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Material Safety Data Sheet: Ketoprofen

Identification

Product Name: Ketoprofen
Chemical Name: 2-(3-benzoylphenyl)propionic acid
Synonyms: Orudis, Oruvail, Ketona, Keral
CAS Number: 22071-15-4
Recommended Use: Pharmaceutical product, Non-steroidal anti-inflammatory drug (NSAID)
Supplier: Manufacturer and distributor information can be found on the product label.
Emergency Phone Number: Provided by supplier or local poison control center

Hazard Identification

GHS Classification: Acute Toxicity (Oral Category 4), Eye Irritation (Category 2A), Skin Sensitization (Category 1)
Signal Word: Warning
Hazard Statements: Harmful if swallowed, causes serious eye irritation, may cause an allergic skin reaction
Symbol(s): Exclamation mark
Precautionary Statements: Avoid breathing dust and handling without gloves, wash hands thoroughly after handling, wear protective eye protection
Other Hazards: May aggravate asthma or skin disorders in sensitive persons
Routes of exposure: Inhalation, ingestion, skin, eye

Composition / Information on Ingredients

Chemical Name: Ketoprofen
CAS Number: 22071-15-4
Concentration: 99% (pharmaceutical grade)
Impurities: Trace amounts of synthesis byproducts, all below 1%
Additives: None in bulk powder
Formulation Additives (for tablets/capsules): Lactose, cellulose, magnesium stearate, coloring agents (see tablet package insert)

First Aid Measures

Inhalation: Remove person to fresh air, keep comfortable for breathing, seek medical attention if symptoms persist
Skin Contact: Remove contaminated clothing, wash skin with soap and water, call medical help if irritation or redness appears
Eye Contact: Rinse gently with water for several minutes, remove contact lenses if possible, get medical attention for continuing symptoms
Ingestion: Rinse mouth with water, seek immediate medical help, bring product label or MSDS to the doctor
Most Important Symptoms: Irritated eyes, skin rash, upset stomach, headache
Acute Effects: Nausea, vomiting, abdominal pain
Delayed Effects: Allergic reactions, asthma exacerbation
Note for Medical Personnel: Treat symptomatically, support respiratory and cardiovascular function

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Unsuitable Extinguishing Media: Avoid using water jets on powder fires to prevent spread
Specific Hazards: Combustion releases toxic fumes, including carbon monoxide, carbon dioxide, nitrogen oxides
Firefighter Protection: Wear self-contained breathing apparatus, chemical-resistant clothing
Fire/Explosion Sensitivity: Not easily ignited, dust can form explosive mixtures with air
Other Precautions: Move containers from fire area if possible, prevent runoff from entering waterways

Accidental Release Measures

Personal Precautions: Use personal protective equipment, avoid inhaling dust, provide adequate ventilation
Environmental Precautions: Prevent product from entering drains, surface water, and soil
Small Spill Methods: Scoop up powder without generating dust, wipe area with damp cloth, dispose of waste as hazardous material
Large Spill Methods: Evacuate area, use HEPA vacuum or wet sweeping, collect in labeled containers for waste disposal
Cleaning Tools: Use non-sparking tools, avoid dry sweeping
Disposal: Follow local hazardous waste rules, do not flush into sewer

Handling and Storage

Safe Handling Practices: Use in well-ventilated area, avoid contact with eyes and skin, do not inhale dust
Hygiene Recommendations: Wash hands after handling, remove contaminated clothing immediately
Storage Requirements: Store in tight, clearly labeled containers, keep away from moisture, light, and heat sources
Incompatible Materials: Strong acids, strong bases, oxidizing agents
Temperature Recommendations: Room temperature (15–25°C), avoid refrigeration near food or beverage storage
Special Storage Requirements: Store with other pharmaceuticals, away from incompatible chemicals

Exposure Controls and Personal Protection

Occupational Exposure Limit: None established for Ketoprofen (consult country or state regulations for pharmaceutical dust)
Engineering Controls: Local exhaust ventilation, enclosed systems for manufacturing, minimize dust generation
Personal Protective Equipment: Gloves (nitrile recommended), chemical splash goggles, lab coats or protective coveralls
Respiratory Protection: NIOSH-approved dust mask if airborne dust exceeds recommended levels
Environmental Controls: Prevent medication residues from entering water bodies or soil

Physical and Chemical Properties

Appearance: White or off-white crystalline powder
Odor: Odorless or faint phenolic scent
pH: Slightly acidic (solution in water)
Melting Point: 94–97°C
Boiling Point: Decomposes before boiling
Solubility: Sparingly soluble in water, soluble in ethanol and acetone
Vapor Pressure: Negligible at room temperature
Partition Coefficient (log Kow): 0.97
Density: Approximately 1.2 g/cm³
Flash Point: No data available
Autoignition Temperature: Not established
Molecular Formula: C16H14O3
Molecular Weight: 254.28 g/mol

Stability and Reactivity

Chemical Stability: Stable under normal handling and storage conditions
Hazardous Polymerization: Does not occur
Reactivity: Reacts with strong acids, bases, and oxidizers causing possible degradation or hazardous gas release
Conditions to Avoid: Exposure to strong heat, humidity, direct sunlight, open flames
Decomposition Products: Carbon oxides, nitrogen oxides, potentially irritating organic vapors

Toxicological Information

Acute Toxicity (Oral, Rat): LD50 ≈ 360 mg/kg
Acute Toxicity (Dermal): No data in animals; effects expected at high exposure
Inhalation Toxicity: Not expected at typical workplace levels, dust may cause airway irritation
Skin Irritation: May cause redness or rash after direct contact
Eye Irritation: Causes stinging, redness, watering
Sensitization: Documented allergic reactions in sensitive individuals
Chronic Toxicity: Long term high-dose use may cause gastrointestinal ulcers, kidney injury
Carcinogenicity: Not listed by IARC, NTP, or OSHA
Mutagenicity: No evidence in current studies
Reproductive Toxicity: Harmful to fetus in animal studies, avoid in pregnancy unless essential
Other Health Effects: May worsen skin or respiratory allergies if already present

Ecological Information

Aquatic Toxicity: Harmful to aquatic organisms at high concentrations (EC50 for daphnia ≈ 50 mg/L)
Persistence: Not readily degradable in aquatic environments, can persist for weeks
Bioaccumulation: Low bioaccumulation potential based on logKow
Mobility in Soil: Moderate mobility due to low water solubility
Other Effects: Adverse impact possible on aquatic life if disposed in large amounts, no significant effect from small-scale release

Disposal Considerations

Waste Disposal: Treat as hazardous pharmaceutical waste, incineration recommended at licensed facility
Contaminated Packaging: Rinse containers, dispose as chemical waste
Environmental Hazards: Avoid disposal via drains, sinks, landfill without treatment
Local Regulations: Comply with local, regional, or national hazardous waste disposal rules

Transport Information

UN Number: Not regulated under ADR/RID/IMDG/IATA
Proper Shipping Name: Not classified as dangerous for transport
Hazard Class: Not applicable
Packing Group: Not applicable
Special Precautions: Use secure packaging to prevent release, transport with other pharmaceuticals only
Environmental Hazards: Not a marine pollutant

Regulatory Information

US TSCA: Not listed, pharmaceutical use only
EU Regulations: Listed as an active pharmaceutical ingredient under ECHA
OSHA Hazard Communication: Requires hazard labeling in workplaces
SARA/Title III: Not a listed hazardous substance
Canada DSL/NDSL: Not listed
Labelling Requirements: Compliant with local country pharmaceutical labeling, GHS classification as needed
Other Regulations: Subject to controlled substance laws in some jurisdictions for prescription use