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Product Name: Upadacitinib
Chemical Name: (3S,4R)-3-Ethyl-4-[2-[1,6-dihydro-1-methyl-6-oxo-5-pyrimidinyl]ethynyl]-N-(2,2,2-trifluoroethyl)-2-pyrrolidinecarboxamide
Common Synonyms: ABT-494, RINVOQ
CAS Number: 1310726-60-3
Recommended Uses: Pharmaceutical intermediate, active pharmaceutical ingredient for the treatment of certain autoimmune conditions such as rheumatoid arthritis
Manufacturer/Supplier: AbbVie Inc.
Contact Information: Emergency and technical support lines available from supplier
GHS Classification: Reproductive toxicity, Category 2; Specific target organ toxicity (repeated exposure), Category 2
Signal Word: Warning
Hazard Statements: May cause damage to organs through prolonged or repeated exposure; Suspected of damaging fertility or the unborn child
Pictogram: Exclamation mark, Health hazard
Routes of Exposure: Inhalation, skin and eye contact, ingestion
Potential Health Effects: Eye, skin, and respiratory tract irritation; possible reproductive effects based on studies and workplace experience
Upadacitinib: 98–100%
Impurities: <2% (may include organic solvents, water, or starting materials)
Excipient Residues: None for bulk API; finished dosage forms not covered by this document
No hazardous solvents or additives reported for standard API packaging
Eye Contact: Rinse cautiously with water for several minutes; remove contact lenses if present and easy, continue rinsing
Skin Contact: Wash thoroughly with soap and water; remove contaminated clothing and seek medical attention if irritation persists
Inhalation: Move person to fresh air; offer respiratory support if symptoms like coughing, dizziness, or shortness of breath develop
Ingestion: Rinse mouth with water; never give anything by mouth to an unconscious person, seek immediate medical help
Most Important Symptoms: Irritation, drowsiness, headache, possible nausea or vomiting in overdose situations
Suitable Extinguishing Media: Dry chemical, carbon dioxide, foam, or water spray
Unsuitable Media: Do not use water jet if it may spread the material
Fire Hazards: Combustion yields carbon monoxide, carbon dioxide, hydrogen fluoride, nitrogen oxides, other toxic gases
Advice for Firefighters: Use full protective gear including self-contained breathing apparatus; avoid breathing vapors
Explosion Hazards: Dust generated during handling may form explosive mixtures with air in unventilated areas
Personal Precautions: Wear respiratory protection, gloves, goggles when cleaning spills; avoid dust formation and dispersal
Environmental Precautions: Prevent discharge to drains, surface and ground waters where possible
Spill Response: Vacuum or sweep up spills with methods minimizing airborne particles; place in secure, labeled waste containers for proper disposal
Decontamination: Clean area with suitable detergent and water; avoid re-entry until thoroughly cleaned
Safe Handling: Minimize dust generation, use local exhaust; work within chemical fume hood or ventilated enclosure for open handling
Hygiene Measures: Wash hands after use, avoid eating or drinking around material; keep away from incompatible substances such as strong oxidizers
Storage Conditions: Store in tightly closed original container in a cool, dry area away from light; recommended temperature ranges from 2–8°C for stability
Special Precautions: Signage and restricted entry to designated pharmaceutical storage areas; limit access to trained personnel
Engineering Controls: Local exhaust ventilation, closed system transfer, HEPA filtration for pharmaceutical powders
Eye Protection: Chemical splash goggles or face shield
Skin Protection: Disposable gloves, lab coats, chemical-resistant clothing if contact may occur
Respiratory Protection: NIOSH-approved respirator for inadequate ventilation or dust generation
Occupational Exposure Limit: AbbVie’s in-house OEL: typically 0.01–1 μg/m3 (proprietary values, consult site safety data)
Appearance: White to off-white crystalline powder
Molecular Formula: C17H19F3N6O2
Molecular Weight: Approximately 380.37 g/mol
Odor: Odorless
pH: Not applicable
Solubility: Freely soluble in DMF and DMSO, poorly soluble in water
Melting Point: 230–240°C
Boiling Point: Not determined (decomposes)
Vapor Pressure: Negligible at ambient conditions
Flash Point: Not flammable under normal use
Partition Coefficient (Log P): Estimated 2–4
Stability: Stable under recommended storage and normal conditions
Chemical Stability: Stable under ambient temperatures, protected from direct sunlight and moisture
Reactivity: Not expected to be reactive under standard conditions
Incompatible Materials: Strong oxidizing agents, acids, bases
Hazardous Decomposition Products: Carbon oxides, hydrogen fluoride, nitrogen oxides
Polymerization: Not expected under normal process conditions
Likely Routes of Exposure: Inhalation, dermal, ingestion, ocular
Acute Toxicity: Oral LD50 (rat): >2000 mg/kg (data from similar compounds and developer disclosures)
Skin Corrosivity/Irritation: May cause mild irritation
Eye Damage/Irritation: May cause slight to moderate irritation
Respiratory Sensitization: Not classified, chronic occupational exposure not fully studied
Germ Cell Mutagenicity: Not expected at occupational concentrations
Carcinogenicity: No findings in 2-year rodent studies at tested doses to date
Reproductive Toxicity: Animal studies indicate adverse reproductive effects at high doses; precaution advised
Target Organ Effects: Liver, lymph nodes, spleen in high-dose animal tests
Aquatic Toxicity: No acute aquatic toxicity expected at low environmental concentrations; fish, daphnia, and algae LC50/EC50 typically >100 mg/L
Persistence and Degradability: Partially degradable under aerobic conditions; some metabolites may persist
Bioaccumulative Potential: Low to moderate (estimated log P values suggest limited but possible accumulation in biota)
Mobility in Soil: Likely to sorb to soil; low mobility in case of accidental release
Other Adverse Effects: No known issues at trace environmental levels; appropriate pharmaceutical waste management recommended
Disposal Methods: Waste must go through licensed chemical or pharmaceutical incineration; do not release to sewer or natural water sources
Contaminated Packaging: Triple rinse and destroy by incineration or send to specialized hazardous waste facility
Special Precautions: Follow local, regional, and national environmental regulations governing pharmaceutical chemicals
UN Number: Not regulated as a hazardous material for air, ground, or sea transport under international conventions
Proper Shipping Name: Pharmaceutical product, not otherwise specified
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Special Precautions: Handle sealed containers to prevent breakage and accidental release; keep away from food, water supplies
Environmental Hazards: Not classified as marine pollutant
U.S. Regulations: TSCA inventory status: Not listed (drug substance); SARA Title III: Not reportable
European Union: Classified under Regulation (EC) No 1272/2008 as pharmaceutical intermediate
Global Listings: Registered as active pharmaceutical ingredient as per regional pharmaceutical regulations; not subject to standard chemical hazard communication;
Label Requirements: GHS and local workplace labeling with hazard statements as above
Other Regulations: No Ozone Depleting Substance; not listed under Persistent Organic Pollutants, not restricted under export control
