Montelukast Sodium API
Pharmaceutical Premium
Pharmaceutical API

Montelukast Sodium

High-purity pharmaceutical grade Montelukast Sodium API manufactured to meet stringent USP/EP specifications for asthma and allergy treatment formulations. Our pharmaceutical grade API delivers exceptional purity and consistency for critical drug manufacturing applications.

  • USP/EP Grade Quality Standards
  • High Purity ≥99.0% (HPLC)
  • Comprehensive Analytical Documentation
  • Regulatory Compliance Support
  • cGMP Manufacturing Standards
  • Pharmaceutical Grade Packaging
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Technical Specifications

Chemical Formula: C35H35ClNNaO3S
CAS Number: 151767-02-1
EINECS Number: Not available
Molecular Weight: 608.18 g/mol
Physical State: White to off-white powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 120-130°C (decomposition)
pH (1% solution): 7.0-9.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% (total impurities)
Storage Conditions: Store below 25°C, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 25kg drums, 100kg containers

Applications

Asthma Treatment
Allergic Rhinitis
Leukotriene Receptor Antagonist
Pediatric Asthma
Respiratory Research
Hospital Pulmonology
Pharmaceutical Manufacturing
Anti-Inflammatory
Allergy Research
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Montelukast Sodium grades tailored for specific respiratory pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse asthma and allergy treatment applications.

USP Grade (United States Pharmacopeia)
Purity: ≥99.0% (HPLC) Loss on Drying: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (HPLC) pH Range: 7.0-9.0 Related Substances: ≤1.0% Application: EU regulatory submissions
Respiratory Research Grade
Purity: ≥99.5% (HPLC) Enhanced bioavailability Low endotoxin levels Application: Asthma research
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Montelukast Sodium API is manufactured under stringent quality control protocols, meeting international pharmaceutical standards including USP, EP, and cGMP specifications. Our pharmaceutical-grade production ensures consistent performance and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
Light-Protected Processing
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Montelukast Sodium exhibits exceptional leukotriene receptor antagonist properties essential for respiratory applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding asthma treatment formulations.

Molecular Properties
Molecular Weight: 608.18 g/mol
LogP: 5.6
pKa: 5.7
Bioavailability: 64%
Physical Properties
Melting Point: 160-165°C
Solubility (Water): 0.49 mg/mL
Crystalline Form: Stable sodium salt
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
CysLT1 IC50: 2.1 nM
Receptor Binding: High affinity
Selectivity: CysLT1 selective
Stability: Light-sensitive
Purity Specifications
Assay: ≥99.0%
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: Controlled temperature
pH Stability: Stable pH 4-7

Performance Characteristics

Detailed performance metrics demonstrate Montelukast Sodium superiority in respiratory applications with exceptional leukotriene antagonism, bioavailability, and reproducibility across diverse asthma treatment formulations.

CysLT1 Antagonism

IC50: 2.1 nM receptor binding

Potent leukotriene blockade
Bioavailability

Oral: 64% bioavailability

Excellent drug absorption
Stability

Solid state: >3 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 15-25°C processing

Controlled temperature requirement
Batch Reproducibility

Variation: ±0.5% between batches

Consistent lot-to-lot performance
Shelf Stability

3 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade respiratory 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.

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

Chemical Mechanisms & Reaction Pathways

Montelukast Sodium exhibits potent leukotriene receptor antagonism and anti-inflammatory activity, enabling precise respiratory applications with enhanced bronchodilation and asthma control properties.

CysLT1 Receptor Antagonism

Selective antagonist of cysteinyl leukotriene receptor 1

Blocks bronchoconstriction and inflammation
Leukotriene Pathway Inhibition

Prevents leukotriene-mediated inflammatory responses

Reduces airway inflammation and mucus production
Anti-Inflammatory Action

Inhibits inflammatory cell recruitment and activation

Prevents eosinophil and neutrophil infiltration
Bronchodilation

Promotes smooth muscle relaxation in airways

Improves airflow and respiratory function

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international standards and respiratory pharmaceutical regulatory requirements.

USP Specifications

United States Pharmacopeia respiratory pharmaceutical grade standards compliance

EP Standards

European Pharmacopoeia specifications for leukotriene antagonist manufacturing

cGMP Manufacturing

Current Good Manufacturing Practice certified respiratory API production

ICH Guidelines

International Conference on Harmonisation respiratory quality standards

DMF Support

Drug Master File documentation for respiratory regulatory submissions

Safety Documentation

Complete respiratory safety and handling documentation package

Technical Support & Value-Added Services

DRAVYOM's respiratory pharmaceutical development team provides comprehensive formulation support, chewable tablet guidance, and regulatory support to optimize Montelukast Sodium performance in your respiratory pharmaceutical applications.

Formulation Development
  • Chewable tablet formulation
  • Oral granule development
  • Taste masking strategies
  • Stability enhancement guidance
Analytical Services
  • Certificate of Analysis verification
  • Respiratory API impurity profiling
  • Stability method validation
  • Dissolution testing programs
Technical Support
  • Respiratory API handling consultation
  • cGMP compliance for respiratory manufacturing
  • Salt form optimization
  • Regulatory documentation support
Supply Solutions
  • Specialized respiratory packaging
  • Humidity-controlled logistics
  • Emergency respiratory supply
  • Global pharmaceutical distribution

Environmental Impact & Sustainability

Our Montelukast Sodium production emphasizes environmental responsibility through sustainable respiratory pharmaceutical manufacturing practices, waste minimization, and comprehensive environmental impact management for leukotriene antagonist API operations.

Waste Minimization

Optimized synthesis with minimal respiratory pharmaceutical waste generation

Water Treatment

Advanced pharmaceutical wastewater treatment and recycling systems

Green Chemistry

Environmentally conscious respiratory API synthesis with emission controls

Safe Disposal

Comprehensive guidance for respiratory pharmaceutical waste management

ISO 14001

Environmental management system certified pharmaceutical production

Carbon Footprint

Reduced carbon footprint through respiratory API process optimization

Manufacturing Excellence & Quality Control

DRAVYOM's specialized respiratory pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Montelukast Sodium quality and potency across all production batches.

Production Process

Advanced synthesis and crystallization in controlled respiratory environment

Multi-stage purification for respiratory pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing including leukotriene activity analysis

HPLC verification and salt content analysis
Quality Systems

ISO 9001:2015 quality management with respiratory pharmaceutical accreditation

Specialized respiratory API quality systems
Packaging Control

Specialized moisture-resistant containers with humidity monitoring

Moisture protection and stability systems

Market Applications & Performance Data

Comprehensive respiratory pharmaceutical development data demonstrating Montelukast Sodium effectiveness across diverse therapeutic applications with quantified performance metrics and asthma treatment validations.

Respiratory Manufacturing
Bioavailability: 64% oral bioavailability Stability: Moisture-sensitive salt form Purity: >99.5% respiratory grade
Clinical Applications
Efficacy: Proven asthma and allergic rhinitis treatment Safety: Established respiratory safety profile Regulatory: Global respiratory approvals
Manufacturing Capabilities
Capacity: Controlled respiratory production batches Consistency: <0.3% batch-to-batch variation Compliance: 100% respiratory cGMP adherence

DRAVYOM Competitive Advantages

Respiratory Expertise

Specialized respiratory manufacturing with ultra-low impurities and exceptional leukotriene antagonist pharmaceutical performance

Reliable Supply

Guaranteed availability with specialized inventory management and respiratory-grade production scheduling

Salt Form Expertise

Dedicated respiratory pharmaceutical development team with sodium salt formulation expertise

Quality Assurance

Comprehensive certificates with complete analytical data and respiratory handling documentation

Global Standards

International compliance with USP, EP, and ICH specifications for worldwide respiratory pharmaceutical acceptance

Partnership Approach

Collaborative relationships with respiratory pharmaceutical companies and custom leukotriene antagonist API development