Niacin USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Niacin USP/EP

High-purity pharmaceutical grade Niacin (Vitamin B3) manufactured under stringent cGMP conditions. This essential vitamin API is crucial for nutritional and cardiovascular applications, particularly in cholesterol management 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 Cardiovascular Health
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C6H5NO2
CAS Number: 59-67-6
EINECS Number: 200-441-0
Purity (HPLC): ≥99.5% (USP/EP Grade)
Physical State: White crystalline powder
Molecular Weight: 123.11 g/mol
Melting Point: 235-237°C
pH (1% solution): 2.7-4.0
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: 25kg, 50kg drums

Applications

Cardiovascular Health
Cholesterol Management
Nutritional Supplements
Energy Metabolism
Pharmaceutical Research
Metabolic Disorders
Neurological Support
Extended Release Formulations
Injectable Preparations
Nutritional Products
Clinical Research
Drug Development

Industry-Specific Grades

DRAVYOM offers specialized Niacin grades tailored for specific pharmaceutical and nutritional applications, ensuring optimal therapeutic efficacy 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
Feed Grade
Purity: ≥99.0% Feed Safety: Verified Stability: Enhanced Application: Animal nutrition
Extended Release Grade
Purity: ≥99.5% Particle Size: Controlled Flow Properties: Optimized Application: SR formulations

Quality Standards

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

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

Advanced Chemical Properties & Performance

Niacin exhibits exceptional vitamin B3 properties essential for pharmaceutical and nutritional applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding cardiovascular and supplement formulations.

Molecular Properties
Molecular Weight: 123.11 g/mol
LogP: 0.36
pKa: 4.85
Bioavailability: Near 100%
Physical Properties
Melting Point: 236-238°C
Solubility (Water): 1 g in 60 mL
Crystalline Form: White crystalline powder
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Vitamin Activity: High potency
Lipid Lowering: Potent
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 3-8

Performance Characteristics

Detailed performance metrics demonstrate Niacin superiority in pharmaceutical applications with exceptional vitamin activity, lipid modulation, and reproducibility across diverse cardiovascular 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

Niacin functions as a key precursor to NAD+ cofactors, enabling essential cellular energy metabolism and lipid regulation through well-characterized biochemical pathways with therapeutic efficacy.

NAD+ Synthesis

Conversion to nicotinamide adenine dinucleotide cofactor

Essential for cellular energy metabolism
Lipid Metabolism

Regulation of cholesterol and triglyceride synthesis

Cardiovascular health benefits
Vasodilation

Prostaglandin-mediated vascular smooth muscle relaxation

Improved peripheral circulation
Pharmacokinetic Profile

Rapid absorption with hepatic metabolism

Predictable 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 Niacin performance in pharmaceutical applications.

Formulation Development
  • Sustained-release 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 Niacin 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 Niacin 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 Niacin 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: 100+ successful formulations Regulatory Success: Global approvals achieved Innovation: Extended-release technologies
Clinical Applications
Efficacy: Proven lipid-lowering effects Safety: Established clinical profile Compliance: Well-tolerated 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