Product Name: Brimonidine Tartrate
Chemical Name: 5-bromo-6-(2-imidazolin-2-ylamino)quinoxaline tartrate
Synonyms: Alphagan, UK 14304 tartrate
CAS Number: 70359-46-5
Recommended Use: Pharmaceutical ingredient, usually as an ocular antihypertensive
Supplier: Prescription and compounding pharmacies, pharmaceutical distributors
Contact Information: Emergency phone numbers and manufacturer contact available on product packaging
Classification: May cause skin irritation, eye irritation, and respiratory tract irritation. Harmful if swallowed.
Signal Word: Warning
Hazard Statements: Causes mild to moderate eye irritation. May cause allergic skin reactions or respiratory symptoms. Harmful to aquatic organisms with long-term effects.
Precautionary Statements: Use personal protective equipment. Avoid contact with eyes, skin, and clothing. Avoid release into the environment. Wash thoroughly after handling.
Pictograms: Exclamation mark for irritant
Possible Routes of Exposure: Inhalation, skin absorption, eye contact, ingestion
Chemical Substance: Brimonidine Tartrate
Concentration: Typically 100% (for raw material), in pharmaceuticals typically less than 1% w/v aqueous solution
Impurities and Stabilizers: Trace solvents or process residuals depending on supplier, not typically present above regulatory thresholds
Molecular Formula: C11H10BrN5•C4H6O6
Molecular Weight: 442.24 g/mol
Inhalation: Move person to fresh air. Seek medical attention if symptoms develop.
Skin Contact: Wash thoroughly with soap and water. Remove contaminated clothing. Seek medical attention for persistent irritation.
Eye Contact: Rinse eyes with water for at least 15 minutes. Remove contact lenses if present. Seek medical advice if irritation persists.
Ingestion: Rinse mouth with water. Never give anything by mouth to an unconscious person. Get medical help if symptoms appear.
Acute Symptoms: Irritation, headache, dizziness, drowsiness, allergic reactions in sensitive individuals
Suitable Extinguishing Media: Use water spray, carbon dioxide, dry powder, or foam.
Specific Hazards: Decomposes above 200°C, releasing toxic fumes such as nitrogen oxides, bromine compounds, carbon monoxide, carbon dioxide.
Protective Equipment: Firefighters wear self-contained breathing apparatus and full protective clothing.
Emergency Procedures: Eliminate all ignition sources. Ventilate area.
Hazardous Combustion Products: Smoke, toxic vapors, irritating gases
Personal Precautions: Avoid contact with skin and eyes. Use proper personal protection including gloves, eyewear, and respirator if dust forms.
Environmental Precautions: Prevent further leakage or spillage if safe. Avoid entry into water streams, sewers, or confined spaces.
Methods for Cleanup: Collect spillage with non-combustible absorbent material (e.g., sand, earth, diatomaceous earth). Dispose in suitable waste containers. Clean contaminated surface thoroughly.
Emergency Procedures: Isolate hazard area. Ventilate spill area.
Safe Handling: Work in well-ventilated areas. Use closed systems, local exhaust, or respiratory protection. Avoid generation and inhalation of dust/mist.
Storage Requirements: Store in tightly closed original container in a cool, dry, well-ventilated area, away from acids, oxidizing agents, and direct sunlight.
Temperature Recommendations: Store at room temperature (20–25°C). Avoid excessive heat or freezing.
Other Information: Keep out of reach of children. Label all containers clearly and keep secure from unauthorized access.
Occupational Exposure Limits: No specific limits established for Brimonidine Tartrate; handle based on general pharmaceutical chemical standards.
Engineering Controls: Use fume hood, local exhaust, and process enclosure as appropriate.
Personal Protective Equipment: Wear protective gloves (nitrile or latex), safety goggles, and laboratory coat. Use dust mask or respirator if handling fine powder.
Hygiene Measures: Wash hands after handling; do not eat, drink, or smoke in processing areas. Remove and wash contaminated clothing.
Environmental Controls: Prevent material from entering drains or surface water.
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH: 4.5-6.5 (1% solution in water)
Melting Point: 206–210°C (decomposes)
Boiling Point: Not determined (decomposes)
Density: Approx. 1.6 g/cm³
Solubility: Freely soluble in water and ethanol
Partition Coefficient (log Pow): Not determined
Vapor Pressure: Negligible at room temperature
Stability: Stable under normal storage conditions, sensitive to extreme heat and moisture
Chemical Stability: Stable under recommended storage conditions at room temperature and away from moisture.
Conditions to Avoid: High temperatures, exposure to moisture, light, and acidic or basic conditions.
Incompatible Materials: Strong oxidizers, strong acids, strong bases
Hazardous Decomposition Products: Nitrogen oxides, carbon dioxide, carbon monoxide, bromine compounds
Reactivity: Not chemically reactive under normal handling conditions
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Toxicity: LD50 (oral, rat): 50–250 mg/kg (estimated from animal data)
Chronic Effects: Repeated exposure can cause skin sensitization, respiratory irritation, possible CNS effects (drowsiness, dizziness).
Symptoms of Exposure: Headache, dizziness, drowsiness, skin and eye irritation
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, or OSHA
Mutagenicity/Teratogenicity: No evidence in standard tests
Additional Information: Limited data on long-term human exposure; use caution
Aquatic Toxicity: Harmful to aquatic life with long-lasting effects (based on chemical structure and pharmaceutical data)
Persistence and Degradability: Not readily biodegradable; may persist in environment
Bioaccumulative Potential: Data lacking, low potential expected due to water solubility
Mobility in Soil: Highly mobile in water, potential to leach into groundwater
Other Adverse Effects: Avoid environmental release as a pharmaceutical pollutant; impacts wastewater treatment processes
Product Disposal: Dispose through licensed chemical waste disposal contractor, following local, regional, and national regulations.
Container Disposal: Triple rinse, then dispose in accordance with hazardous waste requirements.
Precautions: Do not discharge into drains, soil, or water bodies. Incinerate in approved facility if possible.
Special Instructions: Follow institutional or municipal guidelines for pharmaceutical or hazardous chemical disposal.
UN Number: Not regulated for transport under international agreements
UN Proper Shipping Name: Not regulated
Transport Hazard Class: Not classified as dangerous for road, sea, or air transport
Packing Group: Not applicable
Special Precautions: Prevent spills and keep tightly sealed during transport. Protect package from moisture, direct sunlight, and heat.
US Regulations (TSCA): Exempt as a pharmaceutical substance
Canada (DSL/NDSL): Exempt; regulated by the Food and Drugs Act
EU Regulations (REACH): Considered a medicinal product; exempt from registration under Article 2(5)
OSHA HazCom: Considered hazardous chemical for workplace labeling
Additional National Regulations: Subject to prescription control, scheduled drug controls in various jurisdictions
Labeling Requirements: Pharmaceutical labeling standards apply, with additional chemical hazard labeling in laboratory or industrial use
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