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Material Safety Data Sheet: Rifapentine

Identification

Product Name: Rifapentine
Chemical Formula: C47H64N4O12
Molecular Weight: 877.04 g/mol
Synonyms: Priftin, Rifampin derivative
Recommended Use: Pharmaceutical synthesis, anti-tuberculosis medication
Manufacturer Information: Contact varies by supplier; produced industrially under cGMP standards
Emergency Contact: Refer to local poison center or national emergency hotline

Hazard Identification

GHS Classification: Acute Toxicity (Oral) Category 4, Skin Sensitizer Category 1, Eye Irritation Category 2A
Signal Word: Warning
Hazard Statements: Harmful if swallowed; causes serious eye irritation; may cause allergic skin reaction
Pictograms: Exclamation mark
Precautionary Statements: Avoid breathing dust; wash thoroughly after handling; use protective gloves; avoid release to environment

Composition / Information on Ingredients

Chemical Name: Rifapentine
CAS Number: 61379-65-5
Concentration: >97% pure as API
Impurities: Trace rifampin analogs, water, and pharmaceutical excipients (based on form supplied)

First Aid Measures

Inhalation: Move to fresh air; seek medical advice if symptoms persist
Skin Contact: Wash with soap and water; remove contaminated clothing; seek medical attention for irritation
Eye Contact: Rinse cautiously with water for several minutes; remove contact lenses if present; seek medical help
Ingestion: Rinse mouth; contact poison control or physician immediately; do not induce vomiting without advice from medical personnel
Most Important Symptoms: Allergic reactions, eye redness, skin irritation, gastrointestinal upset

Fire-Fighting Measures

Suitable Extinguishing Media: Use foam, dry chemical, or carbon dioxide for small fires; water spray for large volumes
Specific Hazards: Combustible organic powder; may produce toxic fumes including NOx and CO under fire conditions
Special Protective Equipment: Firefighters wear full protective gear and self-contained breathing apparatus
Firefighting Instructions: Avoid inhaling smoke; prevent runoff of water used in fire control from entering the environment

Accidental Release Measures

Personal Precautions: Wear adequate personal protection (gloves, goggles, mask); keep unprotected personnel away
Environmental Precautions: Contain spill, avoid runoff to waterways
Containment: Sweep up and collect spillage for safe disposal; ventilate area well
Clean-up Methods: Clean with damp cloth to minimize dust; store waste in sealed, labeled containers
Decontamination: Wash area with detergent and water after removal of bulk material

Handling and Storage

Precautions for Handling: Avoid generation of dust; wear personal protective equipment; use in well-ventilated areas
Hygiene Practices: Do not eat, drink, or smoke when working with the material
Storage Conditions: Store in tightly sealed containers at 2–8°C; keep out of reach of unauthorized personnel
Incompatibilities: Avoid contact with strong oxidizers and reducing agents
Specific Use: Handle as pharmaceutical-grade active substance

Exposure Controls and Personal Protection

Engineering Controls: Use laboratory fume hood or downflow booth to prevent inhalation; provide local exhaust ventilation
Eye Protection: Wear safety glasses or chemical goggles
Skin Protection: Use nitrile or latex gloves; wear protective clothing
Respiratory Protection: Employ NIOSH/MSHA-approved particulate respirator if air contamination arises
Exposure Limits: No established occupational exposure limits; minimize contact to lowest reasonably achievable level

Physical and Chemical Properties

Appearance: Reddish-orange powder
Odor: Odorless
Melting Point: 190–200°C (decomposes)
Solubility: Sparingly soluble in water; soluble in DMSO, methanol, and chloroform
pH: Neutral to slightly acidic (aqueous suspension)
Vapor Pressure: Negligible at room temperature
Density: 1.4–1.7 g/cm³
Other Properties: Light sensitive; stable under recommended storage

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Conditions to Avoid: Exposure to light, moisture, elevated temperatures
Reactivity: Non-reactive under standard laboratory conditions
Incompatible Materials: Strong oxidizers, acids, bases
Hazardous Decomposition Products: CO, CO₂, nitrogen oxides under thermal decomposition

Toxicological Information

Routes of Exposure: Oral, dermal, inhalation, ocular
Acute Toxicity: LD50 (oral, rat) > 500 mg/kg
Skin Sensitization: May cause allergic dermatitis in sensitive individuals
Eye Effects: May cause moderate irritation
Chronic Effects: Prolonged exposure not well studied in non-clinical settings; known to induce hepatic enzyme activity
Carcinogenicity: Not classified as carcinogen by IARC, OSHA, or NTP
Other Effects: Possible orange-red discoloration of body fluids with systemic exposure

Ecological Information

Ecotoxicity: Limited aquatic data; pharmaceuticals like rifapentine may impact bacterial/microbial populations in wastewater
Persistence and Degradability: Biodegradability in the environment not fully evaluated
Bioaccumulation: Potential for moderate bioaccumulation; minimize release to environment
Mobility in Soil: Likely to bind to soil particles; variable mobility
Other Adverse Effects: Avoid release to aquatic systems due to antibiotic resistance risk

Disposal Considerations

Waste Disposal: Dispose of as hazardous pharmaceutical waste according to local regulations
Container Disposal: Rinse thoroughly before recycling or disposal; follow incineration protocols for pharmaceuticals
Precautions: Prevent waste from entering water supplies or natural waterways; seek advice from licensed waste disposal contractor

Transport Information

UN Number: Not classified as dangerous for transport
UN Shipping Name: Rifapentine, bulk pharmaceutical ingredient
Transport Hazard Class: Not regulated
Packing Group: Not applicable
Special Precautions: Protect from physical damage, moisture, and direct sunlight during transit

Regulatory Information

Inventory Status: Compliant with applicable national and international pharmaceutical regulations
Labeling: Complies with GHS and local HazCom requirements
Other Regulations: Prescription-only status in most jurisdictions; subject to DEA and FDA oversight in the US
SARA Title III: Not listed as hazardous substance
OSHA: Not classified as hazardous under OSHA hazard communication standard (29 CFR 1910.1200); handle as potentially bioactive substance