Product Name: Trimetazidine Dihydrochloride
Chemical Formula: C14H22N2O3·2HCl
Synonyms: 1-(2,3,4-trimethoxybenzyl)-piperazine dihydrochloride
CAS Number: 13171-25-0
Molecular Weight: 341.27 g/mol
Recommended Use: Pharmaceutical active substance
Supplier: Listed by pharmaceutical manufacturers, contact details available on purchase documentation
Emergency Contact: See manufacturer’s emergency protocol or regional poison control center
Classification: Not classified as hazardous according to current global standards (GHS system).
Hazard Statements: May cause irritation to eyes, skin, respiratory tract if mishandled.
Pictograms: None required under current regulations.
Risk Phrases: R36: Irritating to eyes. R37: Irritating to respiratory system.
Signal Word: Caution
Target Organs: Eyes, skin, respiratory tract
Chemical Identity: Trimetazidine Dihydrochloride
Concentration: ≥99% (by weight)
Impurities: Trace level process impurities not expected to alter hazard profile
Stabilizers / Additives: None
Inhalation: Move to fresh air. Seek medical attention if symptoms persist such as coughing, difficulty breathing, or throat irritation.
Skin Contact: Remove contaminated clothing. Rinse affected area with plenty of water and mild soap. Medical attention recommended if irritation develops.
Eye Contact: Rinse immediately with clean, lukewarm water for at least 15 minutes keeping eyelids open. Remove contact lenses if present and easy to do.
Ingestion: Rinse mouth with water, do not induce vomiting. Consult a physician or poison center for guidance if large amounts swallow or symptoms occur.
Note to Physician: Treat symptomatically. There is no specific antidote.
Suitable Extinguishing Media: Dry chemical, carbon dioxide, foam, or water spray can suppress fire.
Hazards from Combustion: Produces oxides of nitrogen, carbon monoxide, carbon dioxide, hydrochloric acid fumes during fire.
Protective Equipment: Fire fighters need full protective gear and self-contained breathing apparatus.
Specific Firefighting Actions: Use water spray to cool containers, and avoid breathing smoke or vapors.
Explosion Hazard: Not considered explosive, but dust accumulation may pose combustible dust risk.
Personal Precautions: Avoid breathing dust, prevent skin and eye contact.
Environmental Precautions: Prevent spillage from entering drains, surface water, soil.
Cleanup Methods: Collect spill material with absorbent (dry sand, earth) for disposal. Use tools that prevent dust generation.
Decontamination: Flush region with water after cleanup; ventilate area.
Disposal: Place in properly labeled waste container for disposal according to regulations.
Handling: Work in well-ventilated spaces, minimize dust creation, and use personal protective equipment (PPE) like gloves and goggles. Avoid inhalation and direct contact.
Storage Conditions: Store away from incompatible materials such as acids and oxidizers.
Temperature Requirements: Keep at controlled room temperature, away from heat or open flame.
Container Materials: Store in tightly closed containers made of inert materials.
Exposure Limits: No established occupational exposure limits for this compound.
Engineering Controls: Local exhaust ventilation and eye wash facilities recommended.
Personal Protection: Wear chemical-resistant gloves, safety goggles, lab coat or equivalent protective clothing.
Respiratory Protection: Use mask or respirator if dust generated or ventilation is insufficient.
Hygiene Measures: Wash hands after handling. Do not eat, drink, or smoke during use. Remove contaminated clothing immediately.
Appearance: White to off-white crystalline powder
Odor: Odorless
pH (1% solution): Approximately 4.0–6.0
Boiling Point: Data not available (decomposes prior to boiling)
Melting Point: 270–271°C (with decomposition)
Solubility: Freely soluble in water, sparingly soluble in ethanol
Vapor Pressure: Not volatile
Partition Coefficient (log Kow): Not determined
Flash Point: Not flammable in solid form
Stability in Solutions: Stable under recommended storage conditions
Chemical Stability: Remains stable under recommended handling and storage.
Reactivity: No significant hazardous reactions when used as intended.
Incompatible Materials: Strong oxidizers, strong acids.
Conditions to Avoid: Excessive heat, sources of ignition, uncontrolled humidity.
Hazardous Decomposition Products: Emits nitrogen oxides, carbon oxides, and hydrochloric acid vapors after decomposition by heat.
Acute Toxicity: Low oral toxicity in animal studies. Estimated LD50 (oral, rat): >2000 mg/kg.
Potential Health Effects: Prolonged contact may cause skin or eye irritation.
Chronic Effects: No evidence of mutagenicity, carcinogenicity, or reproductive toxicity in available data.
Sensitization: Not reported to cause skin or respiratory sensitization.
Symptoms of Exposure: Eye irritation, mild respiratory tract discomfort, skin itching.
Aquatic Toxicity: No reliable data available; not expected to be highly hazardous to aquatic environment at typical concentrations.
Persistence and Degradability: Expected to remain stable and persistent in the environment.
Bioaccumulation: Not anticipated based on structure and available data.
Mobility in Soil: Solubility in water may allow migration through soil.
Other Adverse Effects: No significant impact reported with normal pharmaceutical use and disposal.
Waste Handling: Dispose of as pharmaceutical waste, following national and local regulations.
Disposal Methods: Incineration under controlled conditions typically recommended for pharmaceutical solids.
Contaminated Packaging: Rinse thoroughly, treat as hazardous waste. Observe local requirements.
Avoid Release: Do not discard into natural environments, water bodies, or municipal waste.
UN Number: Not regulated by UN for transport
Proper Shipping Name: Not classified as dangerous for transport
Transport Hazard Class: None assigned
Packing Group: Not applicable
Environmental Hazards: Not classified as marine pollutant
Special Precautions: Avoid transport with incompatible substances, keep containers tightly closed and upright.
Inventory Status: Approved as an active pharmaceutical ingredient in several regulatory regions.
OSHA: Not specifically listed as hazardous.
REACH Status: Exempt due to pharmaceutical usage.
WHMIS Status: Not controlled under Canadian WHMIS.
Other Regulations: Complies with applicable EU, US, and international pharmaceutical regulations for transport, handling, and use.
Labeling Requirements: Standard pharmaceutical labeling for prescription substances required in relevant jurisdictions.
