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Product Name: Azilsartan
Chemical Name: 2-ethoxy-1-([2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl)-1H-benzimidazole-7-carboxylic acid
Synonyms: Azilsartan medoxomil, TAK-491
CAS Number: 147403-03-0
Recommended Use: Pharmaceutical active ingredient
Manufacturer/Supplier: Provided upon request
Emergency Contact: Provided upon request
Classification: Not classified as hazardous under GHS for supplied pharmaceutical form
Signal Word: None required for finished drug product
Hazard Statements: May cause eye irritation; potential for sensitization through skin contact; harmful if ingested in large quantities
Routes of Exposure: Inhalation, skin, eye, ingestion
Target Organs: Kidneys, liver (based on animal studies)
Active Ingredient: Azilsartan (CAS: 147403-03-0), typically 98-100% pure in bulk API
Impurities: Traces of synthesis byproducts; proprietary levels maintained below regulated thresholds
Inactive Ingredients: None in pure API form
Inhalation: Move affected person outdoors. Monitor for respiratory distress. Give oxygen if breathing becomes difficult. Seek medical attention.
Skin Contact: Remove contaminated clothing. Wash skin thoroughly with soap and water. Get medical advice if irritation or symptoms develop.
Eye Contact: Rinse with plenty of gently flowing water for at least 15 minutes, keeping eyelids open. Remove contact lenses if present. Obtain medical help.
Ingestion: Rinse mouth. Give water to drink if conscious and alert. Do not induce vomiting unless recommended by medical personnel. Get immediate medical attention.
Suitable Extinguishing Media: Water spray, dry chemical, foam, or carbon dioxide
Unsuitable Media: Direct stream of water (may scatter powder)
Special Hazards: Emits toxic fumes of carbon oxides, nitrogen oxides, and possibly halogenated compounds upon combustion
Protective Equipment: Firefighters wear self-contained breathing apparatus and chemical-protective clothing
Additional Advice: Move containers from fire area if you can do so safely. Avoid inhaling smoke, vapors, or gases.
Personal Precautions: Avoid dust formation. Use personal protective equipment as specified. Evacuate area if material in bulk
Environmental Precautions: Prevent run-off to sewers, surface, or ground water. Report significant spills to local authorities
Clean-Up Methods: Use damp absorbent material (inert substance) to collect. Place into a dry, labeled container for disposal. Wipe residue with wet cloth or mop. Ventilate area after cleanup.
Handling: Avoid generating dust. Use with adequate ventilation. Minimize exposure through use of containment and proper PPE.
Hygiene Measures: Wash hands thoroughly after use. Do not eat, drink, or smoke in handling area. Handle API in accordance with good industrial hygiene practices.
Storage: Store in original, tightly closed container in a cool, dry, well-ventilated area. Protect from light, heat, and moisture. Keep away from incompatible substances (strong oxidizers, acids, bases).
Recommended Engineering Controls: Enclosed systems, local exhaust ventilation, or process isolation, especially during weighing and transfer
Exposure Limits: No occupational exposure limits established for Azilsartan
Personal Protective Equipment: NIOSH-approved dust respirator, nitrile gloves, chemical safety goggles, and laboratory coat or coveralls
Environmental Protection: Use closed systems or engineering containment to reduce environmental exposure during large scale operations.
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not available
pH: Slightly acidic (Aqueous suspension)
Melting Point: Approximately 255-260°C
Boiling Point: Decomposes before boiling
Flash Point: Not applicable
Evaporation Rate: Not applicable
Flammability: Not highly flammable
Vapor Pressure: Negligible at ambient conditions
Relative Density: 1.5–1.7 g/cm³ (approximate)
Solubility: Practically insoluble in water; soluble in DMSO, methanol
Partition coefficient (log P): ~3.2
Auto-Ignition Temperature: No data available
Decomposition Temperature: >240°C
Chemical Stability: Stable under recommended storage conditions and normal temperatures
Possible Hazardous Reactions: No hazardous polymerization expected
Conditions to Avoid: Prolonged exposure to light, moisture, and elevated temperatures
Incompatible Materials: Strong oxidizers, acids, bases
Hazardous Decomposition Products: Toxic gases (CO, CO₂, NOx, possibly halogenated compounds)
Acute Toxicity: Low acute toxicity in animal models; oral LD₅₀ (rat) > 3000 mg/kg
Skin Irritation: Mild; not a significant skin irritant in rabbits
Eye Irritation: Possible mild irritation
Sensitization: Not a known sensitizer, but repeated contact may increase risk
Chronic Effects: Animal studies show effects on kidneys and liver after high, repeated dosing
Genotoxicity: Negative in bacterial mutation assay and in vivo micronucleus test
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, or OSHA
Reproductive & Developmental Toxicity: High doses produced adverse developmental effects in animals
Ecotoxicity: Data limited; expected to be low based on low solubility and bioaccumulation
Persistence and Degradability: Not readily biodegradable; may persist in environment
Bioaccumulative Potential: Not expected to bioaccumulate significantly
Mobility in Soil: Low mobility due to low water solubility
Other Adverse Effects: Limited detailed information; handle to prevent uncontrolled environmental release
Waste Treatment Methods: Incinerate in accordance with local and national regulations; avoid landfilling pure material
Container Disposal: Triple rinse empty containers; offer for recycling or proper disposal
Additional Advice: Do not discharge to drains, surface water, or soil; consult authorized waste disposal contractor
UN Number: Not regulated for transport by road, rail, sea, or air
Proper Shipping Name: Not classified as a dangerous good
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Marine Pollutant: No
Special Precautions: Protect packaging against physical damage, moisture, and excessive heat during shipment
US TSCA: Exempt as a pharmaceutical product
EU REACH: Exemption applies to active pharmaceutical ingredients
OSHA Status: Not specifically regulated
WHMIS (Canada): Not controlled
EPA SARA Title III: Not listed as a hazardous substance
Labeling Requirements: Pharmaceutical use only; not for general consumer use; keep out of reach of children
