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Product Name: Loxoprofen Sodium
Chemical Formula: C15H17NaO3
Molecular Weight: 268.28 g/mol
CAS Number: 80382-23-6
Common Synonyms: Loxoprofen sodium hydrate, trans-2-(4-(2-oxocyclopentylmethyl)phenyl)propanoic acid sodium salt
Recommended Use: Pharmaceutical active ingredient, nonsteroidal anti-inflammatory drug (NSAID)
Manufacturer Contact Details: Name, address, website, emergency telephone as required by local regulations
GHS Classification: Acute toxicity (oral, category 4), eye irritation (category 2), specific target organ toxicity – repeated exposure (category 2)
Signal Word: Warning
Hazard Statements: Harmful if swallowed; causes serious eye irritation; may cause damage to organs through prolonged or repeated exposure
Pictograms: Exclamation mark, Health hazard
Precautionary Statements: Avoid breathing dust or powder; wash hands thoroughly after handling; do not eat, drink, or smoke when using this product; wear eye protection
Potential Health Effects: Eye, skin, and respiratory irritation; possible gastrointestinal disturbances if ingested; long term or repeated exposure may impact liver and renal function; medical conditions aggravated include peptic ulcers, asthma, renal impairment
Chemical Name: Loxoprofen Sodium
Concentration: 98-100% pure substance
Impurities: Trace residual solvents (methanol, ethanol, acetone below 0.1%), by-products under detection threshold
Other Ingredients: None in pure API; for formulated product, may include starch, silicon dioxide, lactose, magnesium stearate as excipients
Inhalation: Move to fresh air, keep at rest, monitor for respiratory symptoms; seek medical advice if irritation or symptoms persist
Skin Contact: Remove contaminated clothing, rinse skin with plenty of water and mild soap, consult a physician if irritation develops
Eye Contact: Rinse immediately with copious amounts of water for at least 15 minutes, hold eyelids apart; remove contact lenses if present; seek medical attention immediately
Ingestion: Rinse mouth, do not induce vomiting; give small amount of water unless unconscious; seek medical care
Most Important Symptoms: Nausea, vomiting, stomach pain, skin and eye irritation; rare cases of allergic skin reactions
Flammability: Not flammable under normal storage and handling
Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Unsuitable Extinguishing Media: High volume water jets
Specific Hazards: Decomposition may release carbon monoxide, carbon dioxide, nitrogen oxides, and sodium oxide fumes
Protective Equipment: Use self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes during firefighting
Key Precautions: Prevent fire-fighting runoff from entering drains or waterways; clear area of unnecessary personnel
Personal Precautions: Avoid dust formation; use adequate ventilation; wear protective gloves, goggles, and dust mask or respirator
Environmental Precautions: Prevent material from entering drains, surface water, groundwater, or soil
Methods for Containment and Cleaning: Sweep or vacuum up without generating dust; collect in labeled, closed containers for disposal in accordance with local regulations; mop area with damp cloth after removal
Notification Procedures: Report spills to supervisory personnel; follow company procedures for hazardous material release
Safe Handling: Minimize dust generation and accumulation; wash hands thoroughly after handling; avoid inhalation and direct contact; use in well-ventilated areas
Storage Conditions: Store in tightly sealed containers, away from incompatible substances such as oxidizing agents; keep in cool, dry, and well-ventilated area; protect from light, heat, and moisture
Special Requirements: Storage temperature recommended between 15–30°C; keep container tightly closed and correctly labeled; segregate from food and beverages
Exposure Limits: No established occupational exposure limits for loxoprofen sodium; handle as nuisance dust (ACGIH TLV for particulates not otherwise regulated: 10 mg/m3 total inhalable dust)
Engineering Controls: Use local exhaust ventilation or containment system to keep dust below recommended limits
Personal Protective Equipment (PPE): Wear chemical-resistant gloves (nitrile or PVC), safety goggles, lab coat, and, if dust levels are high, use a NIOSH-approved particulate respirator
Industrial Hygiene Practices: Remove and wash contaminated clothing after handling; do not eat, drink, or smoke in the work area; maintain good housekeeping to minimize contamination
Appearance: White to pale yellowish crystalline powder
Odor: Odorless or slight characteristic odor
pH (1% Solution): 8–10
Melting Point: Approximately 195–200°C (decomposes)
Boiling Point: Not available (decomposes before boiling)
Solubility: Freely soluble in water; soluble in methanol, ethanol, and slightly soluble in acetone or chloroform
Partition Coefficient (logP): 1.18 (octanol/water, as free acid)
Vapor Pressure: Not applicable (non-volatile solid under normal conditions)
Relative Density: 1.2–1.4 g/cm3
Flash Point: Not applicable
Flammability: Not flammable under ambient conditions
Auto-Ignition Temperature: Not determined
Chemical Stability: Stable under recommended storage and handling conditions
Possible Hazardous Reactions: Reacts with strong oxidizing agents producing toxic gases
Conditions to Avoid: Exposure to humidity, elevated temperatures, open flames, strong acids or oxidizers
Incompatible Materials: Strong acids, strong bases, oxidizing agents
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, sodium oxides on thermal decomposition
Acute Toxicity: Oral LD50 (rat) approximately 600 mg/kg; data based on public animal study literature
Skin Irritation: Slightly irritating based on single-dose testing
Eye Irritation: Causes moderate to severe irritation
Respiratory Sensitization: Dust may cause mild respiratory tract irritation
Chronic Toxicity: Prolonged or repeated exposure can affect kidneys and liver
Carcinogenicity: Not classified as a human carcinogen by IARC, NTP, OSHA
Reproductive Toxicity: Animal studies indicated possible developmental toxicity at high doses
Other Health Effects: Rare cases of allergic reactions, including rash and anaphylactoid symptoms
Routes of Exposure: Inhalation, ingestion, skin contact, eye contact
Symptoms: Nausea, headache, drowsiness, gastrointestinal distress, respiratory irritation, dermatitis in sensitive individuals
Ecotoxicity: Aquatic toxicity data limited; estimated aquatic toxicity to fish LC50 > 100 mg/L (low hazard)
Persistence and Degradability: Not rapidly biodegradable; may persist in aquatic and terrestrial environments
Bioaccumulative Potential: Low, based on log Kow and predicted bioaccumulation factor
Mobility in Soil: Moderately mobile; may leach from soil depending on local environmental conditions
Other Environmental Impacts: Pharmaceuticals detected in surface and wastewater suggest prudent disposal practices always improve outcomes; avoid release into environment
Waste Disposal Methods: Treat as hazardous pharmaceutical waste for large amounts; incinerate in an approved facility; comply with local, state, and federal regulations for disposal
Contaminated Packaging: Triple-rinse and offer for reconditioning; if not possible, dispose of as hazardous waste; do not reuse container
Environmental Precautions: Prevent from entering surface water, drains, or soil; follow national regulations for pharmaceutical disposal
Recommendations: Seek advice from licensed waste disposal companies or environmental authorities if in doubt
UN Number: Not regulated as dangerous goods under UN, IATA, IMDG, or DOT for ground, air, or sea transport
Proper Shipping Name: Loxoprofen sodium or pharmaceutical preparation, not otherwise specified
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Environmental Hazards: Not classified as a marine pollutant
Special Precautions: Keep containers sealed, dry, and protected from sunlight during transport; ensure compliance with applicable regional transport regulations
OSHA Status: Not specifically regulated as hazardous under OSHA Standard 29 CFR 1910
TSCA Status: Not listed on US TSCA Inventory as a finished pharmaceutical
SARA Title III: Not subject to reporting under SARA, CERCLA, or EPCRA
EU Classification: Not a dangerous substance according to EC criteria (67/548/EEC); CLP harmonized classification not established
Other Regulations: Subject to applicable pharmaceutical control laws including prescription drug regulations; Occupational exposure guidelines established by some countries for active pharmaceutical ingredient
Labeling Requirements: Conforms to local regulation for pharmaceutical substances, including correct hazard, precautionary, and product labeling for workplace and transport
