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Material Safety Data Sheet (MSDS) for Parecoxib

Identification

Product Name: Parecoxib Sodium
Chemical Formula: C19H17N2NaO4S
CAS Number: 198470-85-8
Synonyms: Dynastat, N-(6-methoxy-2-pyridinyl)-5-methyl-3-phenyl-1H-pyrazole-1-acetate sodium salt
Recommended Uses: Selective COX-2 inhibitor for hospital use, mainly parenteral administration
Supplier Details: Sourced by major pharmaceuticals manufacturers; supplier contact should be listed directly on commercial MSDS
Emergency Contact: Facility-specific emergency number required

Hazard Identification

GHS Classification: Acute toxicity (oral, inhalation, dermal), Skin sensitization, Eye irritation
Signal Word: Warning
Hazard Statements: May be harmful if swallowed; may cause an allergic skin reaction; may cause eye irritation
Pictograms: Exclamation mark symbol
Precautionary Statements: Avoid breathing dust; wash skin thoroughly after handling; wear protective gloves; use eye protection
Routes of Entry: Inhalation, ingestion, skin and eye contact
Target Organs: Liver, kidneys, possible cardiovascular effects

Composition / Information on Ingredients

Parecoxib Sodium: 98-100%
Other Ingredients: Trace amounts of residual solvents and water (specifics provided by manufacturer)
Impurities: Not expected to exceed 0.1% for individual traces; results from select syntheses possible
Form: White to off-white crystalline powder, odorless
Molecular Weight: 387.41 g/mol

First Aid Measures

After Inhalation: Remove to fresh air and keep at rest; seek medical attention for persistent symptoms
After Skin Contact: Wash with soap and water; remove contaminated clothing
After Eye Contact: Rinse cautiously with water for several minutes; remove contact lenses if present and easy
After Ingestion: Rinse mouth; give water if conscious, do not induce vomiting; seek medical advice
Most Important Acute and Delayed Symptoms: Eye and skin irritation, allergy, gastrointestinal disturbance, headache
Notes to Physician: Treat symptomatically; provide supportive care

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, foam, dry powder, carbon dioxide
Unsuitable Extinguishing Media: Strong water jet unless necessary for cooling containers
Hazards from Combustion: Emits toxic smoke including carbon monoxide, nitrogen oxides, sulfur oxides
Protective Equipment: Full firefighting gear with self-contained breathing apparatus
Special Procedures: Prevent runoff, avoid inhaling smoke, use remote means if safe

Accidental Release Measures

Personal Precautions: Use personal protective equipment; avoid formation of dust; ventilate area
Environmental Precautions: Prevent entry into soil, sewers, and waterways; contain spills
Cleanup Methods: Pick up mechanically, place in proper waste containers; wash area with water after collection
Disposal: Dispose of according to local, regional, and national regulations
Decontamination: Avoid dry sweeping; use damp methods or HEPA-filter vacuums to minimize airborne powder

Handling and Storage

Handling: Avoid contact with eyes, skin, and clothing; avoid inhaling dust; use proper protective equipment; keep containers tightly closed
Storage: Store in original containers, tightly sealed, at controlled room temperatures; keep away from moisture, heat, direct sunlight, incompatible substances
Storage Conditions: Cool, dry, well-ventilated area
Handling Advice: Use fume hood or local exhaust during weighing or transfer
Incompatible Materials: Strong oxidizers, acids, bases

Exposure Controls and Personal Protection

Exposure Limits: Manufacturer or regulatory body has not assigned specific occupational exposure limits
Engineering Controls: Local exhaust ventilation at processing areas; containment if possible
Personal Protective Equipment (PPE): Nitrile or latex gloves, protective goggles, lab coat, dust mask or NIOSH-approved respirator
Hygiene Measures: Avoid eating, drinking, smoking while handling; wash hands thoroughly after use
Environmental Control: Maintain clean work environment; manage waste appropriately

Physical and Chemical Properties

Appearance: White or almost white crystalline powder
Odor: Odorless
pH: 7-9 (as aqueous solution)
Melting Point/Range: Not less than 220°C (decomposition)
Boiling Point: Not applicable (decomposes)
Flash Point: Not flammable in standard conditions
Solubility: Soluble in water, slightly soluble in methanol
Partition Coefficient (log Kow): Estimated ~2.2-2.5
Vapor Pressure: Negligible at ambient temperature
Relative Density: ~1.45 g/cm³
Viscosity: Not applicable

Stability and Reactivity

Chemical Stability: Stable under recommended storage and handling conditions
Reactivity: Not reactive under normal use
Possible Hazardous Reactions: Can react vigorously with strong oxidizers
Decomposition Products: Carbon oxides, nitrogen oxides, sulfur oxides
Conditions to Avoid: Excessive heat, moisture, incompatibles
Polymerization: Not expected under normal conditions

Toxicological Information

Acute Toxicity: Oral LD50 (rat) > 2000 mg/kg
Skin Corrosion/Irritation: May cause mild to moderate irritation, especially with prolonged exposure
Eye Damage/Irritation: May cause temporary redness or discomfort
Respiratory Sensitization: Dust may irritate mucous membranes
Skin Sensitization: Mild risk of allergic reaction in sensitive persons
Carcinogenicity: No evidence in animal tests
Mutagenicity: No evidence in Ames or other bacterial mutation assays
Reproductive Toxicity: Effects in animal studies at high exposures include fetal toxicity
Repeated Dose Toxicity: Evidence of reversible gastrointestinal, hepatic, renal impacts after long-term dosing (animal studies)

Ecological Information

Ecotoxicity: Chronic aquatic toxicity possible; data indicate moderate to low toxicity to aquatic organisms
Persistence and Degradability: Poorly biodegradable in water; may persist under environmental conditions
Bioaccumulation Potential: Log Kow suggests some bioaccumulation possible, but data lacking
Mobility in Soil: Low to moderate based on water solubility and partition coefficient
Other Adverse Effects: Active pharmaceutical may impact aquatic life if released in significant concentrations

Disposal Considerations

Product Disposal: Incinerate or dispose as hazardous pharmaceutical waste under regional regulations
Container Disposal: Rinse containers thoroughly, then dispose as chemical waste
Environmental Hazards: Do not release to surface water, drains, or natural environment
Waste Transport: Use authorized chemical waste contractor; document all transport and disposal steps according to site policy

Transport Information

UN Number: Not regulated for transport under UN, ADR, IATA, IMDG (check with supplier for latest regional updates)
Shipping Name: Not classified as dangerous cargo
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Special Precautions: Avoid damage to packaging; keep dry during transit; transport in secure, clearly labeled containers

Regulatory Information

Labelling: Complies with OSHA, WHMIS, GHS for workplace chemicals
Inventory Status: Listed or exempted in national inventories for pharmaceuticals
REACH (EU): Exempt as medicinal product
SARA Title III (US): Not listed as extremely hazardous
California Proposition 65: Not listed
Other National Regulations: Subject to health, safety, and environmental controls in pharmaceutical production and clinical use
Worker Protection: Training and hazard communication should follow national occupational safety guidelines