Product Name: Rivastigmine Hydrogentartrate
Chemical Formula: C14H22N2O2·C4H6O6
CAS Number: 129101-54-8
Synonyms: Rivastigmine hydrogen tartrate, ENA 713 hydrogen tartrate
Recommended Use: Active pharmaceutical ingredient for neurodegenerative disorders
Manufacturer: Refer to supplier or production facility details
Contact Information: Emergency telephone and supplier contact provided on specific labels
Classification: Acute Toxicity (Oral) Category 3, Eye Irritation Category 2A
Signal Word: Danger
Hazard Statements: Toxic if swallowed. Causes serious eye irritation. May cause respiratory irritation.
Pictograms: Skull and crossbones, exclamation mark symbols required
Precautionary Statements: Wash hands after handling. Avoid breathing dust or powder. Use only outdoors or in well-ventilated area. Wear protective gloves, eye protection, and face protection.
Chemical Name: Rivastigmine hydrogentartrate
Concentration: 98-100% pure (depends on batch specification)
Impurities: Process-related and degradation by-products present at low levels, specifications available in certificate of analysis.
Molecular Weight: 400.43 g/mol
Ingredient Status: No dangerous substances above regulatory thresholds other than the listed compound
Inhalation: Move to fresh air immediately. If breathing is difficult, provide oxygen. Get medical attention.
Skin Contact: Remove contaminated clothing. Wash skin with soap and plenty of water for at least 15 minutes. Seek medical attention if irritation persists.
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if easily possible. Continue rinsing and seek medical attention.
Ingestion: Rinse mouth. Do not induce vomiting. Never give anything by mouth to an unconscious person. Get immediate medical help.
Suitable Extinguishing Media: Use water spray, carbon dioxide, dry chemical or foam.
Specific Hazards: Combustion may produce toxic fumes of nitrogen oxides, carbon monoxide, carbon dioxide.
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and full protective gear to prevent contact with skin and eyes.
Advice for Firefighters: Move containers away from fire area if safe to do so. Cool containers with water spray. Avoid inhalation of combustion gases.
Personal Precautions: Wear personal protective equipment. Avoid breathing dust. Ensure adequate ventilation.
Environmental Precautions: Do not let product enter drains, surface water, or soil.
Containment and Cleanup: Sweep up spills carefully and collect in suitable container for disposal. Ventilate area and wash spill site after material pickup is complete. Dispose of according to local regulations.
Handling: Use in a chemical fume hood or well-ventilated area. Do not get on skin, eyes, or clothing. Avoid inhalation of dust.
Storage: Store tightly closed in a cool, dry, and well-ventilated place. Keep away from incompatible materials such as oxidizers. Protect from light and moisture.
Incompatible Materials: Strong oxidizing agents, strong acids, and strong bases.
Engineering Controls: Use local exhaust ventilation to reduce exposures.
Personal Protection: Wear protective clothing, gloves, safety goggles, and lab coat. Respiratory protection required if exposure limits are exceeded. Emergency eye wash and safety shower should be available.
Exposure Limits: No official occupational exposure limits established. Minimize exposure based on internal risk assessments.
Appearance: White to off-white crystalline powder
Odor: Odorless or slight acid odor
Melting Point: 120–130°C (decomposition may occur above this range)
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Freely soluble in water; slightly soluble in ethanol
pH (1% solution): 3–4
Vapor Pressure: Negligible at ambient temperature
Flash Point: Not applicable/actionable through standard methods.
Partition Coefficient (log Pow): Data not available
Chemical Stability: Stable under recommended storage conditions.
Conditions to Avoid: Excess moisture, light, excessive heat.
Hazardous Reactions: Unlikely under normal handling and storage, can react with strong oxidizers.
Hazardous Decomposition Products: Produces carbon oxides, nitrogen oxides under fire or decomposition.
Likely Routes of Exposure: Inhalation, ingestion, skin and eye contact.
Acute Toxicity: Oral LD50 in rodents: 0.5–1.5 mg/kg. Toxic effects include nausea, vomiting, respiratory distress, cholinergic crisis.
Chronic Toxicity: Prolonged exposure may cause symptoms consistent with excessive acetylcholinesterase inhibition.
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, or OSHA.
Irritation: May cause eye and skin irritation.
Sensitization: Data unavailable.
Ecotoxicity: Toxic effects demonstrated in aquatic organisms at low concentrations. Poses risk for chronic toxicity.
Persistence and Degradability: Slow degradation in environment.
Bioaccumulation Potential: Low bioaccumulation expected.
Mobility in Soil: May be mobile in aqueous phase.
Other Adverse Effects: Harmful to aquatic life with long lasting effects.
Waste Treatment Methods: Dispose of product and contaminated packaging as hazardous chemical waste.
Recommended Disposal: Incineration in approved facility required for bulk material. Empty containers should follow local regulations.
Environmental Precautions: Do not flush to surface water or sanitary sewer system.
UN Number: Not classified as a dangerous good for transport under IMDG, IATA, or DOT.
Proper Shipping Name: Not regulated for shipment; laboratory samples may fall under “Biochemical not otherwise specified”.
Transport Hazard Class: None assigned.
Packing Group: None assigned.
Special Precautions: Prevent movement of bulk material. Secure container to prevent accidental release.
Federal Regulations: Not listed on US TSCA inventory. Under FDA jurisdiction if used in pharmaceuticals.
EU Regulations: Subject to REACH registration exemptions for pharmaceuticals.
Other Regulations: Occupational exposure controls required in GMP manufacturing. Safety assessment must be documented per ICH guidelines.
Inventory Status: Not classified as a chemical in commercial trade. Import/export controls apply by country.
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