Nicorandil Pharmaceutical API
Pharmaceutical Premium
Pharmaceutical API

Nicorandil

High-purity pharmaceutical grade Nicorandil API manufactured to meet stringent USP/EP specifications for cardiovascular medication production. Our pharmaceutical-grade Nicorandil delivers exceptional quality and consistency for critical pharmaceutical applications.

  • USP/EP Compliant Grade
  • High Purity (>99.5%)
  • Cardiovascular Medicine API
  • GMP Certified Manufacturing
  • Reliable Supply Chain
  • Complete Documentation
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Technical Specifications

Chemical Formula: C8H9N3O4
CAS Number: 65141-46-0
EINECS Number: 265-572-7
Purity (HPLC): ≥99.5% (USP/EP Grade)
Physical State: White to off-white crystalline powder
Molecular Weight: 211.17 g/mol
Melting Point: 92-95°C
pH (1% solution): 6.0-8.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Soluble in water, methanol
Storage Conditions: Store below 25°C, dry place
Shelf Life: 3 years from manufacture date
Packaging Options: 25kg, 50kg fiber drums

Applications

Cardiovascular Medicine
Angina Pectoris Treatment
Tablet Formulations
Coronary Vasodilation
Pharmaceutical Research
Cardiac Therapy
Blood Pressure Management
Extended Release Tablets
Clinical Studies
Drug Development
Pharmacological Research
Regulatory Studies

Industry-Specific Grades

DRAVYOM offers specialized Nicorandil grades tailored for specific cardiovascular pharmaceutical 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: FDA approved formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.5% Related Substances: ≤0.5% Residual Solvents: EP limits Application: European market compliance
Research Grade
Purity: ≥98.0% Activity: Verified Stability: Enhanced Application: R&D, preclinical studies
Extended Release Grade
Purity: ≥99.5% Particle Size: Controlled Flow Properties: Optimized Application: SR formulations

Quality Standards

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

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

Advanced Chemical Properties & Performance

Nicorandil exhibits exceptional potassium channel opener properties essential for cardiovascular applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding antianginal formulations.

Molecular Properties
Molecular Weight: 211.17 g/mol
LogP: -0.2
pKa: 1.8
Bioavailability: ~75%
Physical Properties
Melting Point: 92-95°C
Solubility (Water): 20 mg/mL
Crystalline Form: White crystalline powder
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
K⁺ Channel Opening: Potent
Vasodilation: Coronary selective
Selectivity: KATP channel selective
Stability: Stable in formulations
Purity Specifications
Assay: ≥99.5%
Related Substances: ≤0.5%
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Room temperature stable
pH Stability: Stable pH 4-7

Performance Characteristics

Detailed performance metrics demonstrate Nicorandil superiority in cardiovascular applications with exceptional potassium channel opening, coronary vasodilation, and reproducibility across diverse antianginal formulations.

Channel Opening

KATP: Potent channel activation

Effective vasodilation
Bioavailability

Oral: ~75% bioavailability

Good systemic exposure
Stability

Solid state: >3 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 15-30°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 cardiovascular API requiring careful 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 light and moisture. Keep containers tightly closed and protect from direct sunlight. Use appropriate containment measures for pharmaceutical API handling.

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

Chemical Mechanisms & Reaction Pathways

Nicorandil demonstrates dual cardiovascular mechanisms through potassium channel activation and nitric oxide donation, providing unique antianginal and cardioprotective effects with proven therapeutic efficacy.

K+ Channel Activation

ATP-sensitive potassium channel opening in vascular smooth muscle

Coronary vasodilation and preconditioning
NO Donation

Nitric oxide release via organic nitrate mechanism

Venous dilation and preload reduction
Cardioprotection

Ischemic preconditioning and myocardial protection

Reduced ischemia-reperfusion injury
Pharmacokinetic Profile

Oral bioavailability with hepatic metabolism

Convenient oral dosing regimen

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 Nicorandil performance in pharmaceutical applications.

Formulation Development
  • Extended-release formulations
  • Bioavailability optimization
  • Stability enhancement strategies
  • Tablet and capsule 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 Nicorandil 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 Nicorandil 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 potency and stability

HPLC, LC-MS, and pharmacopeial methods
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Controlled atmosphere packaging with light protection

Photosensitive drug protection systems

Market Applications & Performance Data

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

Pharmaceutical Manufacturing
Bioavailability: ~75% oral absorption Stability: 3+ years shelf life Purity: >99.5% pharmaceutical grade
Drug Development
Formulation Support: Proven oral formulations Regulatory Success: Global approvals achieved Innovation: Extended-release technologies
Clinical Applications
Efficacy: Proven antianginal activity Safety: Established cardiovascular safety Convenience: Oral dosing regimen

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