Product Name: Levalbuterol Tartrate
Synonyms: (R)-Albuterol Tartrate, Xopenex
Chemical Formula: C13H21NO3·C4H6O6
CAS Number: 857064-38-1
Molecular Weight: 628.64 g/mol
Recommended Use: Pharmaceutical bronchodilator for asthma treatment
Manufacturer Contact: Medical information department, emergency contact number available 24 hours
Emergency Phone: Refer to specific local regulations and company resources for current emergency contacts
Usage Restrictions: Prescription medication, not for use outside the guidelines of licensed health professionals
Classification: Eye Irritant, Possible Sensitizer, Not classified as a carcinogen under IARC
Physical Hazards: May cause irritation on direct exposure; not flammable but may emit toxic fumes under fire
Health Hazards: Inhalation may trigger breathing difficulties for sensitive individuals; accidental ingestion can induce nausea, nervousness, tremor, palpitations
Environmental Hazards: Potential to affect aquatic environments at large spills; not persistent or bioaccumulative by routine waste disposal evidence
Active Ingredient: Levalbuterol Tartrate
Concentration: Typically supplied as a sterile solution, 0.31 mg, 0.63 mg, or 1.25 mg per 3 mL unit dose
Other Ingredients: Sodium chloride, hydrochloric acid (for pH adjustment), water for injection
Impurities: Not expected at concentrations associated with hazard; purity confirmed by pharmaceutical standards
Ingredient Type: Single active substance with excipients for inhalation use
Inhalation: Remove exposed individual to fresh air, monitor for respiratory distress, seek medical help if breathing difficulty persists
Skin Contact: Clean with mild soap and water, remove contaminated clothing, monitor for irritation
Eye Contact: Rinse with flowing lukewarm water for a least 15 minutes, keep eyelids open, seek medical attention if symptoms develop
Ingestion: Rinse mouth, offer small amounts of water, do not induce vomiting, obtain immediate medical advice in case of large exposure or persistent symptoms
Notes to Physician: Treat symptomatically; monitor cardiac and respiratory functions
Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, foam
Unsuitable Media: None known for residual pharmaceutical forms
Special Hazards: Decomposition releases carbon oxides, nitrogen oxides, possible toxic fumes
Protective Equipment: Firefighters wear self-contained breathing apparatus and full-body protective gear
Firefighting Tips: Cool containers with water to reduce pressure build-up, avoid inhalation of hazardous combustion products
Personal Precautions: Isolate spill area, ventilate room, use gloves and protective eyewear
Spill Response: Absorb with inert material (sand, vermiculite), sweep into appropriate waste containers
Decontamination: Clean residue with water and detergent
Environmental Precautions: Prevent entry into waterways, drains, or soil; report large spills to environmental authorities
Methods for Disposal: Dispose of according to official pharmaceutical hazardous waste procedures
Handling: Use in well-ventilated areas, avoid inhalation and contact with skin or eyes, keep containers tightly closed
Storage Conditions: Store at 20°C-25°C, protect from excessive heat and light, keep away from incompatible materials, keep container upright
Incompatibilities: Strong oxidants, mineral acids, bases
Hygienic Practices: Wash hands thoroughly after handling, remove contaminated clothing before entering break areas
Engineering Controls: Local exhaust ventilation or general room ventilation, fume hoods for bulk handling
Eye Protection: Chemical splash goggles
Skin Protection: Conflict-free nitrile or latex gloves, disposable lab coats or gowns
Respiratory Protection: Not typically required at therapeutic doses, NIOSH-approved respirators for bulk powder
Occupational Exposure Limits: No OSHA PEL or ACGIH TLV; control exposure based on pharmaceutical industry guidelines
Appearance: White to off-white crystalline solid or clear solution
Odor: Odorless
pH (of solution): 4.0-5.2 (in aqueous solution)
Solubility: Freely soluble in water
Melting Point: About 187°C
Boiling Point: Not applicable for pharmaceutical solution
Flash Point: Not highly flammable
Density: Not reported; typically matches water for solution
Partition Coefficient: Not available; generally low for ionic compounds
Vapor Pressure: Negligible in standard conditions
Viscosity: Comparable to water
Chemical Stability: Stable under recommended storage conditions
Reactivity: Non-reactive in normal pharmaceutical handling
Conditions to Avoid: Heat, light, moisture, incompatible substances such as strong acids or oxidizers
Hazardous Decomposition Products: Carbon dioxide, carbon monoxide, nitrogen oxides, smoke
Polymerization: Not known to occur
Acute Toxicity: Oral LD50 (rat): > 2000 mg/kg (active component, estimated)
Chronic Effects: Prolonged exposure to large doses may cause tremor, rapid heart rate, nervousness
Skin/Eye Contact: Possible mild irritation
Inhalation: Bronchodilator action; high doses can trigger paradoxical bronchospasm
Sensitization: No reliable evidence from clinical use patterns
Carcinogenicity: Animal studies show no increased risk, not considered carcinogenic by regulatory authorities
Reproductive Toxicity: Not considered teratogenic at therapeutic doses
Ecotoxicity: Not classified as environmentally hazardous, though large quantities may harm aquatic organisms
Persistence: Expected to break down under environmental conditions
Bioaccumulation: Not likely to bioaccumulate based on chemical structure and water solubility
Mobility: High mobility in water due to solubility
Degradability: Degrades over time by normal environmental processes
Disposal Methods: Incinerate in approved facility or dispose as hazardous waste according to local regulations
Container Disposal: Triple rinse empty containers, render unusable, follow pharmaceutical waste program
Regulatory Considerations: Comply with local, state, and federal hazardous waste laws
UN Number: Not regulated for transport
Proper Shipping Name: Medicine, not otherwise specified
Transport Hazard Class: Not classified as dangerous for conveyance
Packing Group: Not applicable
Special Precautions: Protect from physical damage; avoid temperature extremes during shipment
US Regulations: FDA-approved prescription drug, not subject to TSCA; meets requirements under OSHA Hazard Communication Standard for pharmaceutical workplaces
International Inventories: Included in appropriate international medicinal registries
Classification: Non-hazardous under UN GHS for retail end-user
Labeling Requirements: Medical supervision required; labeled per prescription standards
Other Requirements: Subject to DEA control in some countries; state and local laws may impose additional rules for possession and distribution
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