Siponimod Pharmaceutical API
Pharmaceutical Premium
Pharmaceutical API

Siponimod

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

  • USP/EP Compliant Grade
  • High Purity (>99.5%)
  • S1P Receptor Modulator
  • GMP Certified Manufacturing
  • Reliable Supply Chain
  • Complete Documentation
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Technical Specifications

Chemical Formula: C29H35F3N2O4
CAS Number: 1230487-00-9
EINECS Number: Not available
Purity (HPLC): ≥99.5% (USP/EP Grade)
Physical State: White to off-white crystalline powder
Molecular Weight: 516.61 g/mol
Melting Point: 168-172°C
pH (1% solution): 6.0-8.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Practically insoluble in water
Storage Conditions: Store at 15-30°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 100g, 500g, 1kg containers

Applications

Multiple Sclerosis
S1P Receptor Modulation
Oral Tablet Formulations
Neurological Disorders
Immunomodulation
Autoimmune Treatment
Neurology Applications
CNS Drug Development
Pharmaceutical Research
Clinical Trials
API Manufacturing
Specialty Pharmaceuticals

Industry-Specific Grades

DRAVYOM offers specialized Siponimod grades tailored for specific neurological applications, ensuring optimal S1P receptor modulation and regulatory compliance across diverse pharmaceutical formulations.

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: MS research
MS Grade
Purity: ≥99.8% Immunomodulation: Optimized Efficacy: Enhanced Application: Multiple sclerosis

Quality Standards

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

cGMP Manufacturing Standards
USP/EP Grade Specifications
≥99.5% HPLC Purity
Advanced Analytical Testing
S1P Activity Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Controlled Storage & Shipping

Advanced Chemical Properties & Performance

Pharmaceutical Grade Siponimod exhibits exceptional chemical properties essential for immunomodulation applications. Its potent sphingosine-1-phosphate receptor modulator structure and superior stability characteristics ensure reliable performance in demanding multiple sclerosis treatment formulations.

Molecular Properties
Molecular Weight: 516.65 g/mol
Molecular Formula: C29H35F3N2O3
LogP (Octanol/Water): 5.2
pKa: 9.1
Physical Properties
Melting Point: 128-132°C
Appearance: White to off-white crystalline powder
Solubility (Water): Practically insoluble
Bulk Density: 0.45-0.55 g/cm³
Pharmaceutical Properties
Bioavailability: 84%
Protein Binding: ≥99.9%
Half-life: 30 hours
Mechanism: S1P1 and S1P5 receptor modulation
Quality Specifications
Purity (HPLC): ≥99.0%
Water Content: ≤0.5%
Related Substances: ≤1.0%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-25°C
Light Sensitivity: Store in light-resistant containers
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate Siponimod superiority in immunomodulation applications with exceptional S1P receptor selectivity, lymphocyte sequestration efficacy, and therapeutic benefits across diverse multiple sclerosis treatment protocols.

S1P Receptor Selectivity

Selective S1P1 and S1P5 receptor modulation

Targeted immune modulation
CNS Protection

Central nervous system protection

Multiple sclerosis progression control
Lymphocyte Sequestration

Effective lymphocyte trafficking control

Reduced CNS inflammation
Extended Half-life

30-hour elimination half-life

Once-daily dosing convenience
FDA Approval

FDA-approved for secondary progressive MS

Proven neurological benefits
Oral Administration

Convenient oral dosing for patients

Patient compliance advantage

Safety Information

Potent immunomodulatory pharmaceutical active ingredient requiring specialized handling protocols. Handle in controlled environments with appropriate containment systems. Use proper personal protective equipment and follow established safety protocols for S1P receptor modulators.

Immunomodulatory Agent
Controlled Handling Required
Standard PPE Required

Storage & Handling

Store in tightly closed, light-resistant containers in a cool, dry place away from direct sunlight. Maintain controlled room temperature storage and ensure protection from moisture and humidity to preserve pharmaceutical quality and immunomodulatory potency.

Controlled room temperature (15-25°C)
Protect from light
Light-resistant containers
Store in dry conditions

Chemical Mechanisms & Reaction Pathways

Siponimod exhibits specific sphingosine 1-phosphate receptor modulator mechanisms essential for multiple sclerosis treatment. Its molecular structure enables selective S1P1 and S1P5 receptor binding with predictable immunomodulatory therapeutic responses.

S1P Receptor Modulation

Selective S1P1 and S1P5 receptor functional antagonism

Lymphocyte sequestration
Metabolic Pathways

Hepatic metabolism via CYP2C9 and CYP3A4 pathways

Active metabolite formation
CNS Selectivity

Preferential CNS penetration with neurological targeting

Multiple sclerosis treatment
Immunomodulatory Effects

Reduced inflammatory cell infiltration in CNS

Neuroprotection and demyelination prevention

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international drug development and manufacturing standards.

USP Specifications

United States Pharmacopeia pharmaceutical standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical quality

ICH Guidelines

International Conference on Harmonization standards compliance

GMP Certification

Good Manufacturing Practices certified production facility

DMF Support

Drug Master File documentation for regulatory submissions

CEP Available

Certificate of Suitability to European Pharmacopoeia monographs

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, regulatory assistance, and technical services to optimize pharmaceutical performance in your specific drug development applications.

Formulation Development
  • Dosage form optimization support
  • Stability testing guidance
  • Bioavailability enhancement
  • Custom formulation development
Analytical Services
  • Method development and validation
  • Impurity profiling and identification
  • Stability indicating methods
  • Dissolution testing support
Regulatory Support
  • Regulatory submission assistance
  • DMF preparation and maintenance
  • Pharmacovigilance support
  • Global registration strategy
Supply Solutions
  • Pharmaceutical supply chain management
  • Cold chain logistics
  • Custom packaging solutions
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical production emphasizes environmental responsibility through sustainable manufacturing practices, green chemistry principles, and comprehensive environmental impact management for pharmaceutical operations.

Green Chemistry

Sustainable synthetic routes with minimal environmental impact

Water Management

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Packaging

Recyclable pharmaceutical packaging solutions

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent pharmaceutical quality and performance across all production batches.

Production Process

Advanced synthesis and purification in GMP-controlled clean-room environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive testing protocol including purity, potency, and impurity profiling

HPLC, GC-MS, and spectroscopic analysis
Quality Systems

ISO 9001:2015 and GMP quality management systems

Continuous improvement and validation protocols
Packaging Control

Pharmaceutical-grade packaging with controlled atmosphere

Contamination prevention and stability protection

Market Applications & Performance Data

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

Pharmaceutical Development
Formulation Success: 95+ formulations developed Regulatory Approvals: 100+ successful submissions Quality Consistency: 99.9% batch compliance
Research Applications
Clinical Studies: 200+ supported trials Publication Support: 150+ peer-reviewed papers Innovation: Custom API development
Commercial Manufacturing
Scale-up Success: 100% process transfers Supply Reliability: 99.8% on-time delivery Cost Optimization: 25% average cost reduction

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds pharmacopeial specifications with superior purity and pharmaceutical performance

Reliable Supply

Guaranteed pharmaceutical availability with strategic inventory and GMP production scheduling

Development Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Regulatory Assurance

Complete regulatory packages with DMF support and global registration assistance

Global Standards

International compliance with USP, EP, and ICH standards for worldwide market access

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services