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Product Name: Fosfomycin Tromethamine/Fumex Tromethamine
Chemical Name: Phosphonic acid, (1R,2S)-1,2-epoxypropyl-, 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)
Synonyms: Monurol, Fosfomycin trometamol
Recommended Use: Pharmaceutical antibacterial agent
Manufacturer Name: [Confidential Supplier/Manufacturer Name]
Address: [Confidential Company Address]
Emergency Phone: [Local Emergency Contact]
Email: [Support Email]
CAS Number: 78964-85-9
Classification: Not classified as hazardous by GHS standards for pharmaceutical use
Signal Word: None
Hazard Statements: May cause eye, skin, or respiratory irritation; overexposure may trigger allergic reactions in sensitive individuals
Pictogram: No symbol required by regulation
Precautionary Statements: Avoid inhalation and contact with eyes, skin, and clothing; wash hands after handling; use appropriate protective equipment
Chemical Identity: Fosfomycin Tromethamine
CAS Number: 78964-85-9
Content: 98-100% pure
Impurities: Residual solvents (if present), unreacted starting materials, water
Molecular Formula: C7H18NO7P
Molecular Weight: 259.2 g/mol
Eye Contact: Flush with water for 15 minutes; seek medical attention if irritation persists
Skin Contact: Wash with plenty of soap and water; remove contaminated clothing
Inhalation: Move to fresh air; provide oxygen or artificial respiration if breathing is difficult
Ingestion: Never give anything by mouth to an unconscious person; rinse mouth with water; seek medical attention if symptoms occur
Most Important Symptoms: Redness, irritation, allergic response, difficulty breathing in severe cases
Suitable Extinguishing Media: Water spray, CO2, dry chemical, foam
Unsuitable Media: Strong water jets could spread dust
Fire Hazards: Not flammable; combustible dust may form in finely divided state
Specific Hazards: Phosphorus oxides, nitrogen oxides may form upon thermal decomposition
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and full protective gear
Additional Information: Prevent contamination of drains; control runoff from fire control or dilution
Personal Precautions: Use personal protection, including gloves, goggles, dust mask
Environmental Precautions: Prevent entry into sewers, soil, surface water; avoid generating dust
Methods for Cleanup: Sweep or vacuum using dust collector; avoid dry sweeping if possible; place in closed containers for disposal
Spill Reporting: Notify supervisor if spill occurs in work area; follow local disposal regulations
Handling: Handle in well-ventilated area; avoid inhaling dust or vapors; avoid skin and eye contact; do not eat, drink, or smoke while using
Storage Conditions: Store in original, tightly closed container in a cool, dry, well-ventilated place; keep away from incompatible materials (strong oxidizers, acids)
Special Requirements: Keep out of reach of children; maintain temperature between 2-25°C; protect from light and humidity
Incompatible Materials: Avoid storing near strong oxidants and acids; moisture can degrade product
Exposure Limits: No occupational exposure limits established for active ingredient; use threshold limits for nuisance dust (ACGIH TLV for particulates not otherwise classified: 10 mg/m³ total dust, 3 mg/m³ respirable fraction)
Engineering Controls: Work in areas with adequate ventilation; use local exhaust or dust extraction; safety shower and eye wash station recommended
Personal Protection: Nitrile gloves, chemical safety goggles, laboratory coat; NIOSH-approved respirator if dust exposure possible
Hygiene Measures: Wash hands, forearms, and face after handling; remove contaminated clothing and wash before reuse
Appearance: White to off-white, crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH (solution): 7-8 (in aqueous solution, 1% w/v)
Melting Point: Decomposes before melting, above 140°C
Boiling Point: Not applicable (decomposes)
Flash Point: Not applicable
Flammability: Not classified as flammable
Vapor Pressure: Not applicable
Solubility: Highly soluble in water (approx. 500 mg/mL)
Density: ~1.6 g/cm³
Partition Coefficient (n-octanol/water): Not available
Decomposition Temperature: Above 140°C
Evaporation Rate: Not applicable
Chemical Stability: Stable under recommended storage conditions
Reactivity: No hazardous reactions expected under normal conditions of use
Conditions to Avoid: Prolonged exposure to humidity, heat, direct sunlight
Incompatible Materials: Strong oxidizers, strong acids
Hazardous Decomposition Products: Phosphorus oxides, carbon oxides, nitrogen oxides may form at high temperature
Hazardous Polymerization: Will not occur
Acute Toxicity: Low oral toxicity in animal studies (LD50 in rats > 2000 mg/kg); irritant in eyes and on skin
Chronic Toxicity: No carcinogenic or mutagenic effects observed in standard animal testing
Routes of Exposure: Inhalation, skin contact, ingestion, eye contact
Possible Effects: Irritation of eyes/skin, gastrointestinal disturbance, respiratory tract irritation; hypersensitivity reactions recorded
Sensitization: Allergic skin or respiratory response possible in sensitive individuals
Further Information: Not classified as a human carcinogen, germ cell mutagen, or reproductive toxin by IARC, NTP, OSHA
Ecotoxicity: No data on environmental toxicity specific to this compound; based on available data, not anticipated to cause acute environmental harm
Persistence and Degradability: Readily biodegradable in environmental conditions; does not bioaccumulate
Mobility in Soil: High solubility in water indicates potential for mobility in the environment
Bioaccumulative Potential: Not expected to bioaccumulate due to low log Kow
Other Adverse Effects: Uncontrolled release to the environment should be avoided due to antibiotic effects; possible impact on aquatic microbial communities
Waste Methods: Dispose of material in compliance with local, regional, and national regulations for pharmaceuticals
Unused Product: Can be incinerated or landfilled at a licensed facility
Contaminated Packaging: Triple rinse and offer for recycling or appropriate disposal
Additional Precautions: Never dispose via wastewater or municipal drains to prevent impact on environment or water treatment organisms
UN Number: Not regulated under existing transport codes
UN Proper Shipping Name: Not classified as dangerous goods
Transport Hazard Class: None
Packing Group: None
Special Precautions: Protect from moisture; ship in tightly sealed original containers
Environmental Hazards: Not classified as hazardous to environment for transport
Regulatory Status: Approved active pharmaceutical ingredient in major markets (e.g., FDA, EMA submissions)
International Listings: Listed in national chemical inventories where applicable, such as TSCA, EINECS
Labeling Requirements: Package must include appropriate hazard warnings, batch number, manufacturer, and expiry date
Other Specific Requirements: Compliance with pharmaceutical GMP and local drug regulations
Safety, Health and Environmental Regulations: OSHA Hazard Communication, WHMIS, REACH covered for safe handling guidance
