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Product Name: Ezetimibe Intermediate 1
Chemical Name: (R)-1-(4-fluorophenyl)-3-(3-(4-fluorophenyl)-2-oxiranyl)propan-1-one
SYNONYMS: Ezetimibe Key Intermediate 1
CAS Number: Provided by the supplier upon request
Manufacturer: Contact details provided on request from purchasing documentation
Recommended Use: Pharmaceutical intermediate
Restrictions on Use: Not for personal, food, or household application
Hazard Classification: Irritant to eyes and respiratory tract
Signal Word: Warning
Hazard Statements: May cause skin and eye irritation, may cause respiratory irritation
Pictograms: Exclamation mark
Precautionary Statements: Avoid breathing dust, prevent contact with eyes and skin, use only outdoors or in well-ventilated areas
Chemical Composition: Contains (R)-1-(4-fluorophenyl)-3-(3-(4-fluorophenyl)-2-oxiranyl)propan-1-one
Purity: >98% by HPLC analysis
Impurities: Trace process impurities (<2%), proprietary to manufacturing
Stabilizing Additives: None indicated
Exposure Limits: No occupational exposure limits established for this compound
Eyes: Rinse cautiously with water for several minutes; remove any contact lenses if present; continue rinsing
Skin: Wash with plenty of soap and water; remove contaminated clothing; seek medical attention for persistent irritation
Inhalation: Remove to fresh air; keep at rest; seek medical attention for symptoms
Ingestion: Rinse mouth thoroughly; do not induce vomiting; get prompt medical advice
Most Important Symptoms: Eye redness, burning sensation, cough, skin irritation
Suitable Extinguishing Media: Dry chemical, carbon dioxide, foam, water spray (avoid high-pressure streams)
Specific Hazards: May emit noxious fumes including hydrogen fluoride, carbon oxides, when heated
Advice for Firefighters: Wear full protective gear, self-contained breathing apparatus recommended
Special procedures: Avoid breathing decomposition substances, fight fire from safe distance, keep runoff out of sewers and waterways
Explosion Hazard: Dust may pose explosion risk under specific conditions
Personal Precautions: Wear appropriate respiratory and skin protection, ventilate area
Environmental Precautions: Prevent from entering drains, surface and groundwater
Cleanup Methods: Absorb spill with inert material, sweep up and place in suitable, labeled containers for disposal
Decontamination: Clean contaminated surfaces thoroughly with water and detergent
Reference to Other Sections: See Exposure Controls and Disposal Considerations
Handling: Keep container tightly closed, handle in well-ventilated areas, avoid generating dust, minimize exposure through skin contact
Storage Conditions: Store at 2–8°C, away from strong oxidizers, acids, bases
Incompatible Materials: Strong acids, alkalis, oxidizing agents
Transfer Precautions: Ground and bond containers to avoid static discharge
Safety Engineering: Use local exhaust ventilation when working with powders, follow standard pharmaceutical handling procedures
Engineering Controls: Use local ventilation, safety shower, and eyewash station accessible in work area
Respiratory Protection: Approved dust respirator if exposure risk exists
Eye Protection: Chemical safety goggles
Skin Protection: Chemical-resistant gloves, lab coat, and closed-toed shoes recommended
Hygiene Measures: Wash hands before breaks and after handling; change contaminated clothing immediately
Appearance: White to pale yellow crystalline powder
Odor: No characteristic odor
pH: Not applicable (not water soluble)
Melting Point: 138–142°C
Boiling Point: Data not available
Flash Point: >160°C
Flammability: Dust form may ignite under certain conditions
Solubility: Insoluble in water; soluble in most organic solvents
Vapor Pressure: Low at room temperature
Partition Coefficient (log Kow): Data not determined
Stability: Stable under recommended storage conditions, sensitive to strong ultraviolet light
Reactivity: No dangerous reactions known under normal handling
Hazardous Decomposition: Hydrogen fluoride, carbon monoxide, carbon dioxide under fire
Incompatible Conditions: Exposure to strong acids, alkalis, oxidizing materials
Polymerization: Not expected under normal use
Acute Toxicity: No data on acute human toxicity; use with caution
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Symptoms: Irritation of mucous membranes, skin, eyes; respiratory discomfort
Chronic Effects: Prolonged exposure may lead to sensitization or dermatitis
Carcinogenicity: No evidence based on available data for this intermediate
Mutagenicity: No genotoxic data available; standard precautions advised
LD50/LC50: Not established for this compound
Ecotoxicity: No specific data available; avoid release into environment
Persistence and Degradability: Prediction models indicate slow breakdown in soil and water
Bioaccumulation: Potential is low due to limited solubility
Mobility In Soil: Expected to be immobile due to low water solubility
Other Adverse Effects: Eco-toxicity not fully evaluated; prudent disposal required
Disposal Methods: Dispose through licensed hazardous waste contractor, incineration recommended
Contaminated Packaging: Triple rinse and forward to chemical waste stream
Waste Codes: Consult with local authorities for applicable classification
Special Precautions: Do not discharge to environment, avoid landfill or sewage system
Disposal Guidance: Follow all local, regional, and national regulations
UN Number: Not classified for transport
UN Proper Shipping Name: Not regulated
Transport Hazard Class: Not assigned
Packing Group: Not applicable
Special Transport Precautions: Protect from physical damage and direct sunlight
Bulk Transport: Follow pharmaceutical industry good practice
Regulatory Status: Not listed specifically by OSHA, NIOSH, ACGIH, or EPA
Labeling Requirements: Meets workplace hazardous material labeling rules (OSHA HCS)
SARA Title III: Not listed as a toxic or hazardous substance
TSCA Inventory: Research and development use only; not listed
REACH Status: Manufacturer must provide guidance; not subject to registration at this stage
Other Regulations: Local regulations may apply; handle in accordance with country-specific chemical safety programs
