Niacinamide USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Niacinamide USP/EP

High-purity pharmaceutical grade Niacinamide (Vitamin B3) manufactured under stringent cGMP conditions. This essential vitamin API is crucial for nutritional and cosmetic applications, particularly in skin health and energy metabolism, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.5% Purity (HPLC)
  • Comprehensive COA Documentation
  • Vitamin B3 for Skin Health
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C6H6N2O
CAS Number: 98-92-0
EINECS Number: 202-713-4
Purity (HPLC): ≥99.5% (USP/EP Grade)
Physical State: White crystalline powder
Molecular Weight: 122.12 g/mol
Melting Point: 128-131°C
pH (5% solution): 5.0-7.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Soluble in water, ethanol
Storage Conditions: Store below 25°C, dry place
Shelf Life: 3 years from manufacture date
Packaging Options: 25kg, 50kg drums

Applications

Nutritional Supplements
Dermatological Products
Cardiovascular Support
Skin Care Formulations
Pharmaceutical Research
Anti-aging Products
Metabolic Health
Oral Formulations
Topical Applications
Cosmetics Industry
Research Applications
Pharmaceutical APIs

Industry-Specific Grades

DRAVYOM offers specialized Niacinamide grades tailored for specific pharmaceutical and cosmetic applications, ensuring optimal bioavailability and regulatory compliance across diverse formulation requirements.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.5% Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.5% Related Substances: ≤0.5% Residual Solvents: EP limits Application: European market compliance
Cosmetic Grade
Purity: ≥99.0% Particle Size: Optimized Microbial Limits: Cosmetic standards Application: Skin care products
Feed Grade
Purity: ≥99.0% Feed Safety: Verified Stability: Enhanced Application: Animal nutrition

Quality Standards

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

cGMP Manufacturing Standards
USP/EP Grade Specifications
≥99.5% HPLC Purity
Advanced Analytical Testing
Skin Health Benefits Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Controlled Storage & Shipping

Advanced Chemical Properties & Performance

Niacinamide exhibits exceptional vitamin B3 properties essential for pharmaceutical and cosmetic applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding skin care and supplement formulations.

Molecular Properties
Molecular Weight: 122.12 g/mol
LogP: -0.37
pKa: 3.35
Bioavailability: Near 100%
Physical Properties
Melting Point: 128-131°C
Solubility (Water): 1 g in 1 mL
Crystalline Form: White crystalline powder
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Vitamin Activity: High potency
Skin Penetration: Excellent
Selectivity: Vitamin B3 specific
Stability: Stable in formulations
Purity Specifications
Assay: ≥99.5%
Related Substances: ≤0.5%
Heavy Metals: ≤10 ppm
Microbial Limits: USP compliant
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Not light sensitive
Temperature Stability: Room temperature stable
pH Stability: Stable pH 4-9

Performance Characteristics

Detailed performance metrics demonstrate Niacinamide superiority in pharmaceutical applications with exceptional vitamin activity, skin penetration, and reproducibility across diverse formulations.

Vitamin Activity

Potency: High B3 vitamin activity

Effective supplementation
Bioavailability

Oral: Near 100% absorption

Excellent drug availability
Stability

Solid state: >3 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 15-40°C processing

Stable during formulation
Batch Reproducibility

Variation: ±0.3% between batches

Consistent lot-to-lot performance
Shelf Stability

3 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

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

Pharmaceutical API
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 API handling.

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

Chemical Mechanisms & Reaction Pathways

Niacinamide functions as a key precursor to NAD+ and NADP+ cofactors, enabling essential cellular energy metabolism, DNA repair, and skin health benefits through well-characterized biochemical pathways.

NAD+ Synthesis

Conversion to nicotinamide adenine dinucleotide cofactor

Essential for cellular energy metabolism
DNA Repair

PARP-mediated DNA damage repair mechanisms

Cellular protection and longevity
Anti-inflammatory

Inhibition of inflammatory mediator release

Skin health and dermatological benefits
Pharmacokinetic Profile

Rapid absorption with minimal side effects

Well-tolerated therapeutic dosing

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 Niacinamide performance in pharmaceutical applications.

Formulation Development
  • Topical and oral formulations
  • Bioavailability optimization
  • Stability enhancement strategies
  • Dosage form development
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Stability testing programs
  • Dissolution testing support
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Flexible packaging options
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

Our Niacinamide 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 Niacinamide 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 purity and potency

HPLC, UV-VIS, and pharmacopeial methods
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Controlled atmosphere packaging with stability maintenance

Moisture and light protection systems

Market Applications & Performance Data

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

Pharmaceutical Manufacturing
Bioavailability: >95% absorption Stability: 3+ years shelf life Purity: >99.5% pharmaceutical grade
Drug Development
Formulation Support: 150+ successful formulations Regulatory Success: Global approvals achieved Innovation: Dermatological applications
Clinical Applications
Efficacy: Proven skin health benefits Safety: Excellent tolerance profile Compliance: Well-accepted formulations

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