Tizanidine Pharmaceutical API
Pharmaceutical Premium
Pharmaceutical API

Tizanidine

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

  • USP/EP Compliant Grade
  • High Purity (>99.5%)
  • Centrally Acting Muscle Relaxant
  • GMP Certified Manufacturing
  • Reliable Supply Chain
  • Complete Documentation
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Technical Specifications

Chemical Formula: C9H8ClN5S
CAS Number: 51322-75-9
Molecular Weight: 253.71 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.5% (USP/EP Grade)
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤0.5% (total impurities)
Particle Size: D90 ≤ 100 μm
pH (1% solution): 4.5-6.5
Solubility: Sparingly soluble in water
Storage Conditions: Store at room temperature, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 25g, 50g, 100g pharmaceutical containers

Applications

Muscle Relaxant Therapy
Oral Tablet Formulations
Capsule Formulations
Neurological Applications
Spasticity Management
Hospital Formulations
Prescription Medicines
Centrally Acting Agent
Muscle Tone Disorders
Immediate Release Tablets
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Tizanidine grades tailored for specific muscle relaxant pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse neurological therapeutic applications.

USP Grade (United States Pharmacopeia)
Purity: ≥99.5% (HPLC) Related Substances: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.5% (HPLC) Loss on Drying: ≤0.5% pH: 4.5-6.5 (1% solution) Application: EU regulatory submissions
Muscle Relaxant Grade
Purity: ≥99.8% (HPLC) Neuropharmacological Activity: Verified Dissolution Profile: Optimized Application: Muscle relaxant medications
Immediate Release Grade
Purity: ≥99.9% (HPLC) Particle Size: Controlled Dissolution Rate: Verified Application: Immediate release tablets

Quality Standards

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

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
≥99.5% HPLC Purity
Advanced Neurological Testing
Muscle Relaxant Activity Verified
Batch-to-Batch Consistency
Comprehensive COA
Pharmaceutical Grade Packaging

Advanced Chemical Properties & Performance

Pharmaceutical Grade Tizanidine exhibits exceptional chemical properties essential for muscle relaxant applications. Its central alpha-2 adrenergic agonist composition and precise specification ensure reliable performance in demanding pharmaceutical formulations and neuromuscular systems.

Chemical Properties
Molecular Formula: C₉H₈ClN₅S
Molecular Weight: 253.71 g/mol
Melting Point: 177-181°C
LogP (Octanol/Water): 1.2
Physical Properties
Appearance: White to off-white crystalline powder
Solubility: Slightly soluble in water
pH (saturated solution): 7.3-8.0
Bulk Density: 0.4-0.6 g/cm³
Pharmaceutical Performance
Bioavailability: 40% (oral)
Half-life: 2.5 hours
Protein Binding: 30%
Mechanism: α₂-adrenergic receptor agonist
Purity Specifications
Assay (HPLC): ≥ 99.5%
Related Substances: ≤ 0.3%
Heavy Metals: ≤ 20 ppm
Residual Solvents: Within ICH limits
Stability Properties
Shelf Life: 3 years (unopened)
Photostability: Stable under normal light
Temperature Stability: Stable 15-25°C
Humidity Stability: Store ≤60% RH

Performance Characteristics

Detailed performance metrics demonstrate Pharmaceutical Grade Tizanidine superiority in muscle relaxant applications with exceptional functionality, stability, and reproducibility across diverse pharmaceutical procedures and neuromuscular protocols.

Muscle Relaxant Efficacy

Potency: Central α₂-adrenergic agonist

Superior spasticity reduction
Onset of Action

Time: 1-2 hours peak effect

Rapid muscle relaxation
Bioavailability

Absorption: 40% oral bioavailability

Predictable therapeutic levels
Formulation Stability

Range: Stable in standard formulations

Consistent performance across dosage forms
Batch Uniformity

Variation: ±0.3% between production batches

Exceptional pharmaceutical grade consistency
Long-term Stability

3 years shelf life with maintained potency

Extended pharmaceutical grade integrity

Safety Information

Prescription pharmaceutical with established safety profile in muscle spasticity treatment. Central nervous system depressant requiring dose monitoring. Handle with standard laboratory precautions including appropriate protective equipment. Avoid inhalation of powder and ensure proper ventilation during processing.

Prescription Only
CNS Depressant
Medical Supervision

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 degradation. Use appropriate pharmaceutical handling procedures and ensure proper environmental controls for stability management.

Cool storage (15-25°C)
Low humidity (≤60% RH)
Normal light exposure acceptable
Original sealed containers

Chemical Mechanisms & Reaction Pathways

Pharmaceutical Grade Tizanidine exhibits selective alpha-2 adrenergic agonist properties through imidazoline structure enabling effective muscle relaxation with central nervous system specificity and minimal peripheral effects.

Alpha-2 Agonism

Selective activation of alpha-2 adrenergic receptors in spinal cord

Central muscle relaxation without direct muscle effects
Spinal Inhibition

Inhibition of excitatory interneurons in spinal pathways

Reduces pathological muscle tone and spasticity
Presynaptic Action

Presynaptic inhibition of neurotransmitter release

Modulates excitatory amino acid transmission
Selective Activity

Minimal cardiovascular effects compared to clonidine

Improved therapeutic window and safety profile

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete API documentation supporting international standards and muscle relaxant drug manufacturing validations.

USP Specifications

United States Pharmacopeia API standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical manufacturing

FDA Approved

FDA approved muscle relaxant API with comprehensive safety data

International Approval

Global regulatory compliance for neurological applications

DMF Documentation

Drug Master File with comprehensive manufacturing and safety data

cGMP Certified

Current Good Manufacturing Practice with CNS API standards

Technical Support & Value-Added Services

DRAVYOM's CNS API team provides comprehensive development support, formulation optimization assistance, and regulatory services for muscle relaxant drug manufacturing with specialized neurological expertise.

API Development
  • CNS formulation support
  • Bioavailability enhancement studies
  • Stability optimization protocols
  • Extended-release development
Analytical Services
  • Certificate of Analysis with CNS-specific testing
  • Polymorphic form characterization
  • Impurity profiling and identification
  • Dissolution study support
Regulatory Support
  • Neurological drug documentation
  • Regulatory filing assistance
  • Clinical trial support
  • Post-market surveillance
Supply Solutions
  • Consistent API supply chains
  • Temperature-controlled logistics
  • Emergency supply protocols
  • Global distribution network

Environmental Impact & Sustainability

Our Pharmaceutical Grade Tizanidine production emphasizes environmental responsibility through green chemistry principles, sustainable synthetic pathways, and comprehensive environmental impact management for API manufacturing.

Green Synthesis

Optimized synthetic routes with minimal environmental impact

Solvent Recovery

Advanced solvent recycling and waste minimization

Clean Production

Energy-efficient synthesis with emission controls

Water Treatment

Advanced wastewater treatment and recycling systems

ISO 14001

Environmental management system certified production

Carbon Reduction

Continuous carbon footprint reduction initiatives

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art CNS API manufacturing facility employs advanced synthetic technology and continuous monitoring systems to ensure consistent Pharmaceutical Grade Tizanidine quality and therapeutic efficacy.

Production Process

Advanced multi-step synthesis with pharmaceutical-grade intermediates

Controlled synthesis for optimal purity and yield
Quality Testing

24-point pharmaceutical testing protocol including polymorphic analysis

HPLC verification and CNS-specific testing
Quality Systems

cGMP compliance with CNS API manufacturing standards

Continuous improvement and process validation
API Packaging

Specialized packaging with moisture and light protection

Stability maintenance and contamination prevention

Market Applications & Performance Data

Comprehensive clinical and pharmaceutical data demonstrating Pharmaceutical Grade Tizanidine effectiveness across diverse muscle relaxant applications with quantified therapeutic metrics and safety profiles.

Spasticity Treatment
Efficacy: 60-80% improvement in muscle tone Onset: 1-2 hours therapeutic effect Duration: 6-8 hours muscle relaxation
Safety Profile
Sedation: Dose-dependent central effects Cardiovascular: Minimal hypotensive effects Hepatic: Requires liver function monitoring
Clinical Applications
Multiple Sclerosis: Effective spasticity management Spinal Cord Injury: Improved functional outcomes Acute Musculoskeletal: Short-term pain relief

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmacopeial specifications with optimal polymorphic control and impurity profile

Reliable Supply

Guaranteed availability with strategic inventory management and CNS API expertise

API Expertise

Specialized CNS API manufacturing with comprehensive development support

Quality Assurance

Enhanced testing protocols with complete documentation and regulatory compliance

Global Standards

International compliance with USP, EP, and CNS drug regulations worldwide

Partnership Approach

Collaborative relationships with neurological pharmaceutical companies and development support