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Product Name: Nitazoxanide
Chemical Name: 2-(Acetyloxy)-N-(5-nitro-2-thiazolyl)benzamide
Synonyms: Alinia, NTZ
CAS Number: 55981-09-4
Recommended Uses: Antiprotozoal agent, antiparasitic medication
Manufacturer: Prescription pharmaceutical manufacturers and distributors
Emergency Contact: Local poison control or emergency services
Form: Powder or tablet, odorless, pale yellow
GHS Classification: Not classified as hazardous under GHS
Primary Hazards: Dust irritation to eyes, skin, and respiratory system, potentially harmful if swallowed in quantity
Pictogram: Not required under current labeling regulations
Signal Word: None
Precautionary Statements: Avoid inhalation and direct contact, wash after handling, minimize exposure to dust
Routes of Exposure: Inhalation, ingestion, skin, eyes
Potential Acute Effects: Irritation to mucous membranes, nausea or headache if ingested in large amounts
Chronic Effects: No carcinogenic, mutagenic, or reproductive risks identified in laboratory testing up to therapeutic dosage
Chemical Composition: Nitazoxanide (active pharmaceutical ingredient) - 100%
Chemical Formula: C12H9N3O5S
Impurities: Minor trace process impurities within pharmacopeia limits
Other Ingredients: None present in raw API
Concentration: Pharmaceutical grade, typically ranges from 90-100% nitazoxanide depending on formulation
Inhalation: Move person to fresh air, seek medical attention if symptoms develop such as cough or discomfort
Skin Contact: Remove contaminated clothing, rinse affected area thoroughly with soap and water, obtain medical advice for prolonged irritation
Eye Contact: Rinse cautiously with water for at least 15 minutes, remove contact lenses if present and easy to do, medical attention if irritation persists
Ingestion: Rinse mouth with water, do not induce vomiting, seek medical advice if large amounts have been ingested or symptoms develop
Note to Physician: Treat symptomatically and provide supportive care, no specific antidote identified
Suitable Extinguishing Media: Dry chemical powder, foam, carbon dioxide, water spray
Special Hazards: Combustion results in hazardous fumes such as oxides of carbon, nitrogen, and sulfur
Protective Equipment: Firefighters should use self-contained breathing apparatus and full protective clothing
Firefighting Advice: Move containers from fire area if safe, control runoff to prevent environmental contamination
Explosion Hazard: Dust formation may present minimal risk under industrial quantities; avoid dust accumulation
Personal Precautions: Avoid contact with skin and eyes, use protective gloves, goggles, and dust mask or respirator
Environmental Precautions: Prevent spread of material to surface water, soil, or drainage system
Methods for Clean-Up: Sweep or scoop up into suitable containers without creating dust, ventilate area, clean residuals with damp cloth
Disposal: Place waste material in approved chemical waste container for proper disposal
Reporting: Report large spills to regulatory authorities in accordance with local requirements
Handling: Avoid dust generation and direct inhalation, handle with care using suitable PPE, wash hands after handling
Storage: Store in tightly closed original container in a dry, well-ventilated location away from incompatible substances
Incompatibilities: Avoid storage near oxidizing agents, acids, and moisture
Specific End Use Practices: Use within expiration period, follow pharmaceutical handling procedures if applicable
Ventilation: Use local exhaust ventilation or work in a fume hood to minimize airborne dust
Respiratory Protection: Use NIOSH-approved dust mask or respirator if exposure limit is exceeded or dust is generated
Hand Protection: Use chemical-resistant gloves, preferably nitrile, change regularly
Eye Protection: Safety goggles meeting ANSI standard
Skin Protection: Wear laboratory coat or disposable protective clothing
Hygiene Measures: Wash hands thoroughly after handling, do not eat or drink near material, remove contaminated clothing immediately
Exposure Limits: No OSHA, ACGIH, or NIOSH exposure limits established for nitazoxanide; minimize dust generation and exposure as a precautionary practice
Appearance: Yellow crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH (1% solution): Slightly acidic
Melting Point: 205-210°C (401-410°F)
Boiling Point: Decomposes before boiling
Flash Point: Not determined
Evaporation Rate: Not applicable
Flammability: Not flammable under standard conditions
Explosion Limits: No data available
Vapor Pressure: Negligible at room temperature
Vapor Density: Not applicable
Solubility: Slightly soluble in water, soluble in organic solvents such as dimethyl sulfoxide (DMSO), ethanol
Partition Coefficient: log Pow ≈ 2.3
Decomposition Temperature: >210°C
Viscosity: Not applicable
Chemical Stability: Stable under normal handling and storage
Reactivity: No hazardous reactions expected under recommended conditions
Conditions to Avoid: Exposure to strong oxidizing agents, moisture, excessive heat, direct sunlight
Incompatible Materials: Strong oxidizers, reducing agents, acids
Hazardous Decomposition Products: Toxic fumes of carbon oxides, nitrogen oxides, sulfur oxides
Polymerization: Will not occur
Acute Toxicity: Oral LD50 (rat): >5,000 mg/kg, considered low toxicity
Skin Irritation: Not an irritant based on animal studies
Eye Irritation: May cause mild irritation upon direct contact
Respiratory Sensitization: No data available, dust may irritate upper airway
Chronic Toxicity: Animal studies show no evidence of carcinogenic or mutagenic risk at therapeutic doses
Other Effects: No reproductive or developmental toxicity identified in laboratory evaluations
Target Organs: No specific target organ effects identified in available data
Additional Information: Typical therapeutic doses safe for human use under medical supervision, overdosing may lead to gastrointestinal discomfort, yellowish discoloration of urine and sclera, headaches
Eco-toxicity: Limited data suggest aquatic toxicity is low, expected to degrade naturally
Mobility: Low mobility in soil due to low water solubility, tends to bind to sediment
Persistence and Degradability: Not persistent in environment, breaks down by hydrolysis and microbial action
Bioaccumulation: Unlikely to bioaccumulate due to limited lipid solubility
Other Adverse Effects: Not expected to disrupt wastewater treatment microorganisms at medicinal concentrations
Disposal Methods: Dispose unresolved material via licensed chemical waste disposal contractor, incineration recommended for bulk waste
Unused Products: Return to supplier or dispose as hazardous waste in compliance with local, regional, and national regulations
Contaminated Packaging: Rinse and dispose of containers per regulatory requirements, avoid reuse
Special Precautions: Prevent release to environment, do not dump down drain
Regulations: Follow local, national, and regional guidelines for disposal of pharmaceutical products
UN Number: Not regulated as a hazardous material for transportation
Proper Shipping Name: Not classified as dangerous goods
Transport Hazard Classes: Not applicable
Packing Group: Not assigned
Environmental Hazards: Not an environmental hazard for transportation regulations
Special Precautions: Avoid rough handling, keep packaging intact and protected from physical damage
US Federal Regulations: Not listed under SARA, TSCA inventory
EU Regulations: Not classified as hazardous under Regulation EC No 1272/2008 (CLP)
Label Requirements: Pharmaceutical-grade labels with product name, batch, and safety instructions
Other Labels: No additional hazard labeling needed for transport or consumer formulation
Medical Use Regulation: Approved for use by prescription as antiparasitic agent in many jurisdictions
Workplace Regulation: No occupational exposure limits set, standard PPE recommended for chemical handling
Other Global Lists: Not classified as hazardous for marine, air, or ground shipment under international agreements
