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Product Name: Darunavir Ethanolate
Chemical Family: Antiviral agent, Protease inhibitor
Chemical Formula: C27H37N3O7S·C2H6O
Synonyms: TMC114 Ethanolate, Prezista Ethanolate
Recommended Use: Pharmaceutical intermediate for HIV therapy
Manufacturer: [Insert Manufacturer Details]
CAS Number: 635728-49-3
Emergency Contact: [Insert Emergency Contact Number]
GHS Classification: Acute toxicity (oral, dermal, inhalation), Skin sensitization, Eye irritation
Signal Word: Warning
Hazard Statements: Harmful if swallowed or inhaled; May cause an allergic skin reaction; Causes serious eye irritation; May cause respiratory irritation
Pictograms: Exclamation mark, Health hazard symbol
Precautionary Statements: Avoid breathing dust; Wash skin thoroughly after handling; Wear protective gloves and eye protection; Use only with adequate ventilation
Primary Routes of Exposure: Inhalation, skin contact, ingestion, eye contact
Chemical Identity: Darunavir Ethanolate
Concentration: ≥98% pure (typically as ethanolate solid)
Impurities / Additives: None expected at relevant levels
Molecular Weight: 593.72 g/mol (free base); includes ethanol
CAS Component: Darunavir Ethanolate – 635728-49-3
Inhalation: Move person outdoors; provide fresh air and keep rest position; seek medical attention if symptoms arise.
Skin Contact: Remove contaminated clothing; rinse affected skin with water and soap; get medical advice for irritation.
Eye Contact: Flush with water for at least 15 minutes lifting lids; remove contacts if present and easy; medical help if discomfort continues.
Ingestion: Rinse mouth; do not induce vomiting; drink plenty of water; immediate medical attention is necessary.
Most Important Symptoms: May cause respiratory tract discomfort, skin rash, eye redness, gastrointestinal upset.
Suitable Extinguishing Media: CO₂, dry chemical, foam, water spray
Specific Hazards: Product can release toxic fumes: nitrogen oxides, sulfur oxides, carbon monoxide & carbon dioxide when burned
Protective Equipment: Self-contained breathing apparatus, full firefighting gear
Special Procedures: Prevent runoff from entering drains; cool containers with water spray; avoid inhalation of smoke or combustion products
Personal Precautions: Wear safety goggles, nitrile gloves, and dust mask; avoid dust generation.
Spill Cleanup: Use damp cloth or HEPA-filter vacuum to collect spilled solid; transfer to a sealed waste container; ventilate area.
Environmental Precautions: Block release into drains and watercourses; notify authorities if large spills reach waterways.
Handling: Handle under local exhaust; avoid direct contact with skin, eyes, and clothing; do not eat, drink, or smoke when using.
Storage Conditions: Keep container tightly closed; store in a cool, dark, dry place (<25°C); protect from light and moisture
Incompatible Substances: Strong oxidizers, acids, bases
Hygienic Practices: Wash hands after handling; maintain good laboratory practices
Exposure Limits: No occupational exposure limits established by OSHA, ACGIH, or NIOSH for Darunavir Ethanolate
Engineering Controls: Use in chemical fume hood; maintain adequate local exhaust
Personal Protective Equipment: Chemical resistant gloves (nitrile or latex), safety glasses, lab coat
Respiratory Protection: Dust mask or respirator (NIOSH-approved) in case of dust formation or inadequate ventilation
Workplace Hygiene: No eating or drinking during material handling; change contaminated clothing promptly
Physical State: Solid (fine crystalline powder)
Color: White to off-white
Odor: Odorless to mild alcohol odor owing to ethanolate
pH: Not applicable (solid form)
Melting Point: 70-75°C (with ethanol lost <60°C)
Boiling Point: Not applicable (decomposes before boiling)
Flash Point: Not available
Solubility: Slightly soluble in water; soluble in DMSO, methanol
Vapor Pressure: Not relevant
Partition Coefficient (log P): ~2.0
Decomposition Temperature: >150°C
Evaporation Rate: Not applicable
Chemical Stability: Stable under normal storage and handling; sensitive to heat, moisture, light over time
Conditions to Avoid: Humidity, elevated temperatures, sunlight, strong oxidizers
Hazardous Decomposition: Toxic fumes: nitrogen oxides, sulfur oxides, carbon oxides on combustion
Reactivity: No significant reactivity under recommended handling
Polymerization: Not anticipated
Plausible Routes of Entry: Inhalation, ingestion, skin and eye contact
Acute Toxicity: Not fully established; animal tests suggest mild to moderate toxicity at high doses
Skin Sensitization: May cause allergic skin reaction in sensitive individuals
Eye Effects: Irritating to eyes
Cancer Risk: No human data; animal studies do not suggest carcinogenicity
Reproductive Toxicity: Limited, but adverse developmental effects not well studied
Repeated Dose Toxicity: May damage liver at high exposure in test animals
Signs of Overexposure: Nausea, headache, skin irritation, rash, respiratory discomfort, eye redness
Aquatic Toxicity: Limited data; possible mild acute toxicity to aquatic organisms
Bioaccumulation: Not expected to bioaccumulate due to moderate Log P
Environmental Fate: Persistence may arise; degradability not fully determined
Mobility in Soil: Moderate; no specific migration data available
Other Harmful Effects: No known significant effects; recommend minimizing environmental release
Waste Disposal: Observe all local and national environmental regulations; incinerate in a facility approved for hazardous pharmaceutical waste
Container Disposal: Triple rinse empty containers and dispose as hazardous chemical waste
Special Precautions: Do not pour into drains or waterways; avoid generation of dust during disposal
Recommended Disposal Method: High-temperature incineration
UN Number: Not regulated as a dangerous good under UN, IATA, IMDG, DOT
Proper Shipping Name: Pharmaceutical intermediate (not classified as dangerous cargo)
Transport Hazard Classes: Not applicable
Packing Group: Not applicable
Special Precautions: Avoid contact with incompatible materials during transit; store in original container; protect against physical damage
Safety, Health, and Environmental Regulations: Product not specifically listed under TSCA, DSL, or EINECS, but pharmaceutical use falls under FDA regulations.
Hazard Categories (US, SARA): No reportable quantities established
Labeling Requirements: GHS compliant marking; hazard and precautionary statements included
Other Regulations: Follow country-specific guidelines for handling, disposal, and transport
