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Product Name: Apremilast
Chemical Name: N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl]acetamide
CAS Number: 608141-41-9
Recommended Use: Pharmaceutical ingredient
Supplier Details: Manufacturer’s name, Address, Telephone, Emergency contact
GHS Classification: Not classified as hazardous
Physical Hazards: None identified for bulk solid; avoid inhalation/dust
Health Hazards: Possible mild eye or skin irritant; ingestion may affect gastrointestinal system
Environmental Hazards: Limited information on environmental impact; minimize release to water or soil
Signal Word: Not applicable
Hazard Statements: Not applicable
Precautionary Statements: Use in well-ventilated area, avoid ingestion or inhalation of powder
Chemical Identity: Apremilast
Purity: Greater than 98%
Synonyms: CC-10004
Impurities: Manufacturing-related trace impurities generally below regulatory limits
Additives: None
Mixture: Substance is used as a pure active ingredient in medical formulations
Inhalation: Move to fresh air, monitor for breathing difficulty, seek medical attention if symptoms persist
Skin Contact: Wash with soap and water, remove contaminated clothing, seek care if irritation develops
Eye Contact: Rinse gently with water for at least 15 minutes, avoid rubbing, obtain medical attention if irritation remains
Ingestion: Rinse mouth with water, do not induce vomiting, get medical advice promptly
Important Symptoms: Nausea, headache, minor allergic reaction in hypersensitive individuals
Suitable Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or foam
Specific Hazards: May emit nitrogen oxides, carbon oxides, sulfur oxides when burning
Protective Equipment: Wear self-contained breathing apparatus and full protective gear
Firefighting Instructions: Cool containers with water, prevent runoff from entering drains
Hazardous Combustion Products: Toxic fumes possible under fire conditions
Personal Precautions: Avoid inhaling dust, ventilate area, wear appropriate protective equipment
Spill Cleaning Method: Pick up bulk material with minimal dust generation, place in closed containers for disposal
Environmental Precautions: Keep out of sewage, drains, and waterways
Decontamination: Wash area with water and detergent, absorb rinsate with suitable material
Handling: Use local exhaust or enclosure for dust, avoid contact with skin, eyes, and clothing
Storage: Store in closed, labeled containers at room temperature, keep away from incompatible substances
Storage Conditions: Dry, cool, well-ventilated space
Safe Handling Advice: Keep away from food, drink, and animal feed, avoid generating dust or aerosols
Exposure Limits: No occupational exposure limit established; minimize dust generation
Engineering Controls: Work in a chemical fume hood or ventilated area
Personal Protective Equipment: Use impervious gloves, safety glasses, lab coat; use respiratory protection for dust
Hygiene Practices: Wash hands before eating or drinking, keep contaminated clothing separate
Appearance: White or off-white powder
Odor: Odorless
pH: Not applicable
Melting Point: 156-158 °C
Boiling Point: Decomposition above 250 °C
Flash Point: Data not available
Solubility: Slightly soluble in water; soluble in organic solvents (e.g., DMSO, methanol)
Density: About 1.4 g/cm³
Other Properties: Stable under normal conditions
Stability: Chemically stable at room temperature
Reactivity: No unusual reactivity expected
Conditions to Avoid: Moisture, extreme temperatures
Incompatible Materials: Strong oxidizers, acids, bases
Hazardous Decomposition Products: May generate CO, CO₂, SOx, and nitrogen compounds under combustion
Acute Toxicity: Low acute toxicity by oral or dermal exposure based on available data
Inhalation: May cause mild respiratory tract irritation from dust
Skin Contact: Mild irritation may occur on sensitive individuals
Eye Contact: Possible mild discomfort
Chronic Effects: Clinical studies in pills show limited adverse effects, gastrointestinal upset at high doses
Carcinogenicity: No evidence of carcinogenicity in animal studies
Mutagenicity: Not found to be mutagenic based on preclinical tests
Sensitization: Rarely could cause allergic reaction on repeated exposure
Ecotoxicity: No significant adverse effects shown in aquatic testing at low, realistic concentrations
Persistence and Degradability: Moderate persistence in the environment, partial biodegradability
Bioaccumulative Potential: Not likely to bioaccumulate significantly in aquatic species or terrestrial food chains
Mobility: Low mobility in soil expected based on physical chemical data
Other Effects: Pharmaceutical residues can pose risk if released in bulk; dispose as hazardous waste
Disposal Methods: Dispose in accordance with local, regional, national, and international regulations
Waste Classification: Hazardous waste if in bulk; avoid discharge to environment
Container Disposal: Empty containers must be handled with care and disposed properly; do not reuse
Recycling Information: Not recyclable, incinerate under controlled conditions
Recommended Practices: Use licensed hazardous waste contractor for large quantities
UN Number: Not regulated for transport
UN Proper Shipping Name: Not assigned
Transport Hazard Class: Not classified as dangerous goods
Packing Group: Not applicable
Special Precautions: Prevent accidental leakage or spillage during transport
Transport in Bulk: Not applicable
Environmental Hazards: Not a marine pollutant per current classification
EU Regulations: Not classified as hazardous under CLP Regulation (EC) No. 1272/2008
US Regulations: Not listed on US TSCA; regulated as a pharmaceutical compound
Global Inventory: Not present on most chemical inventories; regulated via drug licensing authorities
Other Regulations: Use and handling subject to jurisdictional pharmaceutical regulations and worker protection standards
