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MSDS of Mycophenolate Mofetil

Identification

Product Name: Mycophenolate Mofetil
Synonyms: CellCept, RS-61443, MMF
Chemical Formula: C23H31NO7
CAS Number: 128794-94-5
Recommended Use: Immunosuppressive agent, laboratory research
Manufacturer Information: Available through various pharmaceutical companies
Emergency Contact: Refer to regional poison control and emergency numbers
Product Use Restrictions: Not for unauthorized personnel, avoid direct administration outside licensed medical settings

Hazard Identification

Physical State: Solid, crystalline powder
Health Hazards: Harmful if swallowed or inhaled, skin sensitizer, reproductive toxicity, risk of genetic defects
Hazard Classification: Toxic if ingested, may cause organ damage with prolonged use
Potential Symptoms: Headache, nausea, vomiting, diarrhea, mouth ulcers, leukopenia
GHS Pictograms: Health hazard, exclamation mark
Precautionary Statements: Avoid contact with skin and eyes, do not breathe dust, wash hands after handling, use only in well-ventilated area
Signal Word: Danger

Composition / Information on Ingredients

Active Ingredient: Mycophenolate Mofetil
Chemical Purity: More than 98% in pharmaceutical grade
Other Ingredients: None for pure bulk substance
Impurities: Trace levels of process-related chemical residues possible, consult certificate of analysis for isolable content
Concentration: 100% when supplied as reagent or API

First Aid Measures

Inhalation: Remove person to fresh air immediately, keep comfortable for breathing, seek medical attention if symptoms appear
Skin Contact: Remove contaminated clothing, rinse skin thoroughly with water, seek medical help for irritation or rash
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present, continue rinsing, consult physician
Ingestion: Rinse mouth, do not induce vomiting, provide water if the individual is conscious, get immediate medical assistance
Most Important Symptoms: Gastrointestinal discomfort, immunosuppression, increased risk of infection
Advice for Medical Personnel: Symptomatic and supportive treatment favored, monitor blood counts and immune function

Fire-Fighting Measures

Suitable Extinguishing Media: Use alcohol-resistant foam, dry chemical powder, carbon dioxide, or water spray
Specific Hazards: Fire may release toxic fumes including nitrogen oxides, carbon monoxide, carbon dioxide
Protective Equipment: Self-contained breathing apparatus and full protective gear recommended
Hazardous Combustion Products: Irritant gases and vapors may form under fire conditions
Advice for Firefighters: Prevent runoff from entering drains, use caution when approaching fire zone

Accidental Release Measures

Personal Precautions: Evacuate area, use approved respirator, prevent dust formation, avoid breathing vapors
Environmental Precautions: Prevent contamination of soil, waterways, and drains, contain spill to smallest area possible
Clean-Up Methods: Scoop up and collect spilled material using a dust-free method, place in sealed container for proper disposal, wash area with detergent and water
Disposal of Contaminated Materials: Dispose of cleaning materials and absorbents as hazardous waste
Notifications: Comply with local, regional, and national reporting requirements

Handling and Storage

Handling: Maintain strict hygiene, avoid inhalation of dust and contact with skin or eyes, always wear suitable personal protective equipment in production or laboratory settings
Storage Conditions: Store in tightly closed container, away from incompatible substances like strong oxidizers or acids, keep in a secure, cool, dry, and well-ventilated area that is protected from light
Special Provisions: Keep away from food and beverages, restrict access to trained personnel only
Sensitive to Light: Decompose if exposed to direct sunlight for prolonged periods
Incompatibilities: Strong acids, bases, oxidizing agents

Exposure Controls and Personal Protection

Engineering Controls: Use chemical fume hood with laminar airflow, exhaust systems to minimize dust
Eye Protection: Safety goggles or face shield
Skin Protection: Lab coat, gloves made of nitrile or other chemical-resistant material, coveralls for bulk handling
Respiratory Protection: Approved respirator if airborne exposure above control limits or during spills
Work Hygiene: Remove contaminated clothing before entering eating areas, keep work area clean, do not eat, drink or smoke while handling
Occupational Exposure Limits: Specific limits may vary by region, but recommended to keep as low as reasonably achievable

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH: 4.5 - 6.5 (soluble in water)
Melting Point: 94-98°C
Boiling Point: Decomposes before boiling
Flash Point: Not flammable
Evaporation Rate: Not applicable
Solubility: Slightly soluble in water, soluble in ethanol, methanol, DMSO
Vapor Pressure: Not relevant at room temperature
Partition Coefficient (n-octanol/water): 3.6
Viscosity: Not applicable
Decomposition Temperature: Above 100°C
Auto-Ignition Temperature: Not self-igniting

Stability and Reactivity

Chemical Stability: Stable under recommended storage and handling conditions
Reactivity: No unusual reactivity, though may react with strong oxidizers and acids
Incompatible Materials: Avoid exposure to strong acids, bases, and oxidizing agents
Conditions to Avoid: Prolonged exposure to heat, moisture, and light
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides upon burning
Polymerization: Does not polymerize

Toxicological Information

Routes of Exposure: Inhalation, skin contact, ingestion, eye contact
Acute Toxicity: LD50 (oral, rat): about 4000 mg/kg
Skin and Eye Irritation: May cause irritation upon direct contact
Respiratory Sensitization: Irritating to mucous membranes and respiratory tract with extended exposure
Chronic Toxicity: Risk of bone marrow suppression, immune system impact, increased risk of infections and lymphoma
Carcinogenicity: Not classified as carcinogenic by IARC, NTP or OSHA
Reproductive Toxicity: Associations with congenital malformations, teratogenic effects in exposed pregnant women according to evidence from clinical and animal research
Mutagenicity: Some positive findings in laboratory mutagenicity assays
Target Organs: Bone marrow, gastrointestinal tract, immune system

Ecological Information

Ecotoxicity: Harmful to aquatic organisms at high concentrations, avoid environmental release
Aquatic Toxicity: LC50/EC50 values not fully established but may affect growth or survival of aquatic microorganisms
Persistence and Degradability: Poorly biodegradable, can persist in the environment
Bioaccumulative Potential: Possible moderate bioaccumulation, not well-studied
Mobility in Soil: Moderate mobility based on water solubility and partition coefficient
Other Adverse Effects: Limited large-scale environmental impact data, caution warranted for disposal

Disposal Considerations

Waste Treatment Methods: Incinerate at an approved hazardous waste facility or follow regional pharmaceutical waste procedures
Packaging Disposal: Decontaminate containers before recycling or use as hazardous chemical waste
Sewage Disposal: Avoid discharge into wastewater systems to prevent impact on water treatment plants
Special Precautions: Wear protective equipment during disposal procedures, follow local environmental control guidelines
Disposal Containers: Use sealed, labeled, chemically resistant containers

Transport Information

UN Number: Not assigned for non-bulk, research use
Transport Hazard Class: Not regulated as dangerous goods for most forms, confirm with local requirements
Packing Group: No specific assignment
Proper Shipping Name: Mycophenolate Mofetil
Environmental Hazards: Avoid release to environment during shipment
Special Precautions: Prevent breakage or spillage in transit, keep containers closed and protected from physical damage, comply with all relevant regulations
Transport Labels: Not required outside of large bulk shipments, apply hazardous substance labeling where demanded

Regulatory Information

OSHA Status: Not classified as hazardous under OSHA criteria, yet precautions strongly advised in workplace
TSCA (US): Not listed for commercial use, research status may apply
EU REACH Status: Exempt from registration due to pharmaceutical use
WHMIS (Canada): Not classified, use best-practice occupational health measures
SARA Title III: Not listed under Section 313
California Prop 65: Not listed, but observe reproductive hazard precautions
Other International Regulations: Subject to prescription-only and controlled distribution in most countries
Label Requirements: Toxic, handle with care, restricted to professional use
Product Registration: Approved for human use by regulatory authorities (FDA, EMA) for specified disease settings