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Product Name: Tofacitinib Citrate
Chemical Name: Tofacitinib 2-hydroxy-1,2,3-propanetricarboxylate (1:1)
Synonyms: CP 690550-10; Xeljanz
CAS Number: 540737-29-9 (Tofacitinib), 6138-23-4 (Citrate component)
Intended Use: Research, pharmaceutical intermediate
Supplier Identification: Contact details required for emergencies; reference local or institutional contact
Emergency Telephone: Poison control center, or workplace's chemical safety unit
Recommended Use Restrictions: Use according to pharma safety guidelines
GHS Classification: Harmful if swallowed; May cause skin or eye irritation; Reproductive toxicity suspected; Target organ toxicity possible upon repeated exposure
Label Elements: Signal word: Warning; Hazard pictograms: Exclamation mark, health hazard symbol
Hazard Statements: Causes moderate eye irritation; May be harmful if inhaled or absorbed through skin; Long-term exposure may affect immune function
Precautionary Statements: Avoid contact with skin, eyes, and clothing; Practice good industrial hygiene and safety; Only trained personnel should handle
Other Hazards: Limited data available for environmental toxicity; Product dust can irritate airways
Chemical Identity: Tofacitinib Citrate
Concentration: >98% purity for pharmaceutical grade
Molecular Formula: C16H20N6O•C6H8O7
Molecular Weight: 504.49 g/mol
Relevant Impurities: Trace organic solvents or synthesis-related micro-impurities <0.5%
Inhalation: Move exposed individual outdoors. Seek medical attention if symptoms (cough, shortness of breath) persist. Support breathing as needed.
Skin Contact: Remove contaminated clothing. Wash affected area thoroughly with soap and water. Get medical attention if irritation develops.
Eye Contact: Rinse eyes under running water for at least 15 minutes. Remove contact lenses if present. Go to medical facility if symptoms continue.
Ingestion: Rinse mouth, but do not induce vomiting unless instructed by medical personnel. Drink water if alert. Obtain medical care without delay.
Most Important Symptoms: Redness or irritation; respiratory tract effects with prolonged exposure
Advice for Emergency Responders: Gloves, eye protection, and protective clothing recommended
Suitable Extinguishing Media: Carbon dioxide (CO2), dry powder, or foam. Use water spray for cooling exposed containers.
Hazards from Combustion: Emits toxic fumes including nitrogen oxides, carbon monoxide, carbon dioxide; hydrogen cyanide possible in incomplete combustion
Protective Equipment: Full body fire-resistant suit and breathing apparatus
Specific Firefighting Procedures: Prevent run-off from entering drains or waterways; stay upwind of smoke
Personal Precautions: Use appropriate PPE—gloves, eye protection, lab coat. Avoid dust formation and inhalation.
Environmental Precautions: Keep product from entering drains, watercourses, or soil.
Methods for Cleanup: Collect spill using damp absorbent material to minimize airborne dust. Properly ventilate area. Dispose of collected material in accordance with regulations.
Reference to Other Sections: See exposure controls and disposal considerations for further guidance
Handling: Wear proper lab attire—gloves, goggles, closed footwear. Minimize dust and avoid ingestion, inhalation, or skin contact. Wash hands before breaks and after work.
Storage: Store under cool, dry conditions with good ventilation. Keep container tightly sealed. Protect from light and incompatible materials like strong oxidizers.
Incompatibilities: Avoid contact with acids and strong bases; separate from foodstuffs and drinkables
Special Requirements: Restrict access to trained personnel. Keep away from uncontrolled heat sources
Control Parameters: No occupational exposure limits established; use general dust limits as guideline.
Engineering Controls: Lab fume hood or local exhaust recommended; keep airborne concentration below nuisance limits.
Eye/Face Protection: Safety goggles or face shield
Skin Protection: Lab gloves (nitrile or similar resistant material); lab coat
Respiratory Protection: Approved respirator for handling powder or dust; avoid breathing dust
Hygiene Measures: No eating, drinking, or smoking in designated work areas; wash thoroughly after exposure
Appearance: White to off-white powder
Odor: Odorless or faint chemical smell
Odor Threshold: Not established
pH (solution): Not determined for solid; acidic in aqueous solution
Melting Point: Noted above 199°C;
Boiling Point: Decomposes before boiling
Flash Point: Data not available for pharmaceutical intermediate
Evaporation Rate: Not applicable (solid)
Vapor Pressure: Negligible at room temperature
Solubility: Soluble in DMSO, slightly soluble in water, methanol
Density: Approximately 1.4–1.5 g/cm3
Partition Coefficient: LogP data supports moderate solubility in organic solvents
Decomposition Temperature: Over 250°C
Viscosity: Not applicable
Reactivity: Stable under recommended handling and storage conditions
Chemical Stability: Stable at ambient temperature, sensitive to strong oxidizers
Hazardous Reactions: Nonexplosive; avoid mixing with peroxides or acids
Incompatible Materials: Acids, bases, oxidizers; water-sensitive at higher temperatures
Decomposition Products: Carbon oxides, nitrogen oxides, toxic fumes upon combustion
Polymerization: Not anticipated under normal conditions
Acute Toxicity: Harmful if swallowed; extrapolated LD50 (oral, rat)<1,000 mg/kg
Skin Corrosion/Irritation: May cause mild skin irritation with direct contact
Eye Damage/Irritation: Possible eye irritant
Respiratory Sensitizer: Not classified but dust can irritate mucous membranes
Carcinogenicity: No IARC or NTP classification; long-term risk not ruled out
Reproductive Toxicity: Animal studies indicate risk; treat as potential reproductive hazard
Additional Data: Immunosuppression possible on repeated exposure; seek medical advice following significant contact
Aquatic Toxicity: No official limit data, but expected toxicity to aquatic organisms at low concentrations; precaution recommended
Persistence: Not readily biodegradable; persistent in some environments
Bioaccumulation: Cannot be excluded based on drug structure
Mobility in Soil: Likely low mobility due to molecule size and partial water solubility
Other Adverse Effects: Effect on sewage bacteria possible; avoid environmental contamination
Product Disposal: Burn in a chemical incinerator equipped with afterburner and scrubber; consult licensed waste disposal service
Contaminated Packaging: Dispose of unused containers under same conditions as product; triple rinse and render unusable
Sewage Disposal: Prevent release to water systems; never dispose via drains
Waste Code: Not assigned but treat as regulated laboratory waste
UN Number: Not classified as hazardous for transport under ADR, IATA, IMDG
Transport Name: Not regulated for air, land, or sea transport
Packing Group: Not assigned
Precautions: Ship in tightly sealed packaging; avoid mechanical stress or direct sunlight when transporting
Environmental Hazards: Transport in compliance with environmental protection guidelines to avoid accidental spillage
Safety: Subject to pharmaceutical regulatory controls under regional legislation
TSCA Status: Not listed for commercial manufacture in the United States
WHMIS: Controlled product (Canada), subject to workplace hazard communication
GHS Compliance: Meets hazard communication standards as per GHS
Labelling: Ensure containers display hazard pictogram, signal word, relevant precautionary and hazard statements
