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Product Name: Dexketoprofen Trometamol
Synonyms: S(+)-Ketoprofen Trometamol Salt, 2-(3-benzoylphenyl)propionic acid, tromethamine salt
CAS Number: 156604-79-4
Manufacturer: Pharmaceutical supplier details, see packaging
Recommended Use: Pharmaceutical active ingredient, anti-inflammatory medication
Emergency Contact: Call local poison control center or manufacturer emergency number listed on the packaging
Classification: Irritant to eyes, skin, and respiratory system; possible sensitizer; harmful if swallowed in large amounts
Signal Word: Warning
Hazard Statements: Causes eye and skin irritation, may cause respiratory discomfort, may cause allergic skin reaction
Pictograms: Exclamation mark
Precautionary Statements: Avoid breathing dust or powder, wash thoroughly after handling, wear protective gloves, avoid contact with eyes and skin
Chemical Name: Dexketoprofen Trometamol
Chemical Formula: C16H14O3 · C4H11NO3
Component: Dexketoprofen Trometamol, pure or near pure as API
Impurities: Minimal, not expected to present a hazard within recommended handling practices
Inhalation: Move person to fresh air, support breathing as needed, seek medical attention for persistent irritation or if symptomatic
Skin Contact: Remove contaminated clothing, wash skin with plenty of soap and water, seek medical attention for persistent irritation
Eye Contact: Rinse immediately with water, lift eyelids to ensure thorough irrigation, seek medical attention if redness or pain continues
Ingestion: Seek medical attention right away, rinse mouth with water but do not induce vomiting unless directed by medical personnel
Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, or foam
Unsuitable Extinguishing Media: Do not use a water jet as it may spread the fire
Hazardous Combustion Products: Oxides of carbon, nitrogen oxides, irritating fumes and smoke
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective clothing
Fire Hazards: Powder may become airborne and form explosive mixtures with air in confined spaces
Personal Protection: Wear gloves, safety eyewear, dust mask or respirator if ventilation is poor
Containment: Stop further leakage or spillage if safe to do so
Cleanup Methods: Carefully sweep up to avoid dust generation, place in a suitable waste container, ventilate area, wash spill site with water after material pickup
Environmental Precautions: Prevent material from entering drains or watercourses
Protective Measures: Use only in well-ventilated areas, avoid generation of dust, avoid contact with eyes, skin, and clothing
Conditions for Safe Storage: Store container tightly closed in a dry, cool, well-ventilated place, protect from moisture and light
Incompatible Materials: Strong oxidizing agents, bases, acids
Hygiene Practices: Wash hands and face thoroughly after handling, do not eat, drink or smoke in work areas
Occupational Exposure Limits: Not established, keep dust generation low
Engineering Controls: Use local exhaust ventilation or process enclosure to keep airborne levels below recommended exposure limits
Personal Protective Equipment: Chemical-resistant gloves, safety goggles or face shield, laboratory coat or disposable coveralls, respiratory protection if dust is present
Environmental Controls: Avoid release to the environment, handle in accordance with best available practices to minimize environmental impact
Appearance: White or almost white crystalline powder
Odor: Slight or no odor
Odor Threshold: Not determined
pH Value: 9.0 to 10.0 (1% aqueous solution)
Melting Point: 150–160°C
Boiling Point: Decomposes
Solubility: Freely soluble in water and alcohol, almost insoluble in n-hexane
Flash Point: Not applicable
Relative Density: Approximately 1.3 g/cm3
Vapor Pressure: Not available
Partition Coefficient (Log P): 0.4–0.8 (estimated)
Chemical Stability: Stable under recommended storage conditions
Thermal Decomposition: May decompose if heated above melting point
Hazardous Reactions: No dangerous reactions are known under normal use and storage
Conditions to Avoid: Excessive heat, moisture, light exposure
Incompatible Materials: Strong oxidizing agents, acids, alkalis
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides
Acute Toxicity: Oral rat LD50 > 2000 mg/kg, low acute toxicity at recommended doses
Skin Contact: Mild local irritation possible in sensitive individuals
Eye Contact: May cause irritation, redness, tearing
Inhalation: May cause coughing, sneezing, respiratory tract irritation
Skin Sensitization: Can trigger allergic response
Repeated Dose Toxicity: Animal studies show effects on gastrointestinal tract, kidney, and liver at high doses
Carcinogenicity: Not classified as carcinogenic by IARC, ACGIH, NTP, or OSHA
Reproductive Toxicity: Like other NSAIDs, may interfere with pregnancy at high doses with long exposure
Ecotoxicity: Harmful to aquatic life with long lasting effects, avoid release into waterways
Persistence and Degradability: Expected to be relatively persistent in soil and water
Bioaccumulative Potential: Low potential based on structure
Mobility in Soil: Moderate mobility expected
Other Adverse Effects: Large releases can negatively impact microbial life in wastewater treatment facilities
Waste Treatment Methods: Dispose of as hazardous pharmaceutical waste, incineration in licensed facility preferred
Contaminated Packaging: Dispose of in accordance with local regulations
Precautions: Do not discharge into drains, surface water, or soil; do not mix with other waste streams
UN Number: Not classified as dangerous for transport (non-hazardous under transport regulations)
UN Proper Shipping Name: Not applicable
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Environmental Hazards: No transport-related environmental hazard expected
Special Precautions: Protect from physical damage and weather during transport, avoid exposure to heat or moisture
EU Regulations: Not classified as a dangerous substance under Regulation (EC) No. 1272/2008 (CLP)
US Regulations: Not listed under OSHA Hazard Communication Standard, TSCA status for research/medicinal use
WGK (Water Hazard Class, Germany): 2, hazardous to water
REACH Status: Exempt for pharmaceutical use
Other Regulations: Follow national and local occupational health and safety regulations for use, handling, storage, and disposal
