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Product Name: Telbivudine
Chemical Name: 1-[(2R,4S,5S)-4-Amino-5-(hydroxymethyl)oxolan-2-yl]-5-methylpyrimidine-2,4-dione
CAS Number: 269716-72-7
Synonyms: LdT, L-thymidine, β-L-thymidine
Recommended Use: Antiviral pharmaceutical ingredient
Supplier Details: Pharmaceuticals manufacturer or authorized distributor, address and emergency contact provided on invoice or labeling
Emergency Phone: Emergency medical or poison control center phone, available on local packaging or distributor safety documentation
GHS Classification: Not classified as hazardous under normal circumstances, but prudent precaution necessary due to limited toxicity data for bulk drug powders
Health Hazards: May cause mild skin, eye, or respiratory irritation, especially in fine particulate or powder form; effects from accidental ingestion or dust inhalation have not been fully established for workers outside pharmaceutical settings
Physical Hazards: No significant physical hazard in tablet form, but dust may present risk of respiratory irritation
Environmental Hazards: Reported low risk to aquatic environments, but bulk release can raise local and regional water toxicity for sensitive aquatic species
Signal Word: None required in therapeutic use, recommended use of "Caution" for bulk or powdered handling
Ingredient: Telbivudine
Purity: ≥98% for pharmaceutical grade
Form: Powder or tablets, bulk material appears as white or nearly white crystalline powder
Key Impurities: Synthetic intermediates, organic solvents, decomposition products present at ≤0.1% in qualified batches
Other Additives: Excipients only in finished dose (tablet) products; active ingredient presents main exposure risk in manufacturing
Inhalation: Move to fresh air, keep under observation for persistent cough or irritation. If symptoms persist, contact a physician.
Skin Contact: Wash thoroughly with soap and water. Remove contaminated clothing. Immediate flushing with water advised for skin exposure.
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do.
Ingestion: Rinse mouth; seek medical advice in case of accidental ingestion of large quantities especially for non-patient handlers.
Most Significant Symptoms: Irritation, mild discomfort in non-patient exposure settings. Severe toxicity from accidental exposure highly unlikely due to low acute toxicity profile.
Suggestions for Physicians: Treat symptomatically; monitor for allergic reactions or other non-specific responses
Suitable Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or alcohol-resistant foam
Specific Hazards: Combustion in bulk produces toxic fumes (nitrogen oxides, carbon monoxide)
Protective Equipment: Wear self-contained breathing apparatus and full firefighting gear when handling large quantities
Unusual Fire or Explosion Hazards: Fine dust may pose slight explosion risk in confined spaces. Avoid airborne dispersion of powder in enclosed areas
Personal Protective Measures: Use gloves, goggles, and particulate respirator for cleanup. Prevent powder from becoming airborne
Environmental Precautions: Confine spill, avoid discharge to drains or natural waterways. Use absorbent materials and sweep up spills promptly
Methods for Cleanup: Use vacuum with HEPA filter or damp sweeping; avoid creating dust. Store contaminated materials in sealed containers for disposal
Decontamination: Clean surfaces with water and appropriate detergent to remove residue
Handling Practices: Avoid contact with skin, eyes, and clothing. Use engineering controls like local exhaust ventilation; minimize dust generation
Safe Storage Conditions: Store in tightly closed containers in cool, dry, well-ventilated areas away from incompatible substances such as strong oxidizers
Hygiene Practices: Wash hands thoroughly after handling, before breaks, and at the end of the shift; do not eat, drink, or smoke in work areas where this drug is processed or compounded
Special Requirements: Restrict access to trained personnel; maintain appropriate documentation in accordance with pharmaceutical safety requirements
Occupational Exposure Limits: No occupational limits set for Telbivudine. Adopt methods modeled on similar antiviral drugs—keep airborne concentrations as low as reasonably achievable
Engineering Controls: Local exhaust ventilation and use of closed system transfer devices or ventilated weighing enclosures recommended for bulk pharmaceuticals
Respiratory Protection: Use NIOSH-approved disposable respirators when risk of dust exposure exists
Skin Protection: Nitrile or latex gloves recommended. Protective clothing or lab coat advised for large-scale handling
Eye Protection: Chemical splash goggles or face shield, especially during cleaning, transfer, or any operation with dust generation
Appearance: White to off-white crystalline powder
Odor: Odorless
Melting Point: 160–165°C (320-329°F)
Boiling Point: Not applicable for solid material
Solubility: Soluble in water
pH: No data for powdered bulk; aqueous solutions typically neutral to mildly acidic
Vapor Pressure: Not applicable
Density: Approx. 1.7 g/cm³
Partition Coefficient (log Pow): Estimated -1.09 (high water solubility, low lipophilicity)
Stability: Stable under normal temperatures and storage conditions
Chemical Stability: Stable under recommended storage conditions
Incompatible Materials: Strong oxidizing agents may degrade telbivudine or produce hazardous decomposition products
Hazardous Decomposition: Nitrogen oxides, carbon oxides may form under fire conditions
Conditions to Avoid: Prolonged exposure to heat, moisture, or direct sunlight may cause slow decomposition
Polymerization: No risk of hazardous polymerization under normal handling
Acute Toxicity: Oral LD50 (rat and mouse): >2 g/kg—low acute toxicity; inhalation and dermal toxicity not established but considered low based on structure
Skin/Eye Irritation: Mild irritation possible on prolonged or repeated contact
Sensitization: No data on skin sensitization in workers. Allergic reactions in patients have not been reported in clinically relevant numbers
Chronic Toxicity: No evidence of carcinogenicity, mutagenicity, or reproductive toxicity at therapeutic exposures
Other Health Effects: Pharmacological activity likely only at much higher exposures than encountered by most workers
Ecotoxicity: No significant risk in typical environmental concentrations, but high concentrations in pharmaceuticals industry effluents could stress aquatic organisms
Mobility: High water solubility; can migrate through soil and reach surface or groundwater if released in bulk
Persistence: Expected to be biodegradable under environmental conditions, but slow breakdown possible in low-microbe areas
Bioaccumulation: No evidence of significant bioaccumulation due to low lipophilicity and rapid breakdown in mammals
Aquatic Toxicity: No specific data, but structurally similar nucleoside analogues present low chronic toxicity to fish and invertebrates after dilution
Waste Disposal Methods: Treat as pharmaceutical waste. Incinerate in approved chemical incinerator with afterburner and scrubber
Unused Product: Return to licensed disposal contractors or pharmaceutical take-back programs
Contaminated Packaging: Triple rinse containers; offer for recycling or incineration where permitted
Avoid Release: Keep out of sewage, natural watercourses, and soil
Regulatory Notes: Handle solid and powder residues as hazardous waste unless local ordinances specify otherwise
UN Shipping Name: Not classified as a dangerous good under UN, IATA, or IMDG regulations
Transport Hazard Class: Not assigned
Packaging Requirements: Use leak-proof, sealed containers; shield from direct sunlight and moisture during transport
Special Precautions: Ensure container labeling and documentation accompany every shipment for all bulk quantities, follow local and national pharmaceutical shipping regulations
Environmental Hazards: No marine pollutant designation; caution with bulk accidental release
Global Inventories: Registered pharmaceutical active ingredient in most major jurisdictions
OSHA/WHMIS: Not listed as hazardous under conventional chemical safety legislation
IARC/NTP Classification: Not listed as probable or suspected carcinogen
Drug Control Regulations: Prescription-only medicine, subject to pharmaceutical regulations and medical oversight
REACH/TSCA: Exempt as a medicinal product in finished and labeled forms; API handling subject to chemical safety requirements in EU/US manufacturing
Worker Training: Employers ensure access to safety data, hazard communication per occupational health law
