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Product Name: Rifaximin
Chemical Formula: C43H51N3O11
CAS Number: 80621-81-4
Synonyms: Xifaxan, Rifamycin SV derivative
Recommended Use: Pharmaceutical antibiotic used for treatment of gastrointestinal infections
Manufacturer Information: Contact pharmaceutical supplier or large-scale producer for latest data and support documentation
Emergency Telephone Number: Local poison control center or emergency medical response contact
Physical Appearance: Red to orange crystalline powder
GHS Classification: Not classified as hazardous by GHS criteria for health or environment
Potential Health Effects: May cause mild eye and skin irritation on contact; dust may cause respiratory discomfort
Precautionary Statements: Avoid contact with skin, eyes, and clothing; do not inhale dust
Signal Word: None required under GHS
Label Elements: None required under GHS criteria
Hazard Pictograms: No pictogram mandated
Route of Exposure: Inhalation, skin, eyes, ingestion
Chemical Name: Rifaximin
Chemical Family: Rifamycin antibiotic
Proportion: 100% active ingredient in bulk form
Impurities: Pharmaceutical grade suppliers specify impurities below recognized safety thresholds
Formulation Additives: Finished medication may contain excipients such as lactose, cellulose, and magnesium stearate, specific to final product
Eye Contact: Flush with plenty of water for at least fifteen minutes; seek medical attention if irritation persists
Skin Contact: Wash area with soap and water; remove contaminated clothing and launder before reuse
Inhalation: Move subject to fresh air immediately; seek medical attention if respiratory symptoms occur
Ingestion: Request medical attention; rinse mouth with water; do not induce vomiting unless directed by medical personnel
Most Important Symptoms: Mild irritation of mucous membranes, possible allergic reaction in sensitized individuals
Suitable Extinguishing Media: Water spray, dry chemical, foam, or carbon dioxide
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, nitrogen oxides, and low molecular weight organic compounds
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and full protective clothing
Special Fire-Fighting Procedures: Avoid inhaling combustion products; evacuate area if necessary; use proper extinguishing technique to control localized fire
Explosion Hazard: Rifaximin dust may form explosive mixtures with air in confined spaces; take routine precautions for fine organic powders
Personal Precautions: Use appropriate personal protective equipment; avoid inhaling dust or allowing skin contact
Environmental Precautions: Prevent entry into sewers, surface water, and soil; contain and collect spillage
Methods for Clean-Up: Sweep or vacuum spilled material using equipment with HEPA filtration and place in suitable container for disposal; avoid generating dust
Decontamination: Wash contaminated area with water and detergent after removal of bulk material
Emergency Procedures: Evacuate non-essential personnel and ventilate area; restrict access until cleaning complete
Handling Recommendations: Minimize dust generation and accumulation; use with adequate ventilation and local exhaust; do not eat, drink, or smoke while handling; wash hands thoroughly after use
Storage Conditions: Store in a tightly sealed container in a cool, dry, well-ventilated area away from incompatible substances such as strong oxidizers
Incompatibilities: Strong acids, bases, and oxidizing agents
Packaging Materials: Glass or high-density polyethylene containers, tightly closed to prevent contamination and moisture absorption
Special Precautions: Maintain stock rotation by observing expiration dates; avoid excessive heat and light exposure to protect drug potency
Occupational Exposure Limits: No established OSHA or ACGIH limits for Rifaximin
Engineering Controls: Local exhaust ventilation and general room ventilation as needed; employ negative pressure enclosures if handling large amounts
Personal Protective Equipment: Chemical-resistant gloves; lab coat or apron; safety goggles or face shield; respiratory protection if airborne dust risk exists
Hygiene Measures: Wash hands thoroughly after handling; do not touch face or exposed skin before washing
Monitoring Methods: Regular workplace air sampling and surface sampling for pharmaceutical compounds in manufacturing settings
Appearance: Orange to red crystalline powder
Odor: Odorless or faint slight odor
Molecular Weight: 785.88 g/mol
Melting Point: 201–205°C
Solubility: Practically insoluble in water, sparingly soluble in methanol, soluble in dimethyl sulfoxide
pH: 5.5–7.5 in 1% aqueous suspension
Boiling Point: Not applicable (decomposes prior to boiling)
Flash Point: No data available
Vapor Pressure: Not relevant at ambient temperatures
Density: Approximately 1.38 g/cm³
Partition Coefficient (log P): 0.9 (octanol/water)
Chemical Stability: Rifaximin remains stable under recommended storage conditions
Conditions to Avoid: Direct sunlight, excessive moisture, strong oxidizing agents, open flame
Incompatible Materials: Strong acids, strong bases, oxidizers
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, and possibly toxic low molecular weight organic compounds
Polymerization: Does not undergo hazardous polymerization under normal conditions
Acute Toxicity: LD50 (oral, rat) > 5000 mg/kg; considered low acute toxicity
Chronic Effects: Long-term studies do not indicate carcinogenic or mutagenic effects at therapeutic doses
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Symptoms: Mild respiratory irritation, dermatitis with prolonged exposure, gastrointestinal upset if ingested in large quantities
Target Organs: Data suggest low systemic absorption; most effects remain localized to gastrointestinal tract
Sensitization: Not classified as a sensitizer but rare allergic reactions have been documented
Carcinogenicity: Not listed by IARC, NTP, or OSHA as a carcinogen
Ecotoxicity: Limited acute aquatic toxicity; chronic exposure and cumulative risk data remain sparse
Persistence and Degradability: May persist in the environment; slow to biodegrade in soil and water due to low solubility
Bioaccumulative Potential: Log P suggests moderate bioaccumulation unlikely
Mobility in Soil: Immobile in soil; binds strongly to soil particles
Other Adverse Effects: Consider potential impact on aquatic organisms and possible development of antimicrobial resistance in water treatment ecosystems
Product Disposal: Dispose in accordance with local, regional, and national regulations by incineration or pharmaceutical waste programs
Container Disposal: Rinse empty containers, render unusable, then send for controlled landfill or incineration
Special Precautions: Do not discharge into sewer systems; consult relevant guidelines for pharmaceutical waste
Recommended Methods: Controlled incineration at licensed facility with suitable emission controls to capture breakdown products
Regulatory Requirements: Check waste generator category and local pharmacy take-back policies
UN Number: Not classified as a hazardous material for transport
Proper Shipping Name: Rifaximin
Transportation Hazard Class: Not regulated as dangerous goods for air, sea, or road transport
Packing Group: Not applicable
Marine Pollutant: Not identified as a marine pollutant
Special Precautions: Prevent container breakage or spillage during loading, transport, and unloading
U.S. Regulations: Rifaximin not listed on SARA Title III, Section 313 or EPA TSCA; FDA regulates as a prescription pharmaceutical
European Union Regulations: Listed as active pharmaceutical ingredient under ECHA REACH for monitoring and control
OSHA Status: Not considered hazardous under OSHA criteria
WHMIS Classification (Canada): Not controlled
Other Regulatory Listings: Not a controlled substance; compliance governed by pharmaceutical manufacturing, handling, and waste disposal guidelines as set by local jurisdictions
