Povidone (PVP) USP/EP
Pharmaceutical USP/EP
Pharmaceutical Excipient

Povidone (PVP) USP/EP

High-purity pharmaceutical grade Povidone manufactured under stringent cGMP conditions. This versatile excipient is essential for pharmaceutical manufacturing, serving as binder, coating agent, and solubilizer in tablet formulations, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical Excipient
  • cGMP Manufacturing Standards
  • Various K-Values Available
  • Comprehensive COA Documentation
  • Multi-functional Pharmaceutical Excipient
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: (C6H9NO)n
CAS Number: 9003-39-8
EINECS Number: 201-800-4
K-Value: Multiple grades (K17, K25, K30, K90)
Physical State: White to cream-colored powder
Molecular Weight: Variable (depends on K-value)
Viscosity (5% solution): Varies by K-value
pH (5% solution): 3.0-7.0
Loss on Drying: ≤5.0%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Freely soluble in water and ethanol
Storage Conditions: Store below 25°C, dry place
Shelf Life: 5 years from manufacture date
Packaging Options: 1kg, 5kg, 25kg bags

Applications

Tablet Binding Agent
Film Coating Agent
Solubilizing Agent
Tablet Disintegrant
Capsule Formulations
Ophthalmic Solutions
Injectable Preparations
Stabilizing Agent
Sustained Release
Suspension Stabilizer
Controlled Release Matrix
Pharmaceutical Research

Industry-Specific Grades

DRAVYOM offers specialized Povidone grades with various K-values tailored for specific pharmaceutical applications, ensuring optimal binding efficacy and regulatory compliance across diverse formulation requirements.

USP Grade (United States Pharmacopoeia)
K-Values: K17, K25, K30, K90 Water Content: ≤5.0% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
pH Range: 3.0-7.0 Residue on Ignition: ≤0.1% Multiple K-Values: Available Application: European market compliance
Low Molecular Weight Grade (K17)
K-Value: 16.0-18.0 Viscosity: Low Solubility: Enhanced Application: Injection solutions
High Binding Grade (K90)
K-Value: 85-95 Binding Strength: Superior Film Formation: Excellent Application: Tablet binding

Quality Standards

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

cGMP Manufacturing Standards
USP/EP Grade Specifications
Multiple K-Values Available
Advanced Analytical Testing
Binding Efficacy Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Controlled Storage & Shipping

Advanced Chemical Properties & Performance

Povidone exhibits exceptional polymer binding properties essential for pharmaceutical applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding tablet and solution formulations.

Molecular Properties
Molecular Weight: Variable (K-value dependent)
LogP: Hydrophilic
pKa: Not applicable
Bioavailability: Non-absorbed excipient
Physical Properties
Glass Transition: 150-180°C
Solubility (Water): Freely soluble
Crystalline Form: Amorphous polymer
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
K-Value Range: 17-90
Binding Strength: K-value dependent
Selectivity: Universal binder
Stability: Stable in solid state
Purity Specifications
Assay: ≥98.0%
Water Content: ≤5.0%
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Not light sensitive
Temperature Stability: Stable at room temperature
pH Stability: Stable pH 1-14

Performance Characteristics

Detailed performance metrics demonstrate Povidone superiority in pharmaceutical applications with exceptional binding properties, solubility enhancement, and reproducibility across diverse tablet and solution formulations.

Binding Properties

K-value dependent strength

Superior tablet binding
Solubility

Complete water solubility

Enhanced dissolution
Stability

Solid state: >5 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 15-80°C processing

Stable during formulation
Batch Reproducibility

Variation: ±0.5% between batches

Consistent lot-to-lot performance
Shelf Stability

5 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade polymer excipient requiring standard handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for pharmaceutical excipients and ensure proper waste disposal procedures.

Pharmaceutical Excipient
Avoid Skin Contact
Avoid Inhalation

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from moisture. Keep containers tightly closed and protect from humidity. Use appropriate containment measures for pharmaceutical excipient handling.

Room temperature storage (15-25°C)
Protect from moisture
Original sealed containers
Pharmaceutical containment required

Chemical Mechanisms & Reaction Pathways

Povidone functions as a versatile pharmaceutical polymer with excellent solubility and biocompatibility, providing formulations with binding, disintegration, and dissolution enhancement through hydrogen bonding and hydrophilic matrix formation.

Polymer Binding

Strong hydrogen bonding with pharmaceutical actives

Enhances tablet integrity and cohesion
Hydrophilic Properties

Excellent water solubility and wetting characteristics

Improves dissolution profiles
Biocompatibility

Non-toxic, physiologically inert polymer

Safe for pharmaceutical applications
Molecular Weight Versatility

Available in multiple K-value grades

Tailored performance characteristics

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 Povidone performance in pharmaceutical applications.

Formulation Development
  • Tablet binding optimization
  • Dissolution enhancement strategies
  • Sustained release formulations
  • Coating applications
Analytical Services
  • Method validation and transfer
  • K-value determination
  • Viscosity testing programs
  • Molecular weight characterization
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Moisture-controlled packaging
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

Our Povidone 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 Povidone 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 K-value and viscosity

GPC, viscometry, and polymer testing
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Moisture-controlled packaging with contamination prevention

Polymer stability and quality assurance

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Povidone effectiveness across diverse therapeutic applications with quantified performance metrics and regulatory validation.

Pharmaceutical Manufacturing
K-Value Range: K12-K90 available Molecular Weight: 2,500-1,000,000 Da Purity: >99% pharmaceutical grade
Drug Development
Formulation Support: Tablets, capsules, solutions Regulatory Success: Global approvals achieved Innovation: Versatile pharmaceutical polymer
Clinical Applications
Safety: GRAS status pharmaceutical excipient Efficacy: Proven formulation enhancement Versatility: Multiple dosage forms

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