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Product Name: Roxadustat
Chemical Name: 5-[(4-Hydroxy-1-methyl-7-phenoxyisoquinolin-3-yl)carbonyl]-1-methyl-3-phenylpyridin-2(1H)-one
Synonyms: FG-4592
Recommended Use: Pharmaceutical ingredient for chronic kidney disease-associated anemia
Manufacturer: Please consult the manufacturer’s label for relevant contact details
CAS Number: 808118-40-3
Emergency Contact: Refer to local poison center or regulatory authorities for immediate assistance in case of exposure
GHS Classification: Acute toxicity, oral (Category 4); Specific target organ toxicity, single exposure (Category 3)
Pictogram: Exclamation mark
Signal Word: Warning
Hazard Statements: Harmful if swallowed; May cause respiratory irritation
Precautionary Statements: Avoid breathing dust or particles; Use only outdoors or in a well-ventilated area; Wash hands thoroughly after handling; Do not eat, drink, or smoke when using this product
Potential Health Effects: Eyes: May cause mild to moderate irritation; Skin: Possible slight irritation; Inhalation: May trigger respiratory tract discomfort
Note on Sensitization: Allergic skin reactions are unlikely, but cannot be excluded without detailed study
Environmental Hazards: May be toxic to aquatic organisms with long-lasting effects
Component: Roxadustat
Chemical Formula: C19H16N2O5
Concentration: >98% (as pharmaceutical active ingredient)
Impurities: Related isoquinoline and pyridinone derivatives (<2%)
Additives: None detected in raw powder
Physical Form: White to slightly off-white powder
Other Identifiers: No known hazardous polymers, carriers, or diluents in pure substance format
General advice: Remove affected individual from exposure area to fresh air immediately
If inhaled: Move to fresh air; seek medical attention if symptoms persist
If skin contact: Remove contaminated clothing, rinse skin with soap and water for at least 15 minutes
If eye contact: Rinse cautiously with water for several minutes; remove contact lenses if present and easy; continue rinsing
If swallowed: Rinse mouth; do not induce vomiting; seek medical attention
Most important symptoms and effects: May include nausea, headache, respiratory irritation, mild gastric discomfort
Notes to physician: Treat symptoms as observed; no specific antidote recommended
Suitable extinguishing media: Water spray, dry chemical powder, carbon dioxide, foam
Unsuitable extinguishing media: Avoid direct water jet
Hazardous combustion products: Emits oxides of carbon, nitrogen oxides, potentially toxic fumes if heated to decomposition
Protective equipment: Full protective gear and self-contained breathing apparatus
Special precautions: Cool containers exposed to flames with water spray; prevent runoff from entering drains; stay upwind of fire; evacuate nonessential personnel
Personal precautions: Wear protective gloves, goggles, lab coat, and NIOSH-approved respirator when cleaning up spills
Spill response: Avoid dust generation and inhalation; ensure adequate ventilation; evacuate unnecessary personnel
Containment: Cover with inert absorbent material (e.g., dry sand, vermiculite), collect with non-sparking tools
Clean-up method: Sweep or shovel into suitable container for disposal; clean spill surface thoroughly with water and detergent
Environmental precautions: Prevent release to drains, water sources, or soil; notify authorities if large quantities enter waterways
Safe handling: Minimize generation and accumulation of dust; avoid contact with skin, eyes, and clothing; maintain good laboratory hygiene practices
Technical measures: Handle in chemical fume hood if available; use local exhaust ventilation
Storage conditions: Store locked up, in a tightly sealed container, out of direct sunlight, below 30°C (86°F)
Incompatible substances: Strong oxidizers, acids, bases
Specific end use: For research, pharmaceutical production, or analysis by trained professionals only
Occupational exposure limits: Not established by OSHA, ACGIH, or NIOSH
Engineering controls: Use with adequate local exhaust ventilation or chemical fume hood; install eyewash and safety shower near work area
Personal protection: Safety glasses or goggles, nitrile gloves, lab coat, NIOSH-approved dust respirator (P3 filter recommended)
Hygiene measures: Do not eat, drink, or smoke during use; wash hands thoroughly afterward; avoid contact with clothing
Appearance: White to off-white crystalline powder
Odor: Odorless or faint chemical smell
Odor threshold: Not determined
pH: Not applicable (insoluble in water)
Melting point/freezing point: 220-230°C
Boiling point: Decomposes before boiling
Flash point: Not flammable in solid form
Evaporation rate: Not applicable
Flammability: Not highly flammable but dust may form explosive mixtures with air
Upper/lower explosive limits: Data not available
Vapor pressure: Not available
Solubility in water: Poorly soluble (<1 mg/mL); more soluble in organic solvents (DMSO, methanol)
Partition coefficient (log Pow): 2.3
Vapor density: Not applicable
Relative density: 1.33 (approximate)
Auto-ignition temperature: Not available
Decomposition temperature: >200°C
Viscosity: Not applicable
Chemical stability: Stable under recommended storage and handling conditions
Reactivity: Not reactive under normal lab and storage conditions
Hazardous reactions: Avoid strong acids, bases, or oxidizers; degradation possible at high temperatures
Conditions to avoid: Excess heat, open flames, moisture, direct sunlight
Hazardous decomposition products: May form carbon monoxide, carbon dioxide, and nitrogen oxides on combustion
Polymerization: No hazardous polymerization anticipated
Likely routes of exposure: Inhalation, dermal, ocular, ingestion
Acute toxicity: Estimated oral LD₅₀ (rat): 500-2,000 mg/kg
Skin irritation: Mild irritation possible in sensitive individuals
Eye irritation: Likely mild to moderate transient irritation
Respiratory effects: Dust may irritate upper airways
Chronic exposure: No published carcinogenicity data; repeat dose studies in animals show hemoglobin and iron metabolism changes
Reproductive/developmental effects: Data limited; consult scientific literature for latest findings
Mutagenicity: Studies to date do not show mutagenic potential
Symptoms: Headache, nausea, dizziness, mild gastrointestinal upset
Ecotoxicity: Aquatic: toxic to fish and daphnid at mg/L levels; soil: unknown persistence
Persistence and degradability: Stable under typical environmental conditions; slow to degrade
Bioaccumulative potential: Moderate potential, based on log Pow; not expected to bioconcentrate significantly
Mobility in soil: Low solubility limits rapid movement
Other adverse effects: Avoid direct release into waterways; effects on sewage and treatment microbes untested
Waste treatment methods: Dispose of via licensed chemical waste contractor
Disposal of product: Destroy by incineration in accordance with local regulations; do not discharge to drain or environment
Disposal of packaging: Triple rinse, then offer for recycling or disposal as hazardous waste
Environmental precautions: Small powder amounts should not enter watercourses, sewers, or soil; prevent bulk disposal outside regulatory compliance
UN Number: Not assigned
UN Proper Shipping Name: Not regulated for ground, air, or sea transport when shipped in non-bulk packaging
Transport hazard class(es): Not classified
Packing group: Not regulated
Environmental hazards: Not classified as marine pollutant
Special precautions for user: Package securely to prevent spillage; keep away from food and feedstuffs; refer to shipping documentation for any specific local requirements
US TSCA Status: Not listed for commercial distribution
FDA (USA): Approved active ingredient for specific prescription uses
EU REACH Status: Meets requirements for pharmaceutical exemption under Annex IV/V
WHMIS (Canada): Not classified as hazardous
Other regulatory listings: Consult local, regional, and national authorities for registration status
Labeling requirements: Reference to safety data sheet required for workplace use; avoid uncontrolled release
