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Product Name: Ritonavir Intermediate 8; (1S,3S,4S)-4-Amino-3-Hydroxy-5-Phenyl-1-(Phenylmethyl)Pentyl-Carbamic Acid Tert-Butyl Ester; (2S,3S,5S)-5-(Tert-Butoxycarbonyl)Amino-2-Amino-3-Hydroxy-1,6-Diphenylhexane
Chemical Formula: C28H38N2O4
Synonyms: Boc-(1S,3S,4S)-4-Amino-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl-carbamate
Intended Use: Factory chemical synthesis stage intermediate for ritonavir production
Supplier Identification: Manufacturer address and emergency phone contact—displayed on label and shipping papers
Recommended Restrictions: For laboratory, pilot-plant, and manufacturing use under expert industrial supervision only
Classification: GHS skin sensitizer Category 1, eye irritant Category 2A, specific target organ toxicity (single exposure) Category 3, chronic aquatic toxicity Category 3
Signal Word: Warning
Hazard Statements: May cause skin or eye irritation, possible allergic reactions after repeated exposure, could trigger respiratory irritation, suspected of causing damage to organs with repeated occupational exposure, harmful to aquatic life with long-lasting effects
Precautionary Statements: Avoid breathing dust, use safety glasses and gloves, wash skin thoroughly after handling, prevent product runoff into soil and watercourses
Typical Route of Exposure: Inhalation of powder, skin absorption, eye contact, accidental ingestion
Chemical component: Ritonavir Intermediate 8
CAS Number: Not assigned yet for this intermediate
Concentration/Content: 95%–99% (by weight as manufactured)
Impurities: Trace synthetic byproducts (<0.5%), t-butanol residues, other non-specified substances present in minimal percentages, not expected to raise risk above baseline
Other Ingredients: No stabilizers or solvents present in standard supplied format
Eye Contact: Rinse cautiously with plenty of water for at least 10–15 minutes while holding eyelids open, remove contact lenses if easy and continue rinsing, seek medical attention
Skin Contact: Remove exposed clothing, rinse skin with soap and water, do not reuse soiled garments until thoroughly cleaned, get medical attention for persistent or blistering symptoms
Inhalation: Move person away from source to fresh air, loosen tight clothing, offer oxygen if experiencing respiratory distress, call for medical support especially if coughing or throat irritation persists
Ingestion: Rinse mouth with water, drink small amounts of water to dilute, do not give anything by mouth if unconscious, never induce vomiting unless directed by a physician or poison control, seek immediate medical help
Additional Advice: Show MSDS or product label to first responders and healthcare professionals
Suitable Extinguishing Media: Dry chemical powder, carbon dioxide (CO2), alcohol-resistant foam, water spray for larger fires to cool containers
Unsuitable Media: Direct water stream may spread powder, avoid high-pressure water applications
Special Hazards: Combustion may produce irritating or toxic fumes such as nitrogen oxides, carbon monoxide, carbon dioxide, particulate matter
Advice for Firefighters: Wear full self-contained breathing apparatus and protective suit, prevent contaminated runoff from entering drains or waterways, evacuate non-essential personnel from area
Personal Precautions: Wear chemical splash goggles, chemical-resistant gloves, and protective clothing, avoid breathing dust, ventilate area
Environmental Precautions: Avoid release into sewers, surface water, or soils, report uncontrolled releases to responsible authorities
Methods for Clean-Up: Collect spilled powder using a vacuum with HEPA filter or damp wisps, shovel into labeled waste container, wash spill site with detergent and water after material pickup
Disposal of Contaminated Material: Send cleanup residues for hazardous waste disposal as directed by local regulations, avoid flushing to drains
Safe Handling: Limit dust generation, use local exhaust ventilation, wear recommended personal protection, keep away from food, beverages, and incompatible substances
Storage Conditions: Store in tightly closed containers under nitrogen or inert atmosphere if possible, keep dry and between 2–8°C, protect from light and moisture, avoid excessive heat
Incompatibilities: Strong oxidizers, strong acids, alkali substances, prolonged contact with open air can accelerate decomposition
Labeling: Ensure proper hazard labeling and restricted access to trained personnel
Engineering Controls: Local exhaust ventilation or fume extraction recommended at points of possible dust release, safe work practices to minimize dust spread
Personal Protective Equipment (PPE): Nitrile or butyl rubber gloves, laboratory coat, safety glasses or goggles, NIOSH-approved dust respirator if airborne powder may exceed nuisance levels, closed footwear
Hygiene Measures: Wash hands and face after handling, do not eat, drink, or smoke in work area, separate contaminated clothing from personal laundry
Occupational Exposure Limits: No occupational exposure limits established; treat as non-specific organic powder, keep below 10 mg/m³ particulate, consult industrial hygienists for workplace monitoring
Appearance: Off-white to slightly yellow crystalline powder
Odor: Faint, not distinctive
pH: Not applicable (solid formulation)
Boiling Point: Not measured (decomposes before boiling)
Melting Point: Estimated 90–110°C (decomposition at higher temperature possible)
Flash Point: >100°C estimated
Solubility: Practically insoluble in water, soluble in polar organic solvents such as DMSO, methanol, ethanol
Vapor Pressure: Negligible at room temperature
Partition Coefficient (log Kow): Not available; structurally expected to be moderate to high due to aromatic and tert-butyl groups
Other Properties: Stable in closed containers under recommended conditions, no explosive or oxidizing properties anticipated
Chemical Stability: Stable under ambient conditions, especially in original container
Thermal Decomposition: Decomposes at elevated temperature releasing carbon, nitrogen oxides, and potentially trace phenolic byproducts
Reactivity: Not sensitive to static discharge or mechanical shock, avoid strong acids, oxidizers, alkali agents that can produce exothermic reactions
Possibility of Hazardous Reactions: Contact with moisture and heat may accelerate breakdown, extended exposure to air can reduce shelf life
Incompatible Materials: Avoid strong oxidants, concentrated mineral acids, strong bases
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, hydrocarbons if fire or high-temperature breakdown occurs
Acute Toxicity: Not thoroughly tested, structurally related to materials of low acute oral and dermal toxicity in animal models; respiratory, skin, and eye irritation documented for similar compounds
Skin Sensitization: May cause allergic skin reactions in susceptible individuals with repeated handling
Eye Effects: Can cause redness or irritation, do not rub eyes if exposed
Carcinogenicity: Not classified as carcinogen by ACGIH, IARC, NTP, or OSHA
Reproductive Toxicity: No direct data, structural activity suggests low reproductive hazard for short, professional use
Potential Health Effects: Respiratory irritation, mild headache, nausea, possible transient kidney/liver effects if chronically misused
Symptoms from Exposure: May include itching, skin rash, tearing, sore throat, cough
Other Effects: Chronic exposure may sensitize individuals, leading to stronger allergic reactions upon future contact
Ecotoxicity: Harmful to aquatic organisms, possible long-term adverse effects in aquatic environment in case of significant contamination
Persistence/Degradability: Expected to degrade slowly in soil and water due to branching and aromatic rings
Bioaccumulation: Limited data, structure indicates potential for moderate accumulation in organisms over time
Mobility in Soil: Limited by low water solubility, expected to bind to soils and sediments
Other Effects: No evidence for biomagnification, not expected to evaporate or move through air easily; environmental release should always be prevented
Waste Disposal Methods: Dispose of as hazardous organic chemical waste through licensed contractor, packaging and containers must be triple rinsed or thoroughly cleaned before recycling if allowed
Unused Product: Do not dump into drains, soil, or surface water, use approved incineration or chemical waste destruction
Contaminated Packaging: Treat as hazardous residue, do not reuse for food, pharmaceuticals, or drinking water
Legal Requirements: Comply with local, state, and federal hazardous waste management regulations for storage and disposal
UN Number: Not assigned for this intermediate chemical
Proper Shipping Name: Organic solid, N.O.S. (contains tert-butoxycarbonyl amino hexane derivative)
Hazard Class: 6.1 (Toxic), packing group III (moderate hazard)
Labels and Marks: Class 6.1 toxic label, environmental hazard symbol where mandated
Special Precautions: Avoid temperature extremes, prevent package rupture, protect from humidity, keep in original container
Transport in Bulk: Not applicable (laboratory and commercial shipping stable in drum, kegs, or sealer pouches)
TSCA Status: May not be listed on US Toxic Substances Control Act inventory as it is a custom pharmaceutical intermediate
DSL/NDSL: Not anticipated to be listed in Canada DSL/NDSL
European Inventory: Registration required under REACH for quantities over research use, subject to exemption for on-site isolated intermediates
OSHA Hazard Communication: Classified hazardous by OSHA for workplace use
Other Regulations: Handle using good laboratory and manufacturing practice (GLP, GMP) protocols as defined by FDA/EMA for active pharmaceutical ingredient manufacture; observe additional requirements for waste, emission, and worker health under local authority enforcement
