Material Safety Data Sheet: Levosalbutamol Tartrate

Identification

Product Name: Levosalbutamol Tartrate
Chemical Name: (R)-1-(4-hydroxy-3-hydroxy methylphenyl)-2-(tert-butylamino)ethanol tartrate
Synonyms: Levalbuterol Tartrate, (R)-Salbutamol Tartrate
CAS Number: 138-71-0
Recommended Use: Pharmaceutical active ingredient for respiratory and asthma medication
Manufacturer: [Company information specific to your organization]
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Hazard Identification

Classification according to GHS: Acute Toxicity (Oral) Category 4, Skin Irritation Category 2, Eye Irritation Category 2, Specific Target Organ Toxicity (Single Exposure) Category 3
Label Elements: Signal Word: Warning, Hazard Statements: May cause respiratory irritation, may cause moderate eye/skin irritation, harmful if swallowed
Health Hazards: Inhalation can irritate lungs and airways, contact with eyes or skin may cause redness or pain, ingestion may provoke nausea, headache, tremors, anxiety
Environmental Hazards: May be hazardous to aquatic organisms if spilled in large quantities
Precautionary Statements: Avoid breathing dust, wear gloves and eye protection, wash hands thoroughly after handling

Composition / Information on Ingredients

Chemical: Levosalbutamol tartrate
CAS Number: 138-71-0
Formula: C13H21NO3·C4H6O6
Concentration: Pure substance or as specified on label
Impurities: Trace organic and inorganic impurities may be present depending on the synthesis method

First Aid Measures

Inhalation: Move the exposed person to fresh air, keep comfortable for breathing, seek medical attention if symptoms persist
Skin Contact: Wash with soap and plenty of running water, remove contaminated clothing, seek medical advice if irritation develops
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present and easy to do, continue rinsing, get medical help if irritation remains
Ingestion: Rinse mouth with water, do not induce vomiting, seek immediate medical advice, keep patient at rest and monitor breathing and pulse

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or foam
Specific Hazards: Burning creates toxic fumes including nitrogen oxides and carbon monoxide
Special Protective Equipment for Firefighters: Wear full protective suit and self-contained breathing apparatus, avoid inhaling combustion products
Fire/Explosion Hazards: Dust can form explosive mixtures in air, cool exposed containers with water spray

Accidental Release Measures

Personal Precautions: Evacuate area, wear protective gloves, goggles, and dust mask, avoid creating or inhaling dust
Environmental Precautions: Prevent release into drains, surface water, or soil, notify authorities if contamination occurs
Methods for Clean-Up: Sweep up with care to avoid dust, place in labeled waste containers, ventilate area and wash spill site after pickup is complete

Handling and Storage

Handling: Avoid contact with skin and eyes, minimize dust formation, use in well-ventilated areas, wear appropriate PPE
Storage: Store in tightly closed container, in a cool dry place away from sunlight and incompatible substances, keep out of reach of children

Exposure Controls and Personal Protection

Control Parameters: No established occupational exposure limits for Levosalbutamol tartrate, use standard pharmaceutical laboratory controls
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to maintain airborne levels below recommended exposure guidelines
Personal Protective Equipment: Respirator if ventilation is inadequate, chemical-resistant gloves, safety goggles, lab coat, good hygiene practices including hand washing after handling the material

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless or very faint odor
Boiling Point: Not available
Melting Point: Approximately 176–178°C
Solubility: Freely soluble in water, sparingly soluble in ethanol
pH (1% solution): 3.5–4.5
Vapor Pressure: Not significant at room temperature
Density: Not determined
Stability: Stable under normal conditions; sensitive to heat, light, and moisture

Stability and Reactivity

Chemical Stability: Stable under normal storage and handling conditions
Conditions to Avoid: Exposure to elevated temperatures, strong light, moisture
Incompatible Materials: Strong acids, strong bases, oxidizing and reducing agents
Hazardous Decomposition Products: May produce carbon monoxide, carbon dioxide, nitrogen oxides under fire conditions
Polymerization: Will not occur under standard handling and storage

Toxicological Information

Acute Toxicity: LD50 (Oral, Rat) has been reported in ranges 600–900 mg/kg for closely related substances
Routes of Exposure: Inhalation, ingestion, skin, and eye contact
Symptoms: Headache, tremors, agitation, rapid heartbeat, dizziness, possible gastrointestinal disturbance
Chronic Effects: Long-term use may affect cardiovascular and central nervous system, especially at high therapeutic doses
Carcinogenicity: No evidence of carcinogenic potential in animal studies
Mutagenicity: No confirmed mutagenic effect
Reproductive Toxicity: No adequate studies available for human reproductive impact

Ecological Information

Toxicity: Data insufficient; avoid uncontrolled environmental release
Persistence and Degradability: May be slowly degraded in the environment; avoid discharge to waterways
Bioaccumulative Potential: Not expected to bioaccumulate
Mobility in Soil: Likely to be mobile in water and soil due to high solubility
Additional Information: Dispose with care to prevent ecological damage

Disposal Considerations

Waste Disposal Methods: Dispose of in accordance with local, regional, and national regulations for hazardous pharmaceutical waste
Contaminated Packaging: Treat as hazardous chemical waste; triple rinse and dispose of through a permitted waste handler
Sewage Disposal: Do not dispose of product or contaminated rinsewater via drains

Transport Information

UN Number: Not classified as dangerous goods for transport by ADR/RID/IMDG/IATA
Proper Shipping Name: Not regulated
Hazard Class: Not regulated
Packing Group: Not regulated
Special Precautions: Ensure containers remain tightly sealed during transport, protect from mechanical and chemical damage

Regulatory Information

Safety, Health, and Environmental Regulations: Subject to specific medical and pharmaceutical control regulations in applicable jurisdictions
Inventory Status: Not listed on major global chemical inventories as it is a pharmaceutical active ingredient
Restrictions: Production, handling, and distribution regulated for pharmaceutical use only
Labelling Requirements: Comply with national and international hazardous substance labeling standards