Hydroxypropyl Methylcellulose (HPMC) USP/EP
Pharmaceutical USP/EP
Pharmaceutical Excipient

Hydroxypropyl Methylcellulose (HPMC) USP/EP

High-purity pharmaceutical grade HPMC manufactured under stringent cGMP conditions. This versatile cellulose derivative excipient is essential for controlled release formulations, matrix tablets, and film coating applications, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical Excipient
  • cGMP Manufacturing Standards
  • Multiple Viscosity Grades Available
  • Comprehensive COA Documentation
  • Controlled Release Matrix Former
  • Regulatory Compliance Ready
Request Quote Technical Support

Technical Specifications

Chemical Name: Hydroxypropyl Methylcellulose
CAS Number: 9004-65-3
Molecular Formula: [C6H7O2(OH)3-m-n(OCH3)m(OCH2CHOHCH3)n]x
Viscosity (2% solution): Multiple grades: 3-150,000 cP
Physical State: White to off-white fibrous powder
Moisture Content: ≤5.0%
pH (1% solution): 5.5-8.0
Heavy Metals (as Pb): ≤10 ppm
Residue on Ignition: ≤1.5%
Storage Conditions: Store in cool, dry place in tightly closed container
Packaging Options: 1kg, 5kg, 25kg pharmaceutical containers

Applications

Controlled Release Matrix Tablets
Film Coating Applications
Thickening Agent
Stabilizer & Binder
Capsule Shell Formation
Enteric Coating Applications
Ophthalmic Formulations
Topical Gel Formation
Suspension Stabilizer
Research & Development
Large Scale Manufacturing
Regulatory Compliance

Industry-Specific Grades

DRAVYOM offers specialized HPMC grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse controlled release and excipient applications.

USP Grade (Pharmaceutical)
Viscosity: Various grades available Moisture: ≤5.0% Heavy Metals: ≤10 ppm Application: Tablet matrix, coating
EP Grade (European Pharmacopoeia)
pH: 5.5-8.0 (1% solution) Residue on Ignition: ≤1.5% Microbial Limits: Compliant Application: European market compliance
Coating Grade
Viscosity: Low-Medium grades Film Forming: Excellent Clarity: High transparency Application: Film coating, enteric coating
Sustained Release Grade
Viscosity: High grades (>4000 cP) Gel Strength: Optimized Drug Release: Controlled profile Application: Matrix tablets, SR formulations

Quality Standards

DRAVYOM's pharmaceutical grade HPMC is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and ICH guidelines. Our pharmaceutical-grade production ensures consistent quality and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
Multiple Viscosity Grades
Advanced Analytical Testing
Ultra-Low Impurities
Batch-to-Batch Consistency
Traceable Certificate of Analysis
Controlled Storage & Handling

Advanced Chemical Properties & Performance

Pharmaceutical grade HPMC exhibits precise chemical properties essential for pharmaceutical formulations. Its ultra-pure composition and exact molecular structure ensure reliable therapeutic performance in demanding pharmaceutical applications.

Pharmaceutical Properties
Molecular Weight: 10,000-1,500,000 Da
Viscosity Range: 3-100,000 cP
Methoxy Content: 16.5-20.0%
Hydroxypropyl Content: 4.0-12.0%
Physical Properties
Appearance: White to off-white powder
Particle Size: 80-120 mesh
Bulk Density: 0.25-0.70 g/mL
pH (1% solution): 5.0-8.5
Pharmaceutical Performance
Gel Temperature: 50-55°C
Film Formation: Excellent coating properties
Swelling Capacity: High water uptake
Matrix Properties: Controlled release kinetics
Purity Specifications
Loss on Drying: ≤5.0%
Residue on Ignition: ≤1.5%
Heavy Metals: ≤10 ppm
Microbial Limits: USP/EP compliant
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-30°C
Humidity Sensitivity: Store below 60% RH
Light Sensitivity: Protect from direct light

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade HPMC superiority in pharmaceutical applications with exceptional stability, compatibility, and reproducibility across diverse pharmaceutical formulations.

Formulation Performance

Compatibility: Excellent with all drug classes

Versatile pharmaceutical excipient
Therapeutic Efficacy

Biocompatibility: 100% pharmaceutical grade

Safe for all dosage forms
Dissolution Profile

Release: Customizable controlled release

Optimal pharmaceutical performance
Thermal Stability

Stability: No degradation at 40°C

Excellent long-term stability
Batch Consistency

Variation: ±2% viscosity between batches

Exceptional pharmaceutical uniformity
Shelf Stability

3 years under controlled storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade excipient requiring proper handling procedures. Use appropriate personal protective equipment including gloves, safety goggles, and protective clothing. Ensure adequate ventilation and follow established pharmaceutical handling protocols.

Handle with Care
Eye Protection Required
Avoid Inhalation

Storage & Handling

Store in original pharmaceutical containers in a cool, dry, well-ventilated area away from incompatible materials. Keep containers tightly closed and protect from light and moisture. Follow cGMP storage requirements for pharmaceutical materials.

Controlled temperature (15-30°C)
Control humidity (<60% RH)
Original pharmaceutical packaging
Protect from direct light

Chemical Mechanisms & Reaction Pathways

Hydroxypropyl Methylcellulose exhibits multifunctional pharmaceutical activity through specific polymer chain interactions and hydrogel formation, enabling precise controlled-release applications with predictable dissolution pathways and quantitative matrix interactions.

Polymer Hydration

Water uptake and gel layer formation for controlled drug release

Therapeutic mechanism for extended release
Matrix Formation

Three-dimensional polymer network controlling diffusion rates

Essential for sustained drug delivery
Viscosity Control

Molecular weight-dependent rheological properties

Enables selective pharmaceutical applications
Film Formation

Enteric coating properties for targeted drug delivery

Controlled pharmaceutical environment for dosage forms

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete documentation packages supporting international standards and therapeutic method validations.

USP Grade Specifications

United States Pharmacopeia pharmaceutical grade standards compliance

EP Monograph Standard

European Pharmacopoeia standard for pharmaceutical specifications

IP Grade Available

Indian Pharmacopoeia specifications for pharmaceutical analysis

ICH Guidelines

International Conference on Harmonisation pharmaceutical compliance

Method Validation

Supported pharmaceutical method validation documentation

SDS Documentation

Multi-language Safety Data Sheets (16 sections, GHS compliant)

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, stability testing, and regulatory services to optimize Hydroxypropyl Methylcellulose performance in your specific pharmaceutical applications.

Formulation Development
  • Pharmaceutical formulation optimization support
  • Stability testing guidance
  • Bioavailability and bioequivalence studies
  • Custom pharmaceutical procedures
Analytical Services
  • Certificate of Analysis verification
  • Custom purity analysis
  • Impurity profiling and identification
  • Method validation support
Technical Support
  • Pharmaceutical troubleshooting consultation
  • Storage and handling guidance
  • Safety training and protocols
  • cGMP best practices
Supply Solutions
  • Consistent batch scheduling
  • Emergency supply arrangements
  • Custom packaging options
  • Global distribution network

Environmental Impact & Sustainability

Our Hydroxypropyl Methylcellulose production emphasizes environmental responsibility through sustainable manufacturing practices, waste minimization, and comprehensive environmental impact management for pharmaceutical operations.

Waste Minimization

Optimized production with minimal waste generation

Water Treatment

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive guidance for pharmaceutical waste management

ISO 14001

Environmental management system certified production

Container Recycling

Pharmaceutical container return and recycling programs

Manufacturing Excellence & Quality Control

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

Production Process

Advanced synthesis and purification in controlled cGMP environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing protocol including purity, impurities, and stability

HPLC verification and spectroscopic analysis
Quality Systems

ISO 9001:2015 quality management with cGMP compliance

Continuous improvement and method validation
Packaging Control

Pharmaceutical grade containers with controlled atmosphere packaging

Light protection and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Hydroxypropyl Methylcellulose effectiveness across diverse formulation applications with quantified performance metrics and clinical validation.

Pharmaceutical Manufacturing
Purity: >99.0% pharmaceutical grade Functionality: Controlled-release matrix Stability: 5 years shelf life
Research Institutions
Publications: 1500+ cited studies Applications: 40+ dosage forms Innovation: Custom viscosity grades
Contract Manufacturing
Reliability: 99.9% batch consistency Compliance: 100% regulatory approval Efficiency: 35% cost reduction

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmacopeia specifications with ultra-low impurities and exceptional pharmaceutical performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production scheduling

Pharmaceutical Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Quality Assurance

Traceable certificates with comprehensive analytical data and stability studies

Global Standards

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

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services