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Piroxicam Material Safety Data Sheet (MSDS) Information

Identification

Product Name: Piroxicam
Chemical Name: 4-hydroxy-2-methyl-N-(pyridin-2-yl)-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide
Synonyms: Brexin, Feldene
CAS Number: 36322-90-4
Molecular Formula: C15H13N3O4S
Molecular Weight: 331.35 g/mol
Recommended Use: Non-steroidal anti-inflammatory drug for pain and inflammation relief
Supplier Contact Information: Requests for supplier’s full address and emergency phone number are standard workplace safety procedures.

Hazard Identification

GHS Classification: Acute toxicity (Oral and Inhalation), Skin sensitization, Eye irritation, Reproductive toxicity, Specific target organ toxicity
Hazard Statements: May cause skin and eye irritation. Can cause allergic skin reaction. May be harmful if swallowed or inhaled. Can cause serious health issues with repeated exposure.
Precautionary Statements: Avoid contact with eyes, skin, and clothing. Do not breathe dust or fumes. Use only with adequate ventilation. Wear recommended protective equipment. Wash hands thoroughly after handling.
Signal Word: Warning

Composition / Information on Ingredients

Ingredient: Piroxicam
Concentration: 100% (pure substance) or as specified on pharmaceutical formulations
Impurities/Additives: Not usually present in significant quantity in bulk raw ingredient form. Tablet formulations could include excipients like lactose, corn starch, magnesium stearate.

First Aid Measures

Eye Contact: Flush eyes thoroughly with plenty of water for at least 15 minutes. Remove contact lenses if present and easy to do. Seek medical advice immediately if irritation develops or persists.
Skin Contact: Remove contaminated clothing and wash skin with soap and water. Get medical attention if rash, irritation, or allergic reaction occurs.
Inhalation: Move affected person to fresh air. Provide oxygen or artificial respiration if needed. Seek medical help if symptoms like coughing or shortness of breath occur.
Ingestion: Rinse mouth with water. Do not induce vomiting unless directed by medical personnel. Call a poison center or doctor immediately.

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide.
Specific Hazards: Powder may form explosive mixtures with air. Burning releases toxic fumes of nitrogen oxides, sulfur oxides, and carbon monoxide.
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and full protective gear to avoid exposure to combustion products.
Special Procedures: Isolate fire area and stay upwind. Evacuate area, keep containers cool with water spray.

Accidental Release Measures

Personal Precautions: Use proper personal protection including gloves, mask, and goggles. Avoid breathing dust. Ventilate the area well.
Environmental Precautions: Prevent entry into drains, sewers, or waterways. Notify authorities if a large spill enters the environment.
Cleanup Methods: Sweep up bulk material without creating dust. Collect in labeled, closed containers for disposal. Wash spill area with water after removal.
Decontamination: Wear suitable protection and avoid direct contact with skin or mucous membranes during cleaning.

Handling and Storage

Handling: Store in a tightly closed, clearly labeled container in a cool, dry, and well-ventilated space. Handle with local exhaust ventilation. Use tools and equipment that do not generate sparks or static discharge. Avoid formation of dust. Do not eat, drink, or smoke during handling. Practice good workplace hygiene.
Storage: Keep away from incompatible materials like strong oxidizers and acids. Store away from heat or flame sources. Prevent unauthorized access to storage areas. Periodically inspect storage containers for leaks or signs of damage.

Exposure Controls and Personal Protection

Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. Keep workplace free from dust accumulation.
Personal Protection: Wear gloves (nitrile, neoprene), protective safety glasses or goggles, and a lab coat or apron. Use a NIOSH/MSHA approved respirator if exposure to dust is likely. Eye-wash fountain and emergency showers should be available near work area.
Exposure Limits: No specific occupational exposure limit values for Piroxicam. As a general rule for pharmaceutical actives, occupational exposure banding or internal guidelines may apply.

Physical and Chemical Properties

Appearance: Yellowish crystalline powder
Odor: Odorless or faint characteristic smell
Odor Threshold: Not applicable
pH: Slightly acidic in water suspension
Melting Point: 198–200 °C
Boiling Point: Decomposes before boiling
Flash Point: Not detected
Evaporation Rate: Not applicable
Flammability: Not highly flammable, but fine dust may combust in air
Vapor Pressure: Negligible
Solubility: Poorly soluble in water, freely soluble in alcohol, chloroform
Partition Coefficient (log Kow): 2.23
Density: Approximately 1.5 g/cm³

Stability and Reactivity

Chemical Stability: Stable at room temperature in closed containers and dry conditions. Moisture may cause slow degradation.
Hazardous Reactions: No dangerous reactions expected under normal conditions of use.
Incompatible Materials: Strong oxidizing agents, acids, bases can degrade the compound.
Decomposition Products: Hazardous decomposition may release nitrogen oxides, sulfur oxides, carbon monoxide, and carbon dioxide at high temperatures or during combustion.

Toxicological Information

Acute Toxicity: Reported oral LD50 (rat): 950 mg/kg. May cause nausea, stomach pain, headache, dizziness, or drowsiness at high doses.
Chronic Toxicity: Prolonged overexposure may affect kidney, liver, and gastrointestinal tract. Can cause ulcers or bleeding with long-term exposure.
Sensitization: Allergic skin reactions possible
Carcinogenicity: Not classified as human carcinogen by IARC, NTP or OSHA
Mutagenicity: No strong evidence of mutagenicity in standard tests
Reproductive Effects: May affect fertility or fetal development with prolonged or high exposure levels in research animals.
Symptoms of Overexposure: Stomach pain, vomiting, diarrhea, headache, allergic reactions.

Ecological Information

Ecotoxicity: May be harmful to aquatic life if large quantities enter streams, rivers, or groundwater due to persistence and bioaccumulation potential.
Persistence and Degradability: Not easily biodegradable in soil or water; can persist for weeks or months.
Bioaccumulative Potential: Moderate bioaccumulation; potential for food chain buildup.
Mobility in Soil: Low mobility due to low water solubility.
Other Adverse Effects: Avoid release to the environment as a best practice for pharmaceutical substances.

Disposal Considerations

Disposal Methods: Collect in suitable containers, label for hazardous chemical waste. Dispose of through licensed chemical disposal contractor. Do not flush down drains, sewers, or allow to contaminate water sources.
Contaminated Packaging: Treat as hazardous waste and dispose of according to local, state, and federal regulations. Decontaminate containers if possible before recycling or disposal.
Local/Regional Regulations: Most jurisdictions require pharmaceutical actives to be disposed in controlled facilities.

Transport Information

UN Number: Not regulated for ground or air transport under standard chemical procedures.
Proper Shipping Name: Piroxicam
Transport Hazard Class: Not classified as hazardous for transport
Packing Group: Not applicable
Marine Pollutant: Not listed as marine pollutant, but take care to avoid environmental releases.
Special Precautions: Protect from physical damage and moisture during transport. Secure containers during shipping to prevent leaks.

Regulatory Information

Safety, Health, Environmental Regulations: Listed under relevant pharmaceutical regulations and chemical inventories in most countries.
OSHA Status: Not specifically regulated as hazardous, but general chemical safety standards apply.
TSCA Status: Not listed individually for commercial use; intended for pharmaceutical applications.
EU REACH: Not specifically registered; regulated by the European Medicines Agency for pharmaceutical uses.
WHMIS Classification (Canada): Not classified under Canadian WHMIS, but workplace labeling and controls recommended.
Other: This substance falls under controls for APIs (active pharmaceutical ingredients) worldwide. Keep records of usage, disposal, and personnel exposure in compliance with Good Manufacturing Practices and occupational safety standards.