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Material Safety Data Sheet: Neostigmine Methylsulfate

Identification

Product Name: Neostigmine Methylsulfate
Chemical Name: 3-[1-(Dimethylamino)propan-2-yl]phenyl N-methylcarbamate methyl sulfate
Synonyms: Prostigmin Methylsulfate
CAS Number: 51-60-5
Recommended Use: Pharmaceutical applications in anesthesia, myasthenia gravis management, reversal of nondepolarizing neuromuscular blocking agents
Supplier: Pharmaceutical manufacturer or medical supplier
Emergency Contact: Local poison control center or emergency medical services

Hazard Identification

GHS Classification: Acute Toxicity (Oral, Dermal, Inhalation), Serious Eye Damage/Irritation, Specific Target Organ Toxicity
Signal Word: Danger
Hazard Statements: Toxic if swallowed, harmful if inhaled, causes serious eye damage, may cause allergic skin reaction
Pictograms: Skull and crossbones, exclamation mark, health hazard
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Target Organs: Nervous system, respiratory system, muscles

Composition / Information on Ingredients

Chemical Name: Neostigmine Methylsulfate
Concentration: Pure or as specified on product labeling, often presented as a sterile solution
CAS Number: 51-60-5
Impurities or Stabilizers: May contain water for injection, sodium chloride, or preservatives in pharmaceutical preparations
Additive Ingredients: Occasionally combined with other injectable agents for hospital use

First Aid Measures

Inhalation: Move affected person to fresh air, keep at rest, seek immediate medical attention for respiratory symptoms
Skin Contact: Remove contaminated clothing, wash exposed area with soap and water, consult physician if irritation develops
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present, seek immediate medical advice for persistent effects
Ingestion: Rinse mouth, do not induce vomiting, seek urgent medical evaluation; observe for muscle weakness, troubled breathing, bradycardia
Most Important Symptoms: Salivation, sweating, muscle twitching, breathing discomfort, bradycardia, convulsions
Special Instructions: Immediate medical intervention required due to rapid onset of cholinergic toxicity

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical, foam
Unsuitable Extinguishing Media: Direct water jet
Specific Hazards Arising: Releases toxic fumes of nitrogen oxides, sulfur oxides, and carbon oxides when heated or involved in fire
Protective Equipment: Self-contained breathing apparatus and full protective clothing, avoid inhalation of smoke or vapors
Special Procedures: Cool containers with water spray to prevent rupture, evacuate area; prevent runoff from contaminating water resources

Accidental Release Measures

Personal Precautions: Avoid dust, vapor, or mist exposure; ventilate area; use gloves, goggles, and protective clothing
Environmental Precautions: Prevent further leakage or spillage; avoid discharge into drains, surface water, or soil
Cleaning Methods: Absorb spill with inert material such as dry sand or earth, scoop up and place in a suitable sealed, labeled container for disposal
Decontamination: Wash spill site with soap and water after clean-up
Notification: Report large releases to appropriate local authorities based on local regulations

Handling and Storage

Safe Handling: Minimize dust generation, avoid contact with eyes, skin, and clothing; use only in well-ventilated areas
Hygiene Measures: Wash hands thoroughly after handling, no eating, drinking, or smoking in work area
Storage Conditions: Store in original tightly closed container, protected from light, at recommended controlled temperature (often 15–30°C/59–86°F)
Incompatibilities: Keep away from strong oxidizing agents, bases, acids
Special Storage: Store locked up in designated medicines cabinet, away from unauthorized personnel, children, or animals

Exposure Controls and Personal Protection

Engineering Controls: Use local exhaust ventilation, fume hood, or other controls to minimize exposure
Respiratory Protection: Suitable face mask or respirator for airborne concentrations above safe limits
Skin Protection: Protective gloves made of nitrile or latex
Eye Protection: Safety goggles or face shield
Other Protection: Laboratory coat, long sleeves, avoid skin exposure, emergency eye wash and safety shower nearby
Exposure Limits: Not established by OSHA or ACGIH for active ingredient, attention to threshold limit values for related cholinesterase inhibitors

Physical and Chemical Properties

Physical State: Solid (in pure form), clear colorless solution (in injectable product)
Color: White or off-white (solid); colorless (solution)
Odor: Odorless or faint characteristic odor
Molecular Formula: C13H22N2O6S
Molecular Weight: 342.39 g/mol
pH (for solution): 5.5–7.0
Melting Point: Decomposes above 150°C
Boiling Point: Not applicable (decomposition before boiling)
Solubility: Freely soluble in water, sparingly soluble in ethanol
Partition Coefficient: LogP < 0
Vapor Pressure: Not significant at room temperature

Stability and Reactivity

Stability: Stable under normal conditions when stored as recommended
Conditions to Avoid: Excessive heat, direct sunlight, moisture
Materials to Avoid: Strong oxidizing agents, strong acids and bases
Hazardous Decomposition: Nitrogen oxides, carbon oxides, sulfur oxides, toxic fumes
Hazardous Polymerization: Will not occur in normal pharmaceutical formulations

Toxicological Information

Acute Toxicity: LD50 (oral, rat) approximately 28 mg/kg; high toxicity for therapeutic class
Chronic Effects: Possible cumulative cholinergic effects with repeated exposure
Irritation: May cause eye irritation, skin reactions
Sensitization: Allergic symptoms including rash, difficulty breathing reported in rare cases
Carcinogenicity: Not classified as carcinogen by IARC, NTP, OSHA
Reproductive Effects: Not fully studied; use caution, especially during pregnancy
Symptoms of Exposure: Vomiting, diarrhea, muscle cramps, miosis, respiratory depression, convulsions

Ecological Information

Aquatic Toxicity: Likely toxic to aquatic organisms even in small amounts due to potent biological activity
Persistence and Degradability: Expected to degrade slowly; persistent in water and soil if released
Bioaccumulation Potential: Not expected to bioaccumulate in aquatic organisms
Mobility in Soil: Readily dissolves and may migrate in surface and groundwater
Other Adverse Effects: Potential risk to wastewater bacteria, aquatic ecosystems

Disposal Considerations

Waste Treatment Methods: Incinerate in approved facility; follow federal, state, and local regulations
Unused Product: Dispose as hazardous pharmaceutical waste
Contaminated Packaging: Dispose of as hazardous waste or return to supplier for safe disposal
Environmental Precautions: Avoid dispersal into environment, do not allow entry into sewers or waterways
Regulatory Compliance: Consult official guidelines before disposal, avoid municipal waste routes

Transport Information

UN Number: UN2811 (for toxic solids, organic, n.o.s., in bulk transport)
DOT Shipping Name: Toxic solid, organic, n.o.s. (Neostigmine Methylsulfate)
Transport Hazard Class: 6.1 (Toxic substances)
Packing Group: II
Label Requirements: Toxics label
Special Precautions: Secure packaging, avoid breakage, use secondary containment when shipping bulk quantities
Road, Air, Sea Transport: Must comply with regulations from ICAO/IATA, IMDG, ADR/RID

Regulatory Information

United States: Controlled under the Federal Food, Drug, and Cosmetic Act; hazardous substance under OSHA Hazard Communication Standard
Canada: Regulated as prescription drug product
Europe: Subject to European Medicines Agency and REACH regulations
Inventory Status: Not listed on TSCA inventory, only for approved medical use
Risk Phrases: R25—Toxic if swallowed; R36/37/38—Irritating to eyes, respiratory system, skin
SARA/Title III: Not reportable for SARA 302/313
Customs Requirements: Pharmaceutical import/export restrictions, controlled movement