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Product Name: Isavuconazole Intermediate 8
Chemical Formula: Proprietary information
Recommended Use: Pharmaceutical intermediate in synthesis of Isavuconazole
Manufacturer: [Name Redacted for Privacy]
Address: [Redacted for Privacy]
Phone Number: [Redacted for Privacy]
Emergency Contact: [Redacted for Privacy]
SDS Number: [Redacted for Privacy]
Synonyms: Isavuconazole Key Intermediate, Intermediate 8
Shipment Identification: Follow internal batch and lot number labeling to ensure accurate traceability
Hazard Classification: Not fully assessed, presumed irritating to eyes, skin, and respiratory tract due to structural similarity to other azole intermediates
Signal Word: Warning
Pictograms: Exclamation Mark, Health Hazard if available
Hazard Statements: Causes skin irritation; causes serious eye irritation; may cause respiratory irritation
Precautionary Statements: Avoid breathing dust; wash skin thoroughly after handling; use only outdoors or in a well-ventilated area; wear protective gloves and eye protection
Other Hazards: Dust may form explosive mixtures with air
NFPA Ratings: Health: 2, Flammability: 1, Reactivity: 0
Chemical Name: Isavuconazole Intermediate 8
CAS Number: [Redacted for Privacy]
Concentration: Greater than 98% by weight
Impurities: Trace organic byproducts linked to synthetic route, less than 2% by GC
Other Ingredients: None
Ingredient Disclosure: Proprietary intermediate, trade secret protection in place under regulatory policies
Molecular Structure: Not public, part of licensed process information
Eye Contact: Rinse immediately with plenty of water, check for contact lenses and remove if possible, call physician if irritation persists
Skin Contact: Remove contaminated clothing; wash skin with plenty of soap and water; seek medical help if skin irritation or rash develops
Inhalation: Move person to fresh air, assist breathing if needed, call for medical help if symptoms like coughing, shortness of breath or wheezing occur
Ingestion: Rinse mouth with water, do not induce vomiting, get medical attention if large amounts swallowed or if person feels unwell
General Advice: Show this safety data sheet to the doctor in attendance
Most Important Symptoms: Red skin, eye watering, sneezing, difficulty breathing in sensitive individuals
Suitable Extinguishing Media: Dry chemical, water spray, foam, or carbon dioxide
Unsuitable Extinguishing Media: Do not use high pressure water stream to avoid dust formation
Hazardous Combustion Products: Oxides of carbon, nitrogen compounds, possible hazardous organic decomposition products
Special Protective Equipment for Firefighters: Full protective clothing including NIOSH approved self-contained breathing apparatus
Specific Hazards: Dust accumulation may present fire or explosion hazard; toxic fumes may be released on burning
Advice for Firefighters: Use water spray to cool unopened containers, keep safe distance, prevent runoff from entering water supplies or drains
Personal Precautions: Wear appropriate personal protective equipment including gloves, goggles, dust respirator
Environmental Precautions: Prevent further leakage or spillage, do not allow product to reach soil, sewers, or waterways
Containment Methods: Sweep up using non-sparking tools, avoid dust generation, transfer to a suitable labeled waste container
Cleaning Methods: Clean contaminated surface thoroughly using damp cloths; dispose contaminated materials as hazardous waste
Notification Procedures: Notify environmental authorities if large quantities enter water or soil
Evacuation: Remove unprotected personnel from area until cleaning complete
Handling: Avoid contact with skin and eyes, do not breathe dust, minimize dust generation, open containers carefully
Hygiene Practices: Wash hands and face before breaks, after handling, and before eating or drinking
Storage Conditions: Store in tightly closed containers, in a dry, well-ventilated place, away from sources of ignition, heat, and sunlight
Incompatibilities: Strong oxidizers, acids, and bases
Packaging Materials: Use corrosion-resistant, tightly sealed containers; clearly label for inventory management
Specific Use Considerations: Only trained personnel handle intermediate substances
Occupational Exposure Limits: No established limits for intermediate 8; use as low as reasonably achievable (ALARA) approach
Engineering Controls: Use in fume hood or local exhaust ventilation; provide safety showers and eyewash stations
Personal Protective Equipment (PPE): Chemical-resistant gloves, lab coats or apron, safety goggles, approved dust respirator
Thermal Hazards: Not anticipated in normal operations
Monitoring Procedures: Routine air monitoring for dust; surface wipe tests for GMP compliance
Environmental Exposure Controls: Prevent runoff into drains, operate under contained conditions
Appearance: White to off-white crystalline powder
Odor: Mild or negligible
Odor Threshold: Not established
pH: Not determined
Melting Point / Freezing Point: Estimated in range 120–150°C (varies batch to batch)
Boiling Point: Decomposes before boiling
Flash Point: Not tested, presume above 100°C
Evaporation Rate: Not applicable
Flammability: Not highly flammable but dust may pose explosion hazard
Upper/Lower Flammability or Explosive Limits: Data unavailable; avoid dust clouds
Vapor Pressure: Not applicable (non-volatile solid)
Vapor Density: Not applicable
Solubility: Slightly soluble in water; soluble in DMSO, DMF, some alcohols
Partition Coefficient (n-octanol/water): Not tested
Auto-ignition Temperature: No established data
Decomposition Temperature: Above estimated melting point
Viscosity: Not applicable (solid)
Chemical Stability: Stable under recommended storage conditions
Reactivity: Unlikely to react violently under normal handling
Hazardous Reactions: May react with strong oxidizing agents
Conditions to Avoid: Excessive heat, direct sunlight, exposure to moisture, open flame
Incompatible Materials: Oxidizers, acids, strong bases
Hazardous Decomposition Products: Carbon oxides, nitrogen oxides, unknown toxic organics if burned or thermally decomposed
Polymerization: Not expected under standard lab or manufacturing conditions
Routes of Exposure: Eyes, skin, inhalation, ingestion
Acute Toxicity: No data for intermediate 8; similar substances show moderate irritation in animals
Skin Corrosion/Irritation: May cause redness, swelling, itchiness
Eye Damage/Irritation: Irritating, can cause watering, redness
Respiratory Sensitization: Possible risk of respiratory irritation if inhaled as powder
Carcinogenicity: No data; not listed on IARC, NTP, or OSHA regulated carcinogens
Germ Cell Mutagenicity: No available data for intermediate
Reproductive Toxicity: Not tested for reproductive or developmental effects
Target Organs: Eyes, skin, respiratory tract
Symptoms: Cough, throat irritation, sneezing, eye and skin reddening
Chronic Effects: No long-term studies available
Ecotoxicity: No test results for specific intermediate; structurally related azoles show moderate toxicity to aquatic life
Persistence and Degradability: Not readily biodegradable; intermediate could persist in soil and water
Bioaccumulative Potential: Bioaccumulation of parent azoles reported in some species
Mobility in Soil: Moderate, depends on organic content of substrate
Aquatic Toxicity: Likely toxic to some freshwater organisms, recommended limit discharge to industrial systems
Other Adverse Effects: Avoid release to environment, treat as hazardous for regulatory reporting
Wastewater Considerations: Avoid discharge to public water systems, collect and treat industrial streams before disposal
Waste Treatment Methods: Collect as hazardous chemical waste according to local and national regulations
Disposal Containers: Use labeled, sealed containers made from compatible materials
Recycling Options: Not suitable for recycling; offering for specialized incineration as hazardous waste is recommended
Disposal Precautions: Wear PPE, avoid contact, and prevent dust formation during transfer
Contaminated Packaging: Dispose of as hazardous waste; do not reuse for other materials
Regulations: Comply with all relevant environmental, municipal, and industrial waste guidelines
Special Disposal Instructions: Notify authorities if large spills occur or if unusual health or environmental hazards detected during disposal
UN Number: Not assigned for this intermediate
UN Proper Shipping Name: Chemical substance, n.o.s. (Isavuconazole Intermediate 8)
Transport Hazard Class: Not regulated as dangerous for transport according to current regulations
Packing Group: Not classified
Environmental Hazards: Not classified as marine pollutant but handle spills carefully
Special Precautions for User: Use sealed, labeled containers, secure during transport, avoid temperature extremes
Transport by Road/Rail/Air/Sea: Follow company’s Standard Operating Procedures, keep away from incompatible chemicals, ensure traceability and chain of custody in all shipping documents
OSHA Status: Not specifically regulated under OSHA hazardous chemical rules
TSCA Inventory: Not listed, confidential business information
REACH Status: Not registered, exemption possible due to intermediate use only
Other Regulations: Subject to pharmaceutical industry guidelines for API intermediates, may require notification under national pollutant release inventory laws
SARA 313: Not listed among toxic chemicals
California Prop 65: Not listed
GHS Classification: Classified based on hazard assessment, see previous sections
Workplace Control: Follow internal control procedures for handling pharmaceutical intermediates; regulated documentation for every shipment and storage location
