Mirtazapine Pharmaceutical API
API Antidepressant
Pharmaceutical APIs

Mirtazapine

Professional-grade active pharmaceutical ingredient for antidepressant medication manufacturing. Delivers superior purity and stability with excellent bioavailability for pharmaceutical formulation applications requiring the highest quality standards.

  • High Purity API
  • Pharmaceutical Grade
  • Antidepressant Activity
  • Stability Tested
  • GMP Compliant
  • Professional Grade Quality
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Technical Specifications

Chemical Formula: C17H19N3
CAS Number: 85650-52-8
EINECS Number: 288-474-7
Molecular Weight: 265.35 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 116-120°C
pH (1% solution): Not applicable (poorly soluble)
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

Major Depressive Disorder
Antidepressant Therapy
Sleep Disorders
Anxiety Treatment
Psychiatric Research
Hospital Psychiatry
Pharmaceutical Manufacturing
Noradrenergic Activity
CNS Research
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Mirtazapine grades tailored for specific psychiatric pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse antidepressant therapy 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) Melting Point: 116-120°C Related Substances: ≤1.0% Application: EU regulatory submissions
Psychiatric Research Grade
Purity: ≥99.5% (HPLC) Enhanced bioavailability Low endotoxin levels Application: CNS research
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Mirtazapine 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

Pharmaceutical Grade Mirtazapine exhibits exceptional chemical properties essential for psychiatric applications. Its optimal molecular structure and superior stability characteristics ensure reliable performance in demanding antidepressant formulations.

Molecular Properties
Molecular Weight: 265.35 g/mol
Molecular Formula: C17H19N3
LogP (Octanol/Water): 2.9
Solubility (Water): Slightly soluble
Physical Properties
Melting Point: 116-120°C
Appearance: White to off-white crystalline powder
Crystal Form: Anhydrous Form I
Bulk Density: 0.35-0.45 g/cm³
Pharmaceutical Properties
Bioavailability: ~50%
Protein Binding: 85%
Half-life: 20-40 hours
Mechanism: Noradrenergic and specific serotonergic
Quality Specifications
Purity (HPLC): ≥99.0%
Loss on Drying: ≤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 Mirtazapine superiority in psychiatric applications with exceptional antidepressant activity, receptor selectivity, and therapeutic efficacy across diverse mental health treatment protocols.

Antidepressant Activity

Dual mechanism: noradrenergic and serotonergic

Enhanced mood improvement
Receptor Selectivity

High affinity for α2, 5-HT2A, 5-HT2C, 5-HT3

Targeted therapeutic action
Tablet Performance

Excellent compression characteristics

Superior tablet integrity
Extended Half-life

20-40 hour elimination half-life

Once-daily dosing convenience
Clinical Efficacy

Proven efficacy in major depression

FDA-approved therapeutic performance
Sleep Enhancement

Improved sleep quality and appetite

Additional therapeutic benefits

Safety Information

Potent pharmaceutical active ingredient requiring careful handling protocols. Handle in controlled environments with appropriate ventilation systems. Use proper personal protective equipment and follow established safety protocols for psychoactive compounds.

CNS Active Compound
Controlled Handling Required
Specialized 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 potency.

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

Chemical Mechanisms & Reaction Pathways

Mirtazapine exhibits unique antidepressant activity through noradrenergic and specific serotonergic pathways, enabling precise psychiatric applications with enhanced mood stabilization and sleep improvement properties.

α2-Adrenergic Antagonism

Blocks presynaptic α2-adrenergic receptors

Increases norepinephrine and serotonin release
5-HT2/5-HT3 Antagonism

Selective serotonin receptor antagonism

Enhances therapeutic serotonin effects
H1 Receptor Antagonism

Antihistaminergic activity promotes sedation

Improves sleep quality and duration
NaSSA Mechanism

Noradrenergic and Specific Serotonergic Antidepressant action

Dual neurotransmitter enhancement

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia psychiatric pharmaceutical grade standards compliance

EP Standards

European Pharmacopoeia specifications for antidepressant pharmaceutical manufacturing

cGMP Manufacturing

Current Good Manufacturing Practice certified psychiatric API production

ICH Guidelines

International Conference on Harmonisation psychiatric quality standards

DMF Support

Drug Master File documentation for psychiatric regulatory submissions

Safety Documentation

Complete psychiatric safety and handling documentation package

Technical Support & Value-Added Services

DRAVYOM's psychiatric pharmaceutical development team provides comprehensive formulation support, controlled release guidance, and regulatory support to optimize Mirtazapine performance in your psychiatric pharmaceutical applications.

Formulation Development
  • Tablet formulation optimization
  • Oral disintegrating tablet design
  • Controlled release formulation
  • Stability enhancement strategies
Analytical Services
  • Certificate of Analysis verification
  • Psychiatric API impurity profiling
  • Stability method validation
  • Bioavailability studies
Technical Support
  • Psychiatric API handling consultation
  • cGMP compliance for CNS manufacturing
  • Dissolution testing optimization
  • Regulatory documentation support
Supply Solutions
  • Specialized psychiatric packaging
  • Temperature-controlled logistics
  • Emergency psychiatric supply
  • Global pharmaceutical distribution

Environmental Impact & Sustainability

Our Mirtazapine production emphasizes environmental responsibility through sustainable psychiatric pharmaceutical manufacturing practices, waste minimization, and comprehensive environmental impact management for CNS API operations.

Waste Minimization

Optimized synthesis with minimal psychiatric pharmaceutical waste generation

Water Treatment

Advanced pharmaceutical wastewater treatment and recycling systems

Green Chemistry

Environmentally conscious psychiatric API synthesis with emission controls

Safe Disposal

Comprehensive guidance for psychiatric pharmaceutical waste management

ISO 14001

Environmental management system certified pharmaceutical production

Carbon Footprint

Reduced carbon footprint through psychiatric API process optimization

Manufacturing Excellence & Quality Control

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

Production Process

Advanced synthesis and purification in controlled psychiatric environment

Multi-stage crystallization for psychiatric pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing including antidepressant activity analysis

HPLC verification and bioactivity analysis
Quality Systems

ISO 9001:2015 quality management with psychiatric pharmaceutical accreditation

Specialized psychiatric API quality systems
Packaging Control

Specialized moisture-resistant containers with controlled atmosphere

Moisture and oxygen protection systems

Market Applications & Performance Data

Comprehensive psychiatric pharmaceutical development data demonstrating Mirtazapine effectiveness across diverse therapeutic applications with quantified performance metrics and antidepressant development validations.

Psychiatric Manufacturing
Bioavailability: 50% oral bioavailability Stability: Moisture-sensitive API Purity: >99.5% psychiatric grade
Clinical Applications
Efficacy: Proven major depressive disorder treatment Safety: Established psychiatric safety profile Regulatory: Psychiatric approvals worldwide
Manufacturing Capabilities
Capacity: Controlled psychiatric production batches Consistency: <0.3% batch-to-batch variation Compliance: 100% psychiatric cGMP adherence

DRAVYOM Competitive Advantages

Psychiatric Expertise

Specialized psychiatric manufacturing with ultra-low impurities and exceptional antidepressant pharmaceutical performance

Reliable Supply

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

CNS Expertise

Dedicated psychiatric pharmaceutical development team with CNS formulation expertise

Quality Assurance

Comprehensive certificates with complete analytical data and psychiatric handling documentation

Global Standards

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

Partnership Approach

Collaborative relationships with psychiatric pharmaceutical companies and custom CNS API development