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Material Safety Data Sheet of Memantine Hydrochloride

Identification

Product Name: Memantine Hydrochloride
Chemical Name: 1-Amino-3,5-dimethyladamantane hydrochloride
Synonyms: 1-Aminoadamantane hydrochloride, Namenda
Molecular Formula: C12H21N·HCl
Molecular Weight: 215.76 g/mol
CAS Number: 41100-52-1
Manufacturer/Supplier: Pharmaceutical and chemical distributors, see product label
Recommended Use: Active pharmaceutical ingredient for neurodegenerative diseases
Contact Information: Customer support number and address as given by supplier
Emergency Telephone: Local Poison Control Center, or supplier emergency response

Hazard Identification

GHS Classification: Not classified as hazardous under GHS criteria for most jurisdictions
Signal Word: None
Hazard Statements: No significant hazards identified at normal conditions. Irritation may develop with prolonged or repeated exposure to dust.
Precautionary Statements: Avoid contact with eyes, skin, and clothing. Prevent inhalation of dust or mist. Use proper personal protective equipment.
Potential Health Effects: Irritation to eyes, skin, or respiratory tract. Ingestion may cause gastrointestinal discomfort or neurologic symptoms at significant doses.
Environmental Hazards: Limited data, do not release to environment without control.

Composition / Information on Ingredients

Chemical Identity: Memantine Hydrochloride
Concentration: 99–100% pure (pharmaceutical grade)
Impurities: Trace level residual solvents and starting materials, typically below standard safety thresholds
Additives: None reported

First Aid Measures

Inhalation: Move person to fresh air. Seek medical attention if symptoms persist such as coughing or respiratory distress.
Skin Contact: Wash area with plenty of water and mild soap. Remove contaminated clothing. Get medical advice if irritation develops.
Eye Contact: Rinse eyes thoroughly under running water for several minutes holding eyelids open. Remove contact lenses if present. Contact physician if discomfort continues.
Ingestion: Rinse mouth with water. Do not induce vomiting unless advised. Seek medical attention if large quantity ingested or if symptoms develop.
Notes for Doctor: Treatment should be symptomatic and supportive.

Fire-Fighting Measures

Suitable Extinguishing Media: Water fog, foam, dry chemical, or carbon dioxide
Unsuitable Media: Direct water stream may spread powder
Specific Hazards: Dust may form explosive mixtures with air. Combustion may produce toxic fumes including nitrogen oxides, hydrogen chloride gas, carbon monoxide.
Protective Equipment for Firefighters: Self-contained breathing apparatus (SCBA) and full protective suit
Special Precautions: Prevent water runoff from entering drains or waterways.

Accidental Release Measures

Personal Precautions: Wear gloves, goggles, and respiratory protection in poorly ventilated settings.
Environmental Precautions: Avoid uncontrolled release. Prevent material from entering drains, surface water, or soil.
Cleanup Methods: Avoid dust formation. Scoop or vacuum material into suitable containers for disposal. Clean spill area with detergent and water.
Disposal: Dispose of as hazardous pharmaceutical waste in accordance with local regulations.

Handling and Storage

Handling Recommendations: Work in well-ventilated area, use protective equipment. Avoid generating dust. Keep away from food and beverages.
Storage Conditions: Store tightly sealed in original container in cool, dry, and well-ventilated location, away from light and incompatible substances.
Incompatibilities: Strong oxidizers, acids, alkalis
Hygiene Practices: Wash hands thoroughly after handling; remove contaminated clothing.

Exposure Controls and Personal Protection

Engineering Controls: Use local exhaust ventilation or process enclosures to limit airborne dust.
Exposure Limits: No occupational exposure limits set for Memantine Hydrochloride. Use pharmaceutical exposure control banding as appropriate.
Respiratory Protection: NIOSH-approved particulate respirator under conditions of dust or aerosol formation.
Eye/Face Protection: Safety goggles or face shield
Skin Protection: Protective gloves (nitrile, latex) and lab coat
Other Protection: Wash hands after use and before breaks; avoid contact with skin and eyes.

Physical and Chemical Properties

Appearance: White or off-white crystalline powder
Odor: Odorless
Odor Threshold: Not available
pH: 5.0–6.5 (1% solution in water)
Melting Point/Range: 292–295°C (decomposes)
Boiling Point: Not applicable, decomposes before boiling
Flash Point: Not applicable
Evaporation Rate: Not applicable
Flammability: Not classified as flammable
Explosion Limits: Not established
Vapor Pressure: Not applicable
Vapor Density: Not applicable
Solubility in Water: Freely soluble
Partition Coefficient (n-octanol/water): Not available
Auto-ignition Temperature: Not known
Decomposition Temperature: Above melting point
Viscosity: Not applicable

Stability and Reactivity

Chemical Stability: Stable under normal handling and storage conditions
Reactivity: Low chemical reactivity under standard conditions
Conditions to Avoid: Exposure to moisture, heat, and strong light
Incompatible Materials: Strong oxidizing agents, acids, alkali metals
Hazardous Decomposition Products: Hydrogen chloride, nitrogen oxides, carbon monoxide/carbon dioxide
Polymerization: Will not undergo hazardous polymerization

Toxicological Information

Acute Toxicity: Low oral acute toxicity in animal studies; human toxicity typically associated with overdose
Potential Routes of Exposure: Inhalation, skin and eye contact, ingestion
Symptoms of Exposure: Respiratory tract, eye, skin irritation; large dose ingestion may cause neurotoxicity (confusion, agitation, ataxia, seizures)
Chronic Effects: Repeated doses may affect central nervous system
Carcinogenicity: No evidence of carcinogenicity according to current studies
Mutagenicity/Teratogenicity: Negative in standard genotoxicity tests; animal fertility studies show low risk
Target Organs: Central nervous system
Medical Conditions Aggravated by Exposure: Pre-existing neuropsychiatric conditions

Ecological Information

Ecotoxicity: Environmental information limited. Not expected to bioaccumulate or significantly impact aquatic life at typical low concentrations.
Persistence and Degradability: Likely to degrade over time, details not fully characterized
Bioaccumulative Potential: Low, based on chemical structure
Mobility in Soil: Soluble in water may allow limited migration through soil and water systems
Other Adverse Effects: Avoid release to surface waters and public sewers

Disposal Considerations

Waste Treatment Methods: Dispose of waste material according to local, regional, or national regulations for pharmaceutical waste.
Contaminated Packaging: Dispose of in accordance with government environmental control regulations
Disposal Precautions: Do not discharge to drains, soil, or environment
Special Considerations: Consult authorized waste management professionals for proper disposal methods

Transport Information

UN Number: Not regulated
Proper Shipping Name: Not regulated for transport by ground, sea, or air
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Environmental Hazards: Not a marine pollutant
Special Precautions for User: Use leak-proof and properly labeled containers, secure packaging to prevent release
Transport in Bulk: Not relevant for this product in pharmaceutical settings

Regulatory Information

Safety, Health and Environmental Regulations: Not classified as hazardous under U.S. OSHA, EU REACH, or other major regulatory frameworks
Inventory Listings: Present on chemical substance inventories in several regions (e.g., TSCA, EINECS/ELINCS)
Other Requirements: Pharmaceutical products subject to drug control and prescription regulations
Labeling Requirements: Follow national and regional labeling guidelines for laboratory chemicals and pharmaceuticals
Other Regulatory Notes: Ensure compliance with local legislation regarding safe handling and disposal of pharmaceutical chemicals