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Product Name: Famciclovir
Chemical Name: 2-[2-(2-Amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate
Synonyms: Famvir
CAS Number: 104227-87-4
Recommended Use: Antiviral pharmaceutical formulation
Manufacturer: Major pharmaceutical companies licensed for production
Supplier Contact: Manufacturer’s health and safety department
Emergency Phone: Provided by local distributor or Poison Control
GHS Classification: Not classified as hazardous according to GHS criteria for pure compound, though fine dust may present inhalation risk
Signal Word: None
Hazard Statements: May cause mild eye irritation, possible sensitizer for susceptible individuals, dust poses nuisance hazard
Precautionary Statements: Avoid dust generation, use local exhaust ventilation in areas of powder manipulation, avoid contact with eyes and skin
Chronic Effects: Not classed as carcinogenic, mutagenic, or reprotoxic based on animal data
Routes of Entry: Inhalation, skin contact, eye contact, ingestion
Target Organs: No specific organ toxicity identified in therapeutic or workplace exposure models
Chemical: Famciclovir
CAS: 104227-87-4
Concentration: 99%+ for active pharmaceutical ingredient
Impurities: Typically less than 1%, related process and degradation products
Additives: None present in bulk API form
Relevant Exposure Limits: Occupational limits not established specifically for this compound; handle using pharmaceutical-grade controls
Inhalation: Move person to fresh air immediately, monitor for any coughing or shortness of breath, seek medical attention if symptoms persist
Skin Contact: Wash affected area thoroughly with soap and water, remove contaminated clothing, consult physician if irritation develops
Eye Contact: Rinse immediately with plenty of clean water—keep eyelids open for a minimum of 15 minutes, obtain medical advice if irritation occurs
Ingestion: Rinse mouth, drink water if conscious, avoid vomiting unless directed by medical personnel, contact doctor or poison center
Notes to Physician: Treat symptoms, no antidote identified, supportive management for accidental overdose or exposure
Suitable Extinguishing Media: Use water spray, carbon dioxide, dry chemical or foam
Hazardous Decomposition: Emits carbon oxides, nitrogen oxides, possibly toxic vapors if exposed to extreme heat or flame
Specific Hazards: Powder can disperse and form dust clouds, risk of dust explosion is minimal under normal pharmaceutical handling
Protective Equipment for Firefighters: Wear full protective gear including self-contained breathing apparatus, avoid exposure to combustion products
Special Procedures: Cool exposed containers with water, stay upwind of smoke and fumes, prevent runoff from fire control from entering drains or waterways
Personal Precautions: Don personal protective equipment—gloves, goggles, laboratory coat, avoid raising dust, ventilate area
Cleanup Methods: Sweep up using vacuum with HEPA filtration or moist absorbent pads, place in sealable container for disposal, decontaminate affected surfaces
Emergency Procedures: Restrict access to spill area, prevent further spread by containing powder, notify EHS officer or supervisor
Environmental Precautions: Avoid release into drains, soil, or waterways, collect all material for proper disposal
Handling: Handle within a chemical fume hood or local exhaust area, use gloves and goggles, minimize dust formation, avoid contact with skin and eyes, observe good industrial hygiene practices
Storage: Store in tightly closed original container at controlled room temperature (15–25°C), away from moisture, direct sunlight, incompatible chemicals (such as strong oxidizers and acids)
Incompatible Materials: Avoid exposure to strong acids, alkalis, and oxidizing agents, which can degrade active compound
Special Precautions: Keep away from food, drink, and animal feed, restrict unauthorized access to storage area
Engineering Controls: Work in a well-ventilated area, use local exhaust ventilation or biological safety cabinet for operations generating dust
Personal Protective Equipment (PPE): Wear approved respiratory protection in presence of powder, use chemical-resistant gloves (nitrile, latex), safety goggles, lab coat, and closed footwear
Hygiene Measures: Wash hands thoroughly after handling, remove contaminated clothing before entering eating or communal areas, do not touch face during handling
Exposure Limits: No official occupational exposure limits, handle following ALARA (as low as reasonably achievable) principles for pharmaceuticals
Physical State: Solid
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not established
pH: Slightly acidic to neutral aqueous solution
Melting Point: About 102–107°C
Boiling Point: Not applicable (decomposes before boiling)
Flash Point: Not flammable
Solubility: Sparingly soluble in water, soluble in methanol and ethanol
Partition Coefficient (log P): -0.15 (approx.)
Vapor Pressure: Negligible
Relative Density: About 1.4 g/cm³
Evaporation Rate: Not applicable
Viscosity: Not applicable
Chemical Stability: Stable under recommended storage conditions, no polymerization hazard
Conditions to Avoid: Excessive heat, direct sunlight, moisture, contact with incompatible substances
Incompatible Materials: Strong acids, oxidizers, alkalis
Hazardous Decomposition: Generates carbon oxides, nitrogen oxides, and possibly toxic fumes on thermal decomposition
Reactivity: Low under normal pharmaceutical workroom conditions, not prone to hazardous reactions
Likely Routes of Exposure: Inhalation, skin absorption, eye contact, ingestion
Acute Toxicity: LD50 (oral, rat) higher than 5000 mg/kg (low toxicity)
Skin Corrosion/Irritation: Not considered corrosive, possible mild irritation with prolonged or repeated contact
Eye Damage/Irritation: May cause mild, reversible irritation
Respiratory Sensitization: No known sensitizing potential
Skin Sensitization: Rare cases of rash or allergic reaction observed in therapeutic use
Carcinogenicity: No evidence of carcinogenicity in chronic animal studies
Reproductive/Developmental Effects: No teratogenic effects identified in animal models at high doses, effects in humans not extensively studied
Target Organ Toxicity: None known at occupational exposure levels
Symptoms of Exposure: Headache, mild gastrointestinal upset, rare cases of rash
Ecotoxicity: Low acute toxicity to aquatic life (fish, daphnia, algae)
Persistence and Degradability: Not readily biodegradable, slowly degrades in the environment
Bioaccumulative Potential: Low, based on molecular characteristics and partition coefficient
Mobility in Soil: Moderate mobility; may leach to groundwater in granular or powder spillage
Aquatic Release: Avoid uncontrolled discharges into surface water
Environmental Fate: Breakdown products minimally toxic, main component expected to dilute and degrade slowly
Disposal Methods: Dispose of contents/container in accordance with local, regional, and national regulations—incineration preferred for pharmaceuticals
Packaging Disposal: Triple rinse and treat packaging as contaminated waste, send to licensed pharmaceutical waste contractor
Special Precautions: Do not allow product to reach sewage system, surface water, or soil
Unused Product: Return for reuse or incineration via approved waste management providers
UN Number: Not classified under any transport hazard class by UN regulations
UN Proper Shipping Name: Not assigned, not dangerous for transport
Transport Hazard Class: Not regulated
Packing Group: Not regulated
Environmental Hazards: Not considered marine pollutant
Special Precautions for Transport: Prevent damage to containers, keep away from food products, transport in closed packaging
Inventory Listing: Famciclovir included in chemical substance inventories in major jurisdictions (US, EU, Canada, Australia)
OSHA Status: No specific listing as hazardous, use pharmaceutical handling controls
TSCA (US): Exempt as active pharmaceutical ingredient
REACH (EU): Monitored under pharmaceutical product regulations
Other Regulatory Status: Product subject to drug approval authorities (FDA, EMA, TGA, etc.) for use in medications
Worker Protection Laws: Comply with pharmaceutical workplace standards, local occupational safety agencies
Labeling Requirements: Standard pharmaceutical labeling required, health hazard information must be provided to workers
