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MSDS for Edoxaban Impurity F (Monomer)

1. Identification

Product Name: Edoxaban Impurity F (Monomer)
Chemical Name: 1-(4-Chlorophenyl)-3-(5-methyl-4-phenyl-[1,2,4]oxadiazol-3-yl)urea
SYNONYMS: Edoxaban Related Compound F, N/A
Company Identification: Manufacturer’s details or qualifier, emergency phone contact
Recommended Use: Analytical and research applications only, not intended for diagnostic or therapeutic use
CAS Number: [Request accurate CAS or use internal identifier]
UN Number: Not classified under UN transport regulations
REACH Registration: Exempt or not registered

2. Hazard Identification

Classification: Substance is not classified as hazardous according to GHS/CLP criteria based on available data
Label Elements: No hazard pictograms, no signal words required
Hazard Statements: Not considered hazardous if handled correctly
Other Hazards: Dust may irritate respiratory system or eyes; avoid excessive inhalation or contact with skin
Routes of Exposure: Ingestion, inhalation, dermal, ocular contact
Precautionary Statements: Wear gloves, safety glasses; practice good hygiene
Target Organs: Data not available; handle as potentially toxic

3. Composition / Information on Ingredients

Chemical Name: Edoxaban Impurity F (Monomer)
Formula: C16H11ClN4O2
Molecular Weight: 326.74 g/mol
Concentration: 100% (pure substance for reference laboratories)

4. First Aid Measures

Inhalation: Move person to fresh air, keep at rest; seek medical advice if symptoms persist
Skin Contact: Wash with soap and plenty of water, remove contaminated clothing
Eye Contact: Rinse with water for several minutes, seek medical attention for persistent irritation
Ingestion: Rinse mouth, never induce vomiting; get medical help if symptoms develop
Symptoms to Expect: Irritation, dizziness, headache possible if exposed in large amounts
Note to Physician: Treat symptomatically, no known antidote

5. Fire-Fighting Measures

Suitable Extinguishing Media: Use dry powder, carbon dioxide, or foam; avoid direct water jets on burning powder
Hazards During Fire: Combustion may produce toxic gases: hydrogen chloride, nitrogen oxides, carbon oxides
Protective Equipment: Firefighters need self-contained breathing apparatus and protective clothing
Further Advice: Prevent contaminated runoff; cool containers with water not in direct path of flames

6. Accidental Release Measures

Personal Precautions: Proper gloves, safety goggles, dust mask recommended
Environmental Precautions: Do not allow to reach drains, waterways, soil
Containment: Collect powder mechanically, sweep up avoiding dust formation
Cleaning Methods: Transfer material to closed container; wash area thoroughly
Disposal: Dispose according to local, regional, national laws; avoid discharge to environment

7. Handling and Storage

Safe Handling: Use in ventilated area, minimize dust, avoid breathing fine particles
Hygiene: Wash hands after handling, change out of contaminated clothing
Storage Conditions: Store in cool, dry place; container tightly closed, away from incompatible substances like strong oxidizers
Incompatibility: Avoid contact with acids, alkalis, oxidizing materials
Special Precautions: Keep away from food, beverages, and animal feed

8. Exposure Controls and Personal Protection

Exposure Limits: No workplace exposure limits established; minimize exposure
Engineering Controls: Local exhaust ventilation or work in fume hood
Personal Protective Equipment: Gloves (nitrile recommended), lab coat, safety glasses, dust-filtering respirator for powder handling
Environmental Controls: Prevent spillage to drains or ground

9. Physical and Chemical Properties

Physical State: Solid, powder or crystalline
Color: Data varies; typically white to off-white
Odor: Odorless or faint chemical odor
Melting Point: Estimated range 190–250°C (experimental values recommended)
Boiling Point: Decomposes before boiling
Solubility: Poorly soluble in water, soluble in polar organic solvents (DMSO, methanol)
pH: Not applicable for solid
Vapor Pressure: No data available
Density: Data not specified for monomer
Other Data: Non-volatile, not flammable in raw state

10. Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Hazardous Reactions: No hazardous polymerization or violent reactions expected
Decomposition: On heating, risk of toxic fumes
Incompatible Materials: Strong oxidizers, acids, bases
Conditions to Avoid: High heat, direct sunlight, moisture exposure

11. Toxicological Information

Likely Routes of Exposure: Inhalation, skin and eye contact, ingestion
Acute Toxicity: No data for acute oral, dermal, or inhalation toxicity; take precautions
Skin Irritation: Prolonged contact may cause mild irritation
Eye Irritation: Dusts may cause eye irritation
Chronic Toxicity: No long-term toxicity studies available
Carcinogenicity/Mutagenicity: Not listed by IARC, NTP, or OSHA as carcinogen
Sensitization: No reports of sensitization
Other Health Data: Handle with care; similar compounds sometimes affect blood or liver at high levels

12. Ecological Information

Ecotoxicity: No specific data for Edoxaban Impurity F; structurally related substances may show aquatic toxicity at certain thresholds
Mobility: Low water solubility reduces mobility in environment
Persistence and Degradability: Likely not rapidly biodegradable
Bioaccumulative Potential: Data not available; handle as persistent organic pollutant
Other Risks: Prevent contamination of surface waters, soils, and drains

13. Disposal Considerations

Waste Disposal: Treat waste as hazardous chemical; contact licensed waste disposal professionals
Container Disposal: Empty containers should be triple rinsed and disposed of with care
Disposal Methods: Incineration recommended, follow local, state, and federal regulations

14. Transport Information

UN Number: Not classified as a dangerous good under transport regulations
Transport Hazard Class: Not regulated
Packing Group: Not assigned
Labels Required: None
Special Precautions: Avoid extreme temperatures, movement should prevent breakage or spillage

15. Regulatory Information

EU Regulations: Not listed in Annex II of REACH; not classified as dangerous; ensure compliance with workplace safety directives
US Regulations: Not subject to SARA sections 302, 313; not listed on TSCA
International Inventories: Not listed on major chemical inventories such as AICS, DSL, EINECS
Other Requirements: Adhere to occupational safety laws and international chemical storage norms