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Mirtazapine Anhydrous – Material Safety Data Sheet (MSDS)

Identification

Product Name: Mirtazapine Anhydrous
Chemical Name: 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine
CAS Number: 85650-52-8
Molecular Formula: C17H19N3
Molecular Weight: 265.36 g/mol
Synonyms: Remeron (when formulated for medical use)
Manufacturer: [Contact supplier for manufacturer-specific details]
Recommended Uses: Pharmaceutical intermediate, research chemical
Emergency Phone Number: [Contact local poison control or emergency services]

Hazard Identification

GHS Classification: Not fully classified, use caution as a pharmaceutical compound
Acute Toxicity: May cause irritation to respiratory tract, skin, and eyes
Skin Sensitization: Potential sensitizer with repeated contact
Eye Damage/Irritation: May cause redness and discomfort
Specific Target Organ Toxicity: Central nervous system, liver, kidneys
Carcinogenicity: No data available for long-term exposure at industrial levels
Signal Word: Caution advised for all chemical handling
Hazard Statements: May be harmful if swallowed or inhaled, can cause allergic reactions in sensitive individuals

Composition / Information on Ingredients

Chemical Identity: Mirtazapine Anhydrous
Concentration: 100% active ingredient
Impurities and Additives: None declared (high purity raw material)
Other Names: None relevant for safety assessment

First Aid Measures

Inhalation: Remove person to fresh air, provide oxygen if breathing is difficult, seek medical attention if symptoms persist
Skin Contact: Remove contaminated clothing, wash exposed area with soap and water for at least 15 minutes, do not reuse contaminated clothing
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present, continue rinsing, obtain medical aid if irritation develops
Ingestion: Rinse mouth with water, do not induce vomiting, seek immediate medical attention (as symptoms may include drowsiness, confusion, low blood pressure)
Important Symptoms: Nausea, drowsiness, confusion, skin or mucous membrane irritation
Medical Attention/Special Treatment: Symptomatic and supportive treatment recommended, monitor for CNS and hepatic effects

Fire-Fighting Measures

Suitable Extinguisher Media: Water spray, carbon dioxide, dry chemical powder, foam
Unsuitable Media: Do not use water jet directly on material pile
Specific Hazards: Toxic fumes possible under combustion, including nitrogen oxides and carbon monoxide
Protective Equipment: Firefighters should wear self-contained breathing apparatus and fully protective gear
Evacuation Procedures: Remove all personnel not involved in fire-fighting, keep upwind
Special Precautions: Cool containers with water spray to prevent heat exposure, avoid runoff into drains and waterways

Accidental Release Measures

Personal Precautions: Avoid dust formation and inhalation, use suitable personal protective equipment such as gloves, goggles, and approved respirators
Environmental Precautions: Prevent contamination of soil and water, avoid discharge to drains
Methods for Cleaning Up: Scoop up spilled powder using non-sparking tools, place in labeled container for disposal, wash area with water after cleaning
Spill Response: Ventilate area, avoid raising dust, keep unauthorized personnel away until clean-up complete

Handling and Storage

Handling: Work in well-ventilated area, avoid breathing dust, avoid contact with eyes and skin, use with appropriate engineering controls
Storage: Store in tightly closed containers in a cool, dry, well-ventilated area, keep away from incompatible substances such as strong oxidizing agents
Safe Transfer Techniques: Use tools and containers that minimize dust generation, ground containers when transferring large amounts
Hygiene Practices: Wash hands thoroughly after handling, do not eat, drink or smoke in work areas
Incompatible Materials: Strong acids, bases, and oxidizers

Exposure Controls and Personal Protection

Occupational Exposure Limits: No established occupational exposure limit for mirtazapine, maintain dust levels as low as possible
Respiratory Protection: Use NIOSH-approved dust respirators or suitable alternatives when dust exposure exceeds safe levels
Skin Protection: Wear chemical-resistant gloves and laboratory coats
Eye Protection: Use safety goggles or face shields
Engineering Controls: Use local exhaust ventilation, fume hoods, or dust extraction devices
Environmental Controls: Implement closed systems where feasible, monitor work area for airborne particles

Physical and Chemical Properties

Physical State: Solid (powder or crystalline)
Color: White to off-white
Odor: Odorless
Melting Point: 114–115°C
Boiling Point: Decomposition before boiling
Solubility: Slightly soluble in water, soluble in methanol and ethanol
pH: Not available (neutral to weakly alkaline in water)
Vapor Pressure: Negligible at room temperature
Partition Coefficient: LogP ~2.9
Flash Point: Not flammable under standard test conditions
Other Properties: Stable under normal handling conditions, dust may form explosive mixtures with air in rare case of fine dispersion and spark presence

Stability and Reactivity

Chemical Stability: Stable under normal temperatures and pressures
Reactivity: Chemically inert to most substances in lab-scale conditions
Hazardous Polymerization: Will not occur
Decomposition Products: Nitrogen oxides, carbon monoxide, carbon dioxide may form at high temperature
Incompatible Materials: Strong oxidizing agents, strong acids or bases
Conditions to Avoid: Excessive heat, open flames, formation of dust clouds

Toxicological Information

Acute Toxicity: May cause drowsiness, confusion, low blood pressure, tachycardia
Chronic Toxicity: No confirmed long-term effects in workplace exposure, long-term animal studies suggest potential for mild liver enzyme changes at high doses
Irritation: Eyes, respiratory tract, and skin may become irritated upon contact
Sensitization: Rare instances of skin sensitization in research settings
Mutagenicity: Results show no significant mutagenic effects in bacterial testing
Reproductive Toxicity: No specific data for raw material, prescription form carries warning for use in pregnancy
Carcinogenicity: Not listed as a carcinogen by IARC, NTP, or OSHA

Ecological Information

Ecotoxicity: Potential for toxicity to aquatic organisms at high concentrations, no large-scale data for environmental persistence
Persistence/Degradability: Material expected to be moderately persistent, poorly biodegradable
Bioaccumulation Potential: Low to moderate, based on octanol-water partition coefficient
Mobility in Soil: Moderate mobility
Water Contamination Risk: Do not allow undiluted material to reach groundwater or water bodies
Special Precautions: Dispose of in accordance with local environmental regulations, avoid bulk disposal in sewage or natural waters

Disposal Considerations

Waste Disposal Methods: Treat as hazardous laboratory waste, incinerate or dispose via licensed chemical waste contractor
Contaminated Packaging: Dispose of in accordance with national and local regulations, thoroughly rinse and destroy containers before disposal
Disposal Restrictions: Avoid landfill dumping, environmental discharge, and uncontrolled burning
Local Requirements: Follow all specific chemical waste handling guidelines for pharmaceuticals

Transport Information

UN Number: Not classified as hazardous for transport under UN regulations
Proper Shipping Name: Not regulated for land, sea, or air transport
Transport Hazard Class: Non-hazardous
Packing Group: Not applicable
Special Precautions: Store and transport in sealed containers, avoid exposure to moisture and direct sunlight
Labels: Not required for non-bulk quantities under IATA/IMDG/ADR
Additional Transport Instructions: Maintain documentation identifying as pharmaceutical intermediate or reference standard

Regulatory Information

OSHA Status: Not specifically regulated as hazardous
TSCA (United States): Not listed for general industrial use
EINECS / ELINCS: Not listed
RCRA (Hazardous Waste): Not classified as hazardous waste; treat as chemical waste
Other US Regulations: Review federal, state and local requirements for regulated substances
International Regulations: Not subject to stringent restrictions by REACH or similar regimes in its raw form
Pharmaceutical Control: Prescription pharmaceutical with usage limits under FDA/EMA guidelines when processed as a medicine
Workplace Hazard Labels: Recommended to use warning labels for laboratory quantities