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Product Name: Dabigatran Etexilate Mesylate
Chemical Formula: C35H41N7O8·CH4O3S
CAS Number: 211915-06-9
Synonyms: Dabigatran etexilate, Pradaxa
Intended Use: Anticoagulant pharmaceutical, direct thrombin inhibitor
Manufacturer: As listed on the original packaging
Contact Number (Emergency): Check local poison control center or manufacturer contact on label
Address: Refer to manufacturer’s literature for latest contact details
Email for SDS Request: Manufacturer-provided address on packaging
Recommended Use Restrictions: For prescription and professional medical use only; not suitable for over-the-counter sale or self-medication
Classification: Classified as hazardous under Regulation EC 1272/2008 (CLP)
Hazard Statements: Causes serious eye irritation (H319), May cause respiratory irritation (H335), May cause allergic skin reaction (H317), Harmful if swallowed (H302), May cause organ damage through prolonged or repeated exposure (H373), Harmful to aquatic life with long lasting effects (H412)
Label Elements: Exclamation mark symbol, Health hazard pictogram
Precautionary Statements: Avoid breathing dust or vapors, Wear personal protective equipment, Wash thoroughly after handling, Do not eat, drink, or smoke while handling this substance, Avoid release to the environment
Route of Exposure: Ingestion, inhalation, skin and eye contact
Target Organs: Blood, kidneys, liver, mucous membranes
Chemical Name: Dabigatran Etexilate Mesylate
Concentration: 98%-100% (Active Ingredient)
CAS Number: 211915-06-9
Impurities: Less than 2%, depending on batch and manufacturer details
Other Additives: Typically comes in pure form for compounding; excipients may apply in finished dose formulations like tablets or capsules
Inhalation: Move person to fresh air immediately; seek medical attention for persistent symptoms—look for coughing, sneezing, shortness of breath
Skin Contact: Wash exposed skin thoroughly with soap and water; remove contaminated clothing and wash before reuse; get medical advice if rash or irritation develops
Eye Contact: Rinse cautiously with water for several minutes; remove contact lenses if present and easy to do; seek professional ophthalmological evaluation if irritation persists
Ingestion: Rinse mouth, do not induce vomiting, seek emergency medical or poison center advice immediately due to potential for bleeding risks
Acute Symptoms: Irritation, allergic reactions, bleeding tendencies, mucous membrane discomfort
Delayed Symptoms: Abnormal bruising or bleeding, immune hypersensitivity, headache, gastrointestinal effects
Suitable Extinguishing Media: Use water spray, dry chemical, foam, or carbon dioxide for small fires involving tablets or powder
Unsuitable Extinguishing Media: High pressure water jets may spread powder
Hazards from Combustion: Emits toxic fumes including oxides of carbon, nitrogen, and sulfur when burned
Protective Equipment: Firefighters should use self-contained breathing apparatus and full protective clothing
Firefighting Instructions: Surround and cool unaffected containers; prevent runoff from entering water sources; stay upwind of smoke
Personal Precautions: Evacuate unnecessary personnel; avoid dust formation and inhalation; wear gloves, goggles, and suitable respiratory protection
Environmental Precautions: Prevent further spillage if safe; keep away from drains, surface and groundwater due to aquatic toxicity concerns
Methods for Clean-Up: For powder, carefully sweep up to avoid dust; for solutions, absorb with inert material; place waste in sealed containers for proper disposal
Decontamination: Clean affected surfaces with detergent and water; check for hidden contamination behind or under workspaces
Handling: Handle within a laboratory chemical fume hood or pharmaceutical isolator to minimize exposure; avoid breathing dust or exposure to skin or eyes; keep away from food and beverages
Storage: Store in a tightly closed original container in a cool, dry, well-ventilated area; protect from light, moisture, and incompatible substances; keep away from children and unauthorized staff
Incompatibilities: Strong oxidizing agents, acids, bases
Special Requirements: Follow local pharmaceutical storage and security protocols, including record-keeping for controlled inventory tracking
Engineering Controls: Use local exhaust ventilation, fume hoods, and closed transfer systems to keep exposure below occupational exposure limits
Personal Protective Equipment: Lab coat or gown, chemical-resistant gloves (nitrile preferred), safety glasses with side shields, fit-tested particulate respirator for airborne powder handling
Hygiene Measures: Avoid eating, drinking, or smoking in work area; wash hands and face after handling; remove contaminated clothing immediately
Occupational Exposure Limits: No established limits for dabigatran etexilate, follow internal risk assessment guidance for cytotoxic drugs where relevant
Environmental Controls: Prevent accidental release into soil or water systems; use spill containment tools in storage/dispensing areas
Appearance: White to pale yellow crystalline powder
Odor: Odorless or slight chemical odor
Odor Threshold: Not determined
Melting Point/Range: 118°C to 121°C
Boiling Point: Not applicable; decomposes at high temperatures
Solubility: Slightly soluble in water, freely soluble in methanol and ethanol
pH (Aqueous Solution): 2-4 (as mesylate salt in solution)
Vapor Pressure: Not measurable at ambient conditions
Molecular Weight: 627.7 g/mol (free base), 627.76 g/mol (mesylate)
Partition Coefficient (Log Pow): 4.8 (estimated)
Auto-Ignition Temperature: Not established
Explosive Properties: Not considered explosive under standard handling conditions
Viscosity: Not applicable (solid)
Chemical Stability: Stable under recommended storage and handling conditions
Possible Reactions: Can react with strong oxidizers to produce hazardous compounds; avoid exposure to acids/bases for prolonged periods
Decomposition Products: Smoke, carbon monoxide, nitrogen oxides, sulfur oxides under combustion
Hazardous Polymerization: Not anticipated under normal circumstances
Conditions to Avoid: Elevated temperature, exposure to light, moisture ingress
Incompatibilities: Strong oxidizing agents, acid chlorides, acid anhydrides
Acute Toxicity: Oral LD50 (rat): >2000 mg/kg (literature estimate, specificity may vary)
Inhalation: May cause coughing, respiratory discomfort, dizziness
Skin and Eye Irritation: Can cause mild to moderate irritation, redness, or allergic response
Sensitization: Possible in certain individuals with repeated or high exposure
Chronic Effects: Prolonged or repeated use may lead to abnormal bleeding, hematological changes, possible impact on liver and kidney function
Carcinogenicity: No clear evidence of carcinogenicity in standard studies to date
Mutagenicity: Negative in most genotoxicity tests
Reproductive Toxicity: Not established in humans; animal models indicate minimal risk at therapeutic doses
Symptoms: Bleeding, bruising, dizziness, gastrointestinal discomfort, mild allergic reactions
Ecotoxicological Effects: Harmful to aquatic organisms, especially in large accidental releases
Persistence and Degradability: Degrades in the environment over longer periods; active metabolite may persist in water
Bioaccumulation Potential: Low to moderate (predicted based on log Pow and animal studies)
Mobility in Soil: Likely to bind to soil particles; marginal mobility across layers
Other Concerns: Trace pharmaceutical residues can affect aquatic life, so take care to prevent release into sewer systems
Product Disposal: Dispose of unused dabigatran etexilate and contaminated containers as hazardous pharmaceutical waste, according to local, regional, and national regulations
Method: Use licensed hazardous waste contractor; incineration in approved facility preferred for minimizing long-term environmental exposure
Contaminated Packaging: Empty containers should be triple-rinsed or handled as hazardous waste
Precautions: Never dispose down a drain, toilet, or in general municipal waste streams
UN Number: UN3249 (Pharmaceuticals, solid, toxic, n.o.s.)
Proper Shipping Name: Pharmaceutical preparation containing dabigatran etexilate
Transport Hazard Class: Class 6.1 (Toxic substances)
Packing Group: III
Labels Required: Toxic (skull and crossbones symbol), if shipped as bulk powder
Special Precautions: Avoid rough handling, shocks or drop. Keep container sealed and dry during transit; refer to local and international transport regulations (ADR, IMDG, IATA)
Classification and Labeling: Subject to Regulation (EC) No 1272/2008, US OSHA HazCom 2012, and WHMIS standards
Inventory Listing: Registered substance under country-specific pharmaceutical laws (FDA, EMA, PMDA, TGA as applicable)
Restrictions on Use: Prescription-only, hospital and pharmacy professionals
Other Regulations: Covered by workplace exposure controls for cytotoxic drugs and hazardous substances; specific rules apply for handling, tracking, and reporting unusual adverse reactions
Occupational Health: All handlers must be trained in safe chemical management and emergency measures; ongoing assessment as new data becomes available
