.

Pharmaceutical Properties
Molecular Weight: 165.63 g/mol
Solubility (Water): Freely soluble
Partition Coefficient: LogP = -2.6
Bioavailability: 50-60% oral absorption
Physical Properties
Melting Point: 223-226°C
Appearance: White crystalline powder
Crystalline Form: Stable polymorphic form
Bulk Density: 0.50-0.70 g/mL
Formulation Performance
Dissolution Rate: ≥85% in 30 minutes
Tablet Hardness: 4-10 kp compatible
Compressibility: Excellent direct compression
Flow Properties: Good to excellent
Purity Specifications
Total Impurities: ≤1.0%
Related Substances: ≤0.5% individual
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Stable to light
Temperature Stability: Stable 15-30°C
Humidity Sensitivity: Store below 65% RH

Performance Characteristics

Detailed performance metrics demonstrate Metformin HCl superiority in pharmaceutical applications with exceptional efficacy, bioavailability, and reproducibility across diverse formulation types and therapeutic protocols.

Therapeutic Performance

Bioavailability: 50-60% oral absorption

Excellent antidiabetic efficacy
Dissolution Rate

Release: ≥85% in 30 minutes

Consistent drug release profile
Analytical Performance

Purity: ≥99.0% HPLC

Superior analytical precision
Stability Performance

Shelf life: 5 years under proper storage

Extended pharmaceutical integrity
Batch Reproducibility

Variation: ±1.0% between batches

Exceptional lot-to-lot consistency
Processing Performance

Compressibility: Excellent direct compression

Superior manufacturing efficiency

Safety Information

Pharmaceutical grade material requiring appropriate handling procedures. Use standard pharmaceutical safety protocols including proper ventilation, protective equipment, and trained personnel. Follow all applicable regulatory guidelines for pharmaceutical manufacturing and handling.

Pharmaceutical Material
Trained Personnel Required
cGMP Compliance

Storage & Handling

Store in original pharmaceutical packaging in a controlled environment. Maintain temperature and humidity conditions as specified. Use appropriate material handling equipment and ensure proper documentation for pharmaceutical traceability and regulatory compliance.

Controlled temperature (15-30°C)
Humidity control (≤65% RH)
Protect from contamination
Complete documentation required

Chemical Mechanisms & Reaction Pathways

Metformin HCl exhibits unique antidiabetic activity through multiple metabolic pathways and cellular mechanisms, enabling precise glucose management applications with insulin sensitization and hepatic glucose regulation.

AMPK Activation

Activates AMP-activated protein kinase pathway

Enhances cellular energy metabolism and glucose uptake
Hepatic Gluconeogenesis

Inhibits hepatic glucose production and gluconeogenesis

Reduces fasting glucose levels
Insulin Sensitivity

Improves peripheral insulin sensitivity and glucose utilization

Enhances muscle glucose uptake
Mitochondrial Effects

Modulates mitochondrial respiratory chain complex I

Affects cellular energy metabolism

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia diabetes pharmaceutical grade standards compliance

EP Standards

European Pharmacopoeia specifications for antidiabetic pharmaceutical manufacturing

cGMP Manufacturing

Current Good Manufacturing Practice certified diabetes API production

ICH Guidelines

International Conference on Harmonisation diabetes quality standards

DMF Support

Drug Master File documentation for diabetes regulatory submissions

Quality Documentation

Complete antidiabetic API documentation package with stability data

Technical Support & Value-Added Services

DRAVYOM's diabetes pharmaceutical development team provides comprehensive formulation support, antidiabetic drug development guidance, and regulatory support to optimize Metformin HCl performance in diabetes management applications.

Formulation Development
  • Extended release tablet optimization
  • Immediate release formulation design
  • Bioavailability enhancement strategies
  • Taste masking for oral formulations
Analytical Services
  • Certificate of Analysis verification
  • Diabetes API impurity profiling
  • Dissolution method validation
  • Stability testing programs
Technical Support
  • Diabetes pharmaceutical troubleshooting
  • cGMP compliance for antidiabetic APIs
  • Process optimization support
  • Regulatory documentation assistance
Supply Solutions
  • Consistent diabetes grade scheduling
  • Emergency antidiabetic API supply
  • Bulk packaging solutions
  • Global pharmaceutical distribution

Environmental Impact & Sustainability

Our Metformin HCl production emphasizes environmental responsibility through sustainable diabetes pharmaceutical manufacturing practices, waste minimization, and comprehensive environmental impact management.

Waste Minimization

Optimized synthesis with minimal diabetes pharmaceutical waste generation

Water Treatment

Advanced pharmaceutical wastewater treatment and recycling systems

Green Chemistry

Environmentally conscious antidiabetic API synthesis with emission controls

Safe Disposal

Comprehensive guidance for diabetes pharmaceutical waste management

ISO 14001

Environmental management system certified pharmaceutical production

Carbon Footprint

Reduced carbon footprint through antidiabetic API process optimization

Manufacturing Excellence & Quality Control

DRAVYOM's specialized diabetes pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Metformin HCl quality and performance across all production batches.

Production Process

Advanced synthesis and purification in controlled diabetes API environment

Multi-stage crystallization for pharmaceutical grade diabetes quality
Quality Testing

Comprehensive analytical testing including diabetes API related substances

HPLC verification and antidiabetic-specific analysis
Quality Systems

ISO 9001:2015 quality management with diabetes pharmaceutical accreditation

Specialized antidiabetic API quality systems
Packaging Control

Pharmaceutical-grade containers with diabetes API protection

Moisture control and stability preservation

Market Applications & Performance Data

Comprehensive diabetes pharmaceutical development data demonstrating Metformin HCl effectiveness across diverse therapeutic applications with quantified performance metrics and antidiabetic development validations.

Diabetes Manufacturing
Bioavailability: 50-60% oral absorption Stability: 5+ years shelf life Purity: >99.5% diabetes grade
Clinical Applications
Efficacy: First-line Type 2 diabetes treatment Safety: Well-established diabetes profile Regulatory: Global antidiabetic approvals
Manufacturing Scale
Capacity: Multi-ton annual diabetes production Consistency: <0.1% batch-to-batch variation Compliance: 100% diabetes cGMP adherence

DRAVYOM Competitive Advantages

Diabetes Expertise

Specialized antidiabetic manufacturing with ultra-low impurities and exceptional diabetes pharmaceutical performance

Reliable Supply

Guaranteed availability with diabetes inventory management and antidiabetic-grade production scheduling

Diabetes Expertise

Dedicated diabetes pharmaceutical development team with antidiabetic formulation expertise

Quality Assurance

Comprehensive certificates with complete analytical data and diabetes documentation

Global Standards

International compliance with USP, EP, and ICH specifications for worldwide diabetes pharmaceutical acceptance

Partnership Approach

Collaborative relationships with diabetes pharmaceutical companies and custom antidiabetic API development