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Material Safety Data Sheet (MSDS) for Olmesartan Medoxomil

Identification

Product Name: Olmesartan Medoxomil
Chemical Name: 2,3-dihydroxy-2-butenedioic acid mono-[4-(1-hydroxy-1-methylethyl)-2-propyl-1H-imidazol-5-yl] methyl ester
CAS Number: 144689-63-4
Synonyms: Olmetec, CS-866
Manufacturer: [Insert appropriate manufacturer]
Recommended Use: Antihypertensive agent
Supplier Contact Information: [Manufacturer address and phone number]
Emergency Phone Number: [Emergency number]

Hazard Identification

GHS Classification: Not classified as dangerous according to OSHA Hazard Communication Standard
Signal Word: None
Hazard Statements: May cause eye irritation, may cause skin irritation, may cause respiratory tract irritation
Precautionary Statements: Avoid contact with eyes, skin, clothing; avoid breathing dust; wash thoroughly after handling
Potential Health Effects: Eye redness, mild skin reactions, coughing or irritation from dust inhalation
Environmental Hazards: May be harmful to aquatic organisms

Composition / Information on Ingredients

Chemical Name: Olmesartan Medoxomil
Concentration: >98%
CAS Number: 144689-63-4
Impurities/Additives: None significant
Formula: C29H30N6O6
Molecular Weight: 558.59 g/mol

First Aid Measures

Eye Contact: Rinse immediately with plenty of water for at least 15 minutes. Remove contact lenses if present. Seek medical attention for persistent irritation.
Skin Contact: Remove contaminated clothing. Wash affected area with soap and water. Get medical assistance if symptoms occur.
Inhalation: Move to fresh air. Provide artificial respiration if breathing stops. Contact a physician if symptoms like coughing or difficulty breathing continue.
Ingestion: Rinse mouth with water if conscious. Do not induce vomiting unless directed by medical personnel. Obtain medical help immediately.
Most Important Symptoms: Eye or skin irritation, coughing, gastrointestinal discomfort
Protection for First Responders: Use appropriate personal protective equipment such as gloves, goggles, and dust mask.

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, foam
Specific Hazards: Combustion produces carbon monoxide, carbon dioxide, nitrogen oxides, and toxic fumes
Special Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective gear
Explosion Data: Not sensitive to mechanical impacts or static charge
Hazardous Combustion Products: Gases mentioned above can pose inhalation risk

Accidental Release Measures

Personal Precautions: Wear gloves, protective clothing, goggles, and appropriate respirator; avoid dust formation and inhalation
Measures for Environmental Protection: Prevent material from entering sewers, waterways, or soil
Cleanup Methods: Sweep up material without creating dust, place in appropriate closed container for disposal, wash spill site with soap and water after collection
Reference to Other Sections: Wear personal protective equipment as described in Section 8

Handling and Storage

Precautions for Safe Handling: Avoid skin and eye contact, avoid inhalation of dust, handle only in well-ventilated areas, do not eat, drink, or smoke when using
Conditions for Safe Storage: Store in tightly closed container, keep in cool, dry and well-ventilated location, protect from moisture, light, and incompatible substances like strong oxidizers
Incompatible Materials: Strong oxidizing agents
Specific End Use: Intended for laboratory, pharmaceutical, or research use

Exposure Controls and Personal Protection

Engineering Controls: Use local exhaust ventilation; keep airborne levels below occupational exposure limits
Personal Protective Equipment: Protective gloves, lab coat, safety goggles, dust mask or approved respirator
Hygiene Measures: Always wash hands after handling; remove and wash contaminated clothing
Occupational Exposure Limit Values: No OSHA PEL or ACGIH TLV established for Olmesartan Medoxomil

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not determined
pH: No data available
Melting Point: 180-186°C
Boiling Point: Decomposes before boiling
Flash Point: Not flammable
Evaporation Rate: Not applicable
Flammability: Not flammable
Vapor Pressure: Negligible at room temperature
Vapor Density: Not applicable
Relative Density: About 1.3 g/cm³
Solubility: Slightly soluble in water, soluble in methanol and DMSO
Partition Coefficient (log Kow): 0.55 (estimated)
Auto-ignition Temperature: No data available
Decomposition Temperature: Above 186°C
Viscosity: Not applicable

Stability and Reactivity

Chemical Stability: Stable under normal handling and storage conditions
Reactivity: No dangerous reactions known under recommended conditions
Possibility of Hazardous Reactions: No polymerization expected
Conditions to Avoid: Moisture, extreme heat, direct sunlight
Incompatible Materials: Strong oxidizers
Hazardous Decomposition Products: Carbon oxides, nitrogen oxides, and potential irritant gases

Toxicological Information

Routes of Exposure: Eye, skin, inhalation, ingestion
Acute Toxicity: Oral LD50 (rat): >1000 mg/kg
Chronic Toxicity: No evidence of carcinogenicity in animal studies
Skin Corrosion/Irritation: May cause mild irritation
Serious Eye Damage/Irritation: May cause temporary discomfort
Respiratory or Skin Sensitization: Not expected to be a sensitizer
Mutagenicity: No mutagenic effects observed in regulatory tests
Reproductive Toxicity: No teratogenic effects at therapeutic doses
Other Relevant Toxicity: May cause gastrointestinal symptoms, dizziness at higher exposure

Ecological Information

Ecotoxicity: May impact aquatic organisms at high concentrations.
Persistence and Degradability: Not readily biodegradable, persistent in the environment
Bioaccumulative Potential: Low potential for bioaccumulation
Mobility in Soil: Limited mobility due to low water solubility
Other Adverse Effects: No specific data on environmental risks, pharmaceutical agents in general can impact aquatic life

Disposal Considerations

Waste Treatment Methods: Dispose of product and container via licensed waste disposal company.
Unused/Uncontaminated Material: Treat as hazardous pharmaceutical waste.
Contaminated Packaging: Dispose in accordance with local, regional, and national regulations.
Sewage Disposal: Do not discharge into drains, water courses, or onto the ground.
Special Precautions: Wear appropriate personal protective equipment during disposal operations.

Transport Information

UN Number: Not regulated as hazardous for transport
UN Proper Shipping Name: Not classified for transport
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Marine Pollutant: Not listed
Special Precautions for Users: Prevent package breakage, avoid rough handling
Transport in Bulk: Not regulated under MARPOL Annex II or IBC Code

Regulatory Information

US Federal Regulations: Not classified as a hazardous chemical under OSHA; not listed on SARA Title III Sections 302/304/313
TSCA Status: Not listed
EU Regulations: Not classified as a hazardous substance under Regulation (EC) No 1272/2008
Canada (DSL/NDSL): Not listed
State Regulations: Check applicable state-specific regulations
Other International Regulations: Complies with REACH; not subject to further international restrictions