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Product Name: Rabeprazole Sodium
Chemical Name: 2-[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]methylsulfinyl]-1H-benzimidazole sodium salt
Synonyms: Acidil, Pariet, Rabecid, Rabeprazole Sodium Salt
CAS Number: 117976-89-3
Intended Use: Pharmaceutical intermediate, Active pharmaceutical ingredient for treating gastrointestinal disorders
Manufacturer Details: Refer to supplier's documentation
Emergency Contact: Refer to local manufacturer or supplier's emergency number
Classification: Not classified as hazardous under GHS criteria for pure active substance
Signal Word: None
Hazard Statements: May cause mild irritation to eyes, respiratory tract, or skin on contact or prolonged exposure
Health Hazard: On ingestion, potential gastrointestinal discomfort or disturbance
Environmental Hazard: No significant hazards reported at normal environmental concentrations
Pictograms: None recommended for bulk solid
Chemical Name: Rabeprazole Sodium
Concentration: 100% (for pure API form)
Impurities: Trace pharmaceutical process byproducts may occur under manufacture; specifications typically disclose less than parts per million levels
Molecular Formula: C18H20N3NaO3S
Molecular Weight: 381.42 g/mol
Eye Contact: Rinse immediately with plenty of clean water for at least 15 minutes while holding eyelids open. Seek medical attention if irritation occurs.
Skin Contact: Remove contaminated clothing, wash skin gently with soap and plenty of water. If irritation develops, seek medical advice.
Inhalation: Move to fresh air promptly. If breathing becomes difficult, consult a physician.
Ingestion: Rinse mouth thoroughly, drink water if conscious. Do not induce vomiting unless instructed by medical professional. Get medical assistance if large amounts are swallowed or symptoms present.
Suitable Extinguishing Media: Use water spray, dry chemical, foam, or carbon dioxide. Select extinguishing agent based on surrounding fire.
Specific Hazards: Thermal decomposition can release toxic fumes of nitrogen oxides, sulfur oxides, and carbon monoxide.
Special Protective Equipment: Use self-contained breathing apparatus plus full protective clothing to prevent contact with skin and eyes.
Advice for Firefighters: Avoid inhalation of smoke, keep containers cool by spraying with water from a safe distance. Dispose of contaminated extinguishing media following local guidelines.
Personal Precautions: Evacuate unnecessary personnel, ventilate area. Avoid dust formation. Wear appropriate PPE including gloves, goggles, dust mask or respirator as needed.
Environmental Precautions: Prevent substance from entering drains, surface waters, or soil. Avoid large-scale disposal into environment.
Cleanup Methods: Use inert absorbent materials. Sweep up, transfer carefully to labeled, sealed containers for waste disposal. Wash spill area with water and detergent. Do not use compressed air to remove dust.
Disposal: Follow local, regional, and national guidelines for pharmaceutical waste handling.
Precautions for Safe Handling: Minimize dust generation and accumulation. Wear appropriate PPE. Do not eat, drink, or smoke while handling the product. Practice good industrial hygiene—wash hands thoroughly after handling.
Conditions for Safe Storage: Store in tightly closed original container, in a cool, dry, well-ventilated place out of direct sunlight and away from moisture and incompatible substances. Avoid sources of ignition and excessive temperatures. Keep away from foodstuffs and incompatible chemicals. Clearly label all secondary containers.
Engineering Controls: Use local exhaust or general ventilation. Enclose process if dust or aerosols can form.
Eye/Face Protection: Safety goggles or face shield recommended around powder or during cleaning.
Skin Protection: Wear chemical-resistant gloves (nitrile, rubber), lab coat, and closed footwear.
Respiratory Protection: Use certified particulate respirator if dust levels high or ventilation poor.
Hygiene Measures: Avoid prolonged skin contact. Wash hands after use. Do not reuse contaminated personal protective equipment.
Appearance: White to off-white crystalline powder
Odor: Odorless or nearly odorless
pH: 8–11 (as an aqueous solution)
Melting Point: Decomposes above 200°C
Boiling Point: Not available (decomposes prior to boiling)
Solubility: Freely soluble in methanol, slightly soluble in water
Vapor Pressure: Negligible at room temperature
Partition Coefficient (log P): Estimated 3 (octanol/water)
Flash Point: Not applicable
Density: 1.4–1.5 g/cm³ (approximate)
Stability: Stable under normal storage and handling conditions
Chemical Stability: Product remains stable in sealed containers under dry, ambient conditions
Conditions to Avoid: Exposure to heat, moisture, direct sunlight, and incompatible substances like strong oxidizers
Hazardous Reactions: No known hazardous polymerization
Decomposition Products: Toxic and corrosive gases including sulfur oxides, nitrogen oxides, and carbon monoxide can form on thermal decomposition
Incompatibilities: Strong oxidizing agents, acids, and bases may react with the API
Acute Toxicity: LD50 (oral, rat): >2000 mg/kg
Chronic Effects: Overexposure might affect gastrointestinal system after repeated administration
Carcinogenicity: Not classified as cancer-causing by IARC, NTP, or ACGIH
Mutagenicity: Not mutagenic based on in vitro and in vivo assays
Reproductive Toxicity: No adverse reproductive or developmental effects observed in animal studies at standard therapeutic doses
Other Effects: Dust or bulk powder can cause mild irritation to mucous membranes
Ecotoxicity: Not classified as environmentally hazardous at low concentrations. Limiting environmental exposure always makes sense with pharmaceuticals.
Persistence/Degradability: Not rapidly biodegradable. May persist in water and soil.
Bioaccumulative Potential: Limited bioaccumulation predicted; log P suggests moderate partitioning.
Mobility in Soil: Moderate mobility possible
Other Effects: Local regulations often restrict uncontrolled disposal; targeted management in pharmaceutical facilities better protects water systems and soil.
Waste Treatment Methods: Dispose in accordance with relevant national, regional, and local laws for pharmaceutical waste.
Disposal of Containers: Triple rinse and render unusable before recycling or landfilling as non-hazardous waste if permitted.
Sewage Disposal: Do not flush to sewer, surface waters, or soil.
Contaminated Packaging: Follow standard disposal practices for laboratory chemical containers.
Additional Information: Incineration in hazwaste facility recommended for excess and contaminated product.
UN Number: None assigned
UN Proper Shipping Name: Not regulated under standard transportation rules
Transport Hazard Class: Not classed as dangerous goods
Packing Group: None
Special Precautions for User: Avoid rough handling or stacking that could break containers or cause spills. Label all shipments according to shipment documentation. Protect from mechanical damage and moisture exposure during transit.
TSCA Status: Not listed for use other than as an active pharmaceutical
EU Regulations: Compliant with REACH for registered pharmaceutical substances
OSHA Hazard Communication: Not regulated as hazardous
WHMIS Classification (Canada): Not classified
Other Regulations: Strict handling and record-keeping for pharmaceutical production settings govern workplace safety, emissions, and disposal. Product remains for prescription use only as a regulated medical compound.
