Product Name: Zoledronic Acid
Chemical Name: (1-Hydroxy-2-(1H-imidazol-1-yl)ethylidene)bisphosphonic acid
Synonyms: Zoledronate, Zometa, Reclast
CAS Number: 118072-93-8
Recommended Use: Pharmaceutical agent for the treatment of bone diseases such as osteoporosis and hypercalcemia of malignancy
Manufacturer: Novartis Pharmaceuticals Corporation or respective pharmaceutical supplier
Emergency Contact: Use local or national poison control center and medical response hotlines
Contact Information: Product Safety Department, pharmaceutical company office details as per supplier
GHS Classification: Acute Toxicity (Oral) Category 4, Eye Irritation Category 2A, Skin Sensitization Category 1
Signal Word: Warning
Hazard Statements: Harmful if swallowed, causes serious eye irritation, may cause allergic skin reaction
Pictograms: Exclamation mark
Precautionary Statements: Wear protective gloves/eye protection, wash hands thoroughly after handling, avoid breathing dust or fumes, in case of inadequate ventilation use respiratory protection
Route of Exposure: Inhalation, ingestion, skin and eye contact
Potential Health Effects: May cause nausea, vomiting, abdominal pain, eye redness, skin rash, respiratory symptoms if inhaled
Chemical: Zoledronic Acid
Concentration: Pure substance or as finished pharmaceutical preparation (typical intravenous concentration: 4 mg/5 mL solution)
Molecular Formula: C5H10N2O7P2
Molecular Weight: 272.09 g/mol
Main Hazardous Components: Zoledronic Acid (100% for raw ingredient), diluted in sterile water or saline for clinical use
Impurities: Trace manufacturing and synthesis byproducts within pharmaceutical grade specifications
Inhalation: Move to fresh air, monitor breathing, provide artificial respiration if not breathing, seek immediate medical attention
Skin Contact: Remove contaminated clothing, wash skin thoroughly with soap and water, seek medical help if irritation develops
Eye Contact: Rinse cautiously with water for at least 15 minutes, remove contact lenses if present and easy to do, seek medical evaluation
Ingestion: Rinse mouth, do not induce vomiting, give water to dilute, seek medical attention immediately
Most Important Symptoms: Nausea, abdominal pain, vomiting, skin rash, eye irritation, allergic reactions
Medical Attention Needed: Always seek professional medical evaluation after significant exposure, monitor symptoms
Suitable Extinguishing Media: Water spray, carbon dioxide (CO2), dry chemical, foam
Unsuitable Extinguishing Media: None known for finished product, avoid direct water stream on chemical fires
Fire and Explosion Hazards: Non-flammable, may release toxic fumes under fire conditions (nitrogen oxides, phosphorus oxides, carbon oxides)
Protective Equipment: Wear self-contained breathing apparatus and full protective gear, prevent contamination of drainage
Specific Hazards: Avoid inhalation of combustion products, prevent runoff to waterways, handle firefighting water as hazardous waste
Firefighting Instructions: Evacuate area, fight fire from safe distance, use water spray to cool containers
Personal Precautions: Avoid dust, direct contact with skin and eyes, ventilate area, use appropriate personal protective equipment
Environmental Precautions: Prevent material from entering drains or watercourses, contain spill to prevent dispersion
Clean-Up Procedures: Absorb liquid with inert material like vermiculite, collect spillage in suitable containers for disposal, clean area with plenty of water
Disposal: Dispose of in accordance with local, regional, and national regulations, use licensed waste disposal contractor
Decontamination: Wash affected area with soap and water following spill removal, ventilate area until thoroughly clean
Reporting Requirements: Notify relevant environmental authorities if significant quantities escape into the environment
Handling: Use in well-ventilated areas, avoid inhalation or contact with eyes, wear protective clothing and gloves, do not eat, drink, or smoke when handling
Storage Conditions: Store in original container tightly closed in a cool, dry, and well-ventilated place, avoid freezing or excessive heat
Incompatibilities: Strong bases, strong acids, oxidizing agents, avoid exposure to reactive chemicals
Storage Temperature: 2–8°C (refrigerated storage for most pharmaceutical preparations), keep away from direct sunlight
Special Instructions: Keep container upright to prevent leaks, protect from physical damage, follow specific pharmacy or manufacturer recommendations
Exposure Limits: No established occupational exposure limits for Zoledronic Acid, minimize exposure as much as possible
Engineering Controls: Use local exhaust ventilation and general room ventilation to control airborne exposures, use closed-system transfers when possible
Personal Protection: Wear chemical-resistant gloves (nitrile or latex), safety goggles, laboratory coat, face shield if risk of splashing
Respiratory Protection: Use NIOSH-approved respirator if airborne dust or aerosols present, especially during bulk handling
Hygiene Measures: Wash hands after handling, remove and wash contaminated clothing before reuse, avoid touching face or exposed skin
Monitoring: Implement regular workplace air monitoring if significant dust or vapor expected during use
Appearance: White to off-white crystalline powder (bulk), clear colorless solution (medication formulation)
Odor: Odorless
Odor Threshold: Not applicable
pH: Approximately 6.0 (for 4 mg/5 mL solution)
Melting Point/Freezing Point: Decomposes above 235°C (bulk powder)
Boiling Point: Not applicable (decomposes)
Solubility: Highly soluble in water, insoluble in organic solvents
Vapor Pressure: Negligible
Partition Coefficient (log Pow): -3.43 (very hydrophilic)
Evaporation Rate: Not applicable
Density: 2.059 g/cm³ (bulk)
Flash Point: Not flammable
Explosive Properties: Not expected to form explosive mixtures
Chemical Stability: Stable under recommended storage conditions, sensitive to extremes of temperature and pH
Incompatible Materials: Strong acids, strong bases, oxidizers, metal ions
Hazardous Reactions: No hazardous polymerization expected, reacts exothermically with strong acids and bases
Decomposition Products: Nitrogen oxides, phosphorus oxides, carbon oxides under thermal decomposition
Conditions to Avoid: Extreme heat, freezing, direct sunlight, moisture ingress
Reactivity: Low under ambient conditions in pharmaceutical setting
Plausible Exposure Routes: Inhalation, ingestion, dermal, ocular
Acute Toxicity: LD50 (rat, oral): approximately 50 mg/kg, may cause gastrointestinal distress, hypocalcemia
Skin Corrosion/Irritation: Mildly irritating to skin
Eye Damage/Irritation: Can cause serious eye irritation and redness
Respiratory Sensitization: Risk of asthma-like symptoms after inhalation exposure
Skin Sensitization: Can cause allergic dermatitis or rash in sensitive individuals
Mutagenicity/Carcinogenicity: No evidence of mutagenic or carcinogenic potential in standard animal studies
Chronic Toxicity: Prolonged exposure may disturb calcium metabolism, kidney function
Target Organs: Kidneys, gastrointestinal tract, skin, eyes
Symptoms: Nausea, vomiting, diarrhea, abdominal pain, rash, muscle cramps, fever
Ecotoxicity: Harmful to aquatic life due to high water solubility and persistence in the environment
Aquatic Toxicity: LC50 (fish, Oryzias latipes): 33 mg/L/96h
Persistence and Degradability: Poorly biodegradable, tends to persist in soil and water
Bioaccumulative Potential: Does not bioaccumulate (low octanol-water partition), rapidly distributed in water
Mobility in Soil: High mobility, risk of leaching into groundwater
Other Adverse Effects: Potential hazard to microorganisms in wastewater treatment, follow pharmaceutical waste management guidelines
Regulatory Reference: Not listed as a marine pollutant but classified as environmentally hazardous by many agencies
Waste Treatment Methods: Dispose of as hazardous pharmaceutical waste, use incineration or secure landfill according to regulations
Contaminated Packaging: Treat any packaging that has come in contact as hazardous, triple rinse, dispose following pharmaceutical waste protocols
Disposal Prohibitions: Do not dispose in household garbage, municipal drains or watercourses
Special Precautions: Work with licensed disposal providers, retain records of disposal and transfer, prevent unauthorized access
Regulatory Compliance: Follow all applicable state, national, and regional regulations for hazardous wastes
UN Number: Not classified as dangerous goods for transport by IMDG, IATA, or ADR
UN Proper Shipping Name: Not regulated
Transport Hazard Classes: Not applicable
Packing Group: Not applicable
Marine Pollutant: No classification as marine pollutant but environmental precautions recommended
Special Precautions: Use secure, leak-proof containers during transport, label secondary packaging, ensure all documentation accompanies shipment
Transport Label Requirements: General pharmaceutical handling labels if not regulated
OSHA Status: Considered hazardous as per OSHA Hazard Communication Standard
TSCA Status: Not listed on the United States Toxic Substances Control Act (TSCA) inventory
EU Classification: Xi (Irritant), R36/38 (Irritating to eyes and skin), S26 (In case of contact with eyes, rinse immediately with plenty of water and seek medical advice)
REACH Registration: Exempt as finished pharmaceutical product
Other Global Inventories: Not generally listed as bulk chemical, controlled as pharmaceutical substance
Regulatory Controls: Subject to prescription drug regulations, occupational hazard measures in workplace, pharmaceutical waste rules
Labeling Requirements: Conforms to local health and safety requirements, includes hazard statements and precautionary advice
