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Product Name: Entacapone
Chemical Name: (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide
Molecular Formula: C14H15N3O5
Molecular Weight: 305.29 g/mol
Synonyms: Comtan, OR-611
Manufacturer: Pharmaceutical companies producing APIs
Intended Use: Parkinson’s disease management as a COMT inhibitor
CAS Number: 130929-57-6
Emergency Contact: Refer to company’s emergency response contacts
GHS Classification: Not classified as hazardous under GHS criteria
Health Hazards: May cause respiratory irritation, eye or skin irritation on contact, risk of allergic reactions, may be harmful if swallowed
Environmental Hazards: Potential local aquatic toxicity
Physical Hazards: Combustible as fine powder, dust may form explosive mixtures with air
Pictograms: No mandatory pictograms for general exposure, but precautionary caution advised
Signal Word: None mandated
Precautionary Statements: Avoid inhalation, skin and eye contact, avoid release to the environment
Main Ingredient: Entacapone (purity ≥98%)
Chemical Formula: C14H15N3O5
Impurities: Process and related impurities <2%
Stabilisers: None typically present
Excipient Content: None in API form
Inhalation: Move to fresh air, support breathing as needed, seek medical attention for symptoms
Skin Exposure: Wash with soap and water, remove contaminated clothing, medical advice if irritation persists
Eye Contact: Rinse with running water for several minutes, continue if irritation occurs, consult physician
Ingestion: Rinse mouth, do not induce vomiting, seek immediate medical attention
Acute Symptoms: Irritation, nausea, labored breathing, potential allergic response
Specific Treatment Required: None documented, treat symptomatically
Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, foam
Unsuitable Extinguishing Methods: Direct water jet on powder
Specific Hazards: May form hazardous fumes (carbon oxides, nitrogen oxides) if combusted
Protective Equipment for Firefighters: Self-contained breathing apparatus, full protective gear
Fire/Explosion Risks: Fine dust particles can pose explosion risk in closed spaces
Special Firefighting Procedures: Avoid inhalation of combustion products, ventilate area
Protective Measures: Wear gloves, goggles, laboratory coat, mask or respirator
Environmental Precautions: Prevent entry into drains, sewage, or natural waterways
Cleanup Methods: Scoop or vacuum up spilled material with HEPA vacuum, avoid dust generation, dispose according to regulations
Spill Response: Isolate area, ventilate, minimize spreading, wash spill area after cleanup
Safe Handling: Prevent dust buildup, avoid generating aerosols, use fume hood or local exhaust, minimize direct contact
Handling Precautions: Use only in well-ventilated spaces, avoid ingesting, use barrier creams if skin-sensitization risk identified
Storage Conditions: Store in tightly closed container, cool dry place away from sunlight, keep away from incompatible substances like strong oxidizers
Storage Temperature: Recommended below 25°C, avoid freezing or excessive heat
Packing Materials: Use break-resistant, sealing containers
Exposure Limits: No official occupational exposure limits established
Engineering Controls: Chemical fume hood, adequate general ventilation, local exhaust
Personal Protective Equipment: Gloves (nitrile or latex), safety goggles or face shield, lab coat or gown, respiratory protection where dust is formed
Hygiene Measures: Wash hands thoroughly after handling, remove contaminated clothing
Appearance: Yellowish-brown to orange crystalline powder
Odor: Odorless
Melting Point: 150 – 152°C
Boiling Point: Not available/decomposes
Solubility: Slightly soluble in water, soluble in methanol and ethanol
pH (solution): Not applicable
Partition Coefficient (log Pow): Approximately 2.5
Vapor Pressure: Not measurable at room temperature
Density: Approx. 1.4 g/cm³
Flash Point: Not established (non-volatile solid)
Chemical Stability: Stable under recommended conditions
Reactivity Profile: Inert towards most reagents
Hazardous Reactions: May react with strong oxidizing agents
Conditions to Avoid: Heat, moisture, direct sunlight, strong acids/bases, oxidizers
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides under fire conditions
Polymerization: No hazardous polymerization expected
Acute Toxicity: Oral LD50 (rat) above 2000 mg/kg
Irritation: Possible eye, skin, respiratory irritation
Skin Sensitization: Not classified as a sensitizer, instances of rash possible
Carcinogenicity: Not known to be carcinogenic based on animal data
Mutagenicity: No genotoxicity detected in standard bacterial/mammalian cell tests
Reproductive Toxicity: No observed negative effect in standard animal models
Chronic Toxicity: No chronic toxicity in therapeutic context at recommended doses
Aquatic Toxicity: Low toxicity observed in acute aquatic tests
Persistence and Degradability: Not readily biodegradable, some environmental persistence
Bioaccumulative Potential: Low to moderate (log Kow ~2.5)
Mobility in Soil: Limited, binds to sediment
Other Adverse Effects: No significant environmental hazards noted in standard screenings
Disposal of Waste: Use an approved facility for chemical waste, do not discharge to natural waters or drains
Container Disposal: Empty containers should be triple-rinsed, then disposed as pharmaceutical waste
Special Precautions: Incineration recommended for large volumes, ensure local environmental compliance
UN Number: Not regulated as dangerous goods
Proper Shipping Name: Not hazardous under transport rules
Hazard Class: None assigned
Packing Group: Not applicable
Environmental Hazards: Avoid accidental aquatic release
Transport Precautions: Store in original containers, ensure packaging resists breakage and moisture
Status: Active pharmaceutical ingredient, subject to medicine regulatory agency oversight
Labelling Requirements: Standard precautionary and hazard information for handling APIs, not classified under OSHA or EU CLP as hazardous
SARA/Title III – Section 313: Not listed
California Proposition 65: Not listed
REACH Status (EU): Registration exemption under medicinal use
Other Regulations: Adherence to national and local chemical regulations mandatory
