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Product Name: Darunavir
Chemical Name: (S)-N-[(2R,3R)-4-(dimethylcarbamoyl)-3-hydroxy-1-phenylbutan-2-yl]-2-hydroxy-3-((4-(pyridin-2-yl)benzyl)oxy)sulfonamide
Synonyms: TMC114, Prezista
CAS Number: 206361-99-1
Molecular Formula: C27H37N3O7S
Molecular Weight: 547.67 g/mol
Recommended Uses: Antiretroviral drug, HIV protease inhibitor
Supplier: Various pharmaceutical companies
Emergency Contact: Refer to local regulations or manufacturer safety line
Manufacturing Location: Typically listed on packaging or supply documents
Classification: Not classed as hazardous under OSHA or EU GHS/CLP guidelines for handling bulk pharmaceutical ingredients
Physical Hazards: Dust generation during processing, moderate particulate irritant
Health Hazards: May cause eye irritation, skin sensitivity, or respiratory irritation in sensitive individuals
Environmental Hazards: Limited data, not highly toxic but requires containment to prevent aquatic release
Specific Hazards: Possible allergic reactions with chronic direct contact
Signal Word: No signal word assigned
Pictograms: Not required by most regulatory authorities for primary form
Main Ingredient: Darunavir (active pharmaceutical ingredient), pure compound
Concentration: Typically >98% by weight as bulk API
Impurities: ≤2% (details available on COA, certificate of analysis)
Formulation Additives: Not present in API, but may include cellulose derivatives, starch, or magnesium stearate in dosage form
CAS Number: 206361-99-1
Inhalation: Move exposed person to fresh air, monitor breathing, seek medical attention for persistent symptoms
Skin Contact: Wash area with plenty of soap and water, remove contaminated clothing
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses, continue rinsing, see physician if discomfort persists
Ingestion: Rinse mouth, drink plenty of water, seek medical help, do not induce vomiting unless directed by medical personnel
Note to Physician: Treat symptomatically, monitor for delayed hypersensitivity reactions
Suitable Extinguishing Media: Water spray, foam, carbon dioxide (CO2), dry chemical
Unsuitable Media: Strong water jets may spread powder
Hazardous Combustion Products: Carbon monoxide, nitrogen oxides, sulfur oxides, unidentified organic compounds
Protective Equipment for Firefighters: Full protective clothing, self-contained breathing apparatus
Special Firefighting Procedures: Avoid inhaling combustion gases; isolate and cool area
Personal Precautions: Wear protective gloves, goggles, dust mask or respirator
Environmental Precautions: Prevent powder from entering sewers, drains, watercourses
Cleanup Methods: Collect spillage with a HEPA-filter vacuum or damp wipe, place in sealed containers for disposal
Spill Reporting: Notify appropriate local authorities according to regulatory requirements
Protective Measures: Minimize dust formation, use in well-ventilated area, avoid inhalation and direct skin/eye contact
Technical Handling: Use local exhaust or process enclosure when transferring bulk powder
Storage Requirements: Keep containers tightly closed in a cool, dry, well-ventilated place
Storage Temperature: 15-30°C, away from light and incompatible materials
Incompatible Materials: Strong oxidizing agents, bases, acids
Hygiene Practices: Wash hands thoroughly after handling, remove contaminated clothing
Engineering Controls: Use process enclosures, local exhaust ventilation
Exposure Limits: Occupational exposure limit not established; minimize exposure using good industrial hygiene practices
Respiratory Protection: Use approved respirator if dust or airborne concentrations are generated
Hand Protection: Chemical-resistant gloves (nitrile, latex)
Eye Protection: Safety goggles or face shield
Skin Protection: Long-sleeved clothing, lab coat
Environmental Controls: Prevent release to environment, use containment systems
Appearance: White or off-white crystalline powder
Odor: Odorless or faint chemical smell
Melting Point: 74-85°C
Boiling Point: Not applicable (decomposes before boiling)
Sublimation Point: Not reported
pH: Neutral (not applicable for solid powder)
Solubility: Poorly soluble in water; soluble in DMSO, methanol, ethanol
Partition Coefficient (logP): 2.3-2.6 (lipophilic)
Vapor Pressure: Negligible at room temperature
Relative Density: Approximately 1.3 g/cm³
Flash Point: Not applicable
Auto-ignition Temperature: Not determined
Stability: Stable under recommended storage conditions
Thermal Decomposition: Decomposes on heating, liberating toxic fumes
Incompatible Materials: Strong acids and oxidizers
Reactivity: Low chemical reactivity with most materials under standard conditions
Hazardous Reactions: No polymerization or violent decomposition expected
Hazardous Decomposition Products: CO, CO₂, nitrogen oxides, sulfur oxides
Acute Toxicity: Low toxicity by oral route in animal studies (oral LD₅₀ >2000 mg/kg in rats)
Chronic Toxicity: No significant chronic toxicity identified at therapeutic dose ranges
Routes of Exposure: Inhalation of dust, accidental ingestion, skin or eye contact
Symptoms of Exposure: May cause eye and respiratory irritation, mild skin sensitivity
Carcinogenicity: Not classified as carcinogen by IARC, NTP, OSHA
Mutagenicity: No evidence of mutagenic effects in standard tests
Reproductive Effects: No significant reproductive or teratogenic effects in animal studies
Sensitization: May cause allergic skin or respiratory reactions in predisposed individuals
Ecotoxicity: Limited data available; low predicted toxicity in aquatic organisms based on structure-activity analysis
Persistence and Degradability: Moderately persistent in environment; not readily biodegradable
Bioaccumulative Potential: Potential for low bioaccumulation due to low solubility and logP
Mobility in Soil: Low to moderate mobility due to partial solubility
Other Adverse Effects: No known significant effects or hazards to the environment at therapeutic concentrations, larger accidental releases require cleanup
Waste Disposal Methods: Incinerate or landfill in accordance with local, regional, and national regulations for pharmaceutical waste
Incineration Requirements: Use licensed chemical incinerators equipped with emission controls
Packaging Disposal: Dispose of contaminated packaging as hazardous pharmaceutical waste
Special Precautions: Do not discharge into drains or environment, avoid dust formation during disposal process
UN Number: Not regulated for road, rail, air, or sea transport as a hazardous material
Proper Shipping Name: Not classified
Hazard Class: None
Packing Group: None
Labeling Requirements: No hazard labeling required
Special Precautions for Transport: Protect from extreme heat and humidity, keep packaging sealed to avoid leakage of powder
OSHA Hazard Status: Not hazardous/
TSCA Inventory: Exempt as pharmaceutical ingredient
EU REACH Status: Not required for APIs marketed as medicines
WHMIS (Canada): Not classified
California Proposition 65: Not listed
Other Regulations: Compliant with Good Manufacturing Practice (GMP), controlled under pharmaceutical laws
Workplace Restrictions: Use only as directed, restrict use to trained professionals
