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Product Name: Candesartan
Chemical Name: 2-Ethoxy-1-([2′-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl)-1H-benzimidazole-7-carboxylic acid
Synonyms: Candesartan cilexetil (its prodrug), Atacand (trade name)
CAS Number: 139481-59-7
Recommended Use: Pharmaceutical ingredient, antihypertensive
Supplier Information: Manufacturer or distributor details listed on shipment documents
Classification: Not classified as hazardous under GHS for workplace exposure
Hazard Statements: May cause mild irritation to eyes, respiratory system, or skin after repeated or prolonged contact
Signal Word: None required under GHS
Precautionary Statements: Avoid unnecessary contact; avoid inhalation of dust; wash hands after handling
Emergency Overview: Solid white or off-white powder, minimal odor, not considered highly hazardous, but care advised in pharmaceutical environments
Potential Health Effects: Dust may cause mild discomfort in the respiratory system or on skin; pharmaceutical effects include blood pressure reduction on significant exposure
Candesartan: ≥97% by weight
Inactive Ingredients: None reported for active pharmaceutical ingredient grade
Impurities: Trace organic compounds & process-related residuals, all below regulated thresholds
Formulation Excipients (if finished product): See manufacturer documentation for tablets or suspensions
Inhalation: Remove the person to fresh air; provide artificial respiration if breathing stops; seek medical attention for persistent symptoms
Skin Contact: Immediately wash with soap and plenty of water; remove any contaminated clothing; medical attention for redness or irritation that continues
Eye Contact: Rinse thoroughly with lukewarm water for at least 15 minutes, keeping eyelids open; do not rub eyes; consult a physician if irritation continues
Ingestion: Rinse mouth thoroughly with water; do not induce vomiting unless directed by a medical professional; seek prompt medical attention for large quantities or persistent symptoms
Most Important Symptoms: May cause mild gastrointestinal disturbances or mild respiratory tract discomfort; sensitive individuals should get medical evaluation
Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical powder, or appropriate foam for primary cause of fire
Specific Hazards: Product is not highly flammable; thermal decomposition may release hazardous fumes such as nitrogen oxides and carbon oxides
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and protective clothing if involved in a fire
Special Procedures: Avoid inhaling potential combustion byproducts; isolate area and cool containers exposed to flames
Personal Precautions: Use protective gloves and goggles; avoid breathing dust; evacuate unnecessary personnel
Environmental Precautions: Prevent large spills from entering drains or watercourses; minimize dust generation
Methods for Clean-Up: Collect powder using damp cloth or HEPA-filtered vacuum; dispose as pharmaceutical waste in accordance with regulations; ventilate area and wash surfaces after removal
Handling: Use with local exhaust ventilation; handle in accordance with good industrial hygiene; avoid formation and inhalation of dust
Storage: Store in tightly closed container in a cool, dry, well-ventilated location; keep away from incompatible materials (strong oxidizers)
Incompatibilities: Avoid contact with high-temperature surfaces, oxidizing agents, and moisture
Safe Transfer Procedures: Use tools and minimize handling to reduce risk of accidental release
Occupational Exposure Limits: No specific limits for candesartan; use pharmaceutical exposure control practices
Engineering Controls: Local exhaust ventilation or fume hood recommended in bulk handling areas
Eye Protection: Chemical safety goggles or safety glasses
Skin Protection: Laboratory coat, gloves (nitrile or latex), and closed-toe shoes
Respiratory Protection: Dust mask or particle respirator in cases of dust generation
Hygiene Measures: Wash hands thoroughly after handling, before eating or drinking
Appearance: White or almost white crystalline powder
Odor: Nearly odorless
pH: Not applicable in solid form; slightly acidic in solution
Melting Point: 168°–170°C
Boiling Point: Data not available; decomposes before boiling
Flash Point: Data not available, not highly flammable
Solubility: Practically insoluble in water, soluble in organic solvents such as methanol and DMSO
Vapor Pressure: Not volatile
Density: Approximately 1.15 g/cm³
Partition Coefficient (log Pow): Estimated ~4.5, suggesting moderate lipophilicity
Stability: Stable under ordinary conditions of use and storage
Other Data: Bulk density varies by manufacturing process
Chemical Stability: Stable under normal conditions, both physically and chemically
Reactivity: No dangerous reactions expected during normal handling
Hazardous Reactions: Avoid contact with strong oxidizing agents that could accelerate degradation or combustion
Decomposition Products: Yields carbon oxides and nitrogen oxides if subjected to fire or excessive heating
Conditions to Avoid: Exposure to strong acids/bases, direct sunlight, and moisture
Routes of Exposure: Inhalation, skin and eye contact, accidental ingestion
Acute Toxicity Data: LD50 (oral, mouse): >2000 mg/kg; low acute toxicity in animal studies
Irritation: Mild skin and mucous membrane irritant in some individuals
Sensitization: Not a known sensitizer based on current animal and human data
Mutagenicity/Carcinogenicity: Not classified as mutagenic or carcinogenic according to current regulatory reviews
Pharmacological Effects: Potent angiotensin II receptor antagonist; may lower blood pressure if absorbed systemically
Long-Term Exposure: No significant adverse effects identified at environmental or occupational exposure levels
Ecotoxicity: No evidence of acute environmental hazard; may be harmful to aquatic life in large concentrations
Persistence and Degradability: Degrades slowly; not considered readily biodegradable
Bioaccumulation: Moderate potential due to lipophilicity, but does not biomagnify significantly in the food web
Mobility in Soil: Binds moderately to soil particles, low mobility under ordinary environmental conditions
Other Adverse Effects: No known significant impact on sewage treatment processes at predicted concentrations
Waste Disposal Methods: Dispose of unused material as pharmaceutical waste following local or national regulations; do not discharge into natural waterways
Container Disposal: Rinse empty containers with solvent, then dispose according to pharmaceutical waste protocols
Special Precautions: Use authorized waste disposal contractors; document pharmaceutical waste streams per regulatory requirements
UN Number: Not regulated
Proper Shipping Name: Not applicable; not classified as a hazardous material for transport
Hazard Class: None specified
Packing Group: Not regulated
Special Precautions for Transport: Protect containers from physical damage and moisture; keep sealed and labeled during transit
Regulatory Status: Listed as a prescription pharmaceutical ingredient; not classified under major transport hazard regulations
Labeling Requirements: Compliance with national and international labeling and handling directives for pharmaceuticals
Inventory Status: Registered under relevant inventories for pharmaceutical substances (e.g., EU REACH exemption for medicinal products)
Other Requirements: Observe workplace exposure controls in pharmaceutical manufacturing; maintain access to MSDS at site
