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Material Safety Data Sheet (MSDS) for Amphotericin B: Must Be Refrigerated at 2-8℃

Identification

Product Name: Amphotericin B
Synonyms: Fungizone, AmBisome
CAS Number: 1397-89-3
Recommended Use: Antifungal pharmaceutical ingredient
Supplier: Pharmaceutical distributor or manufacturer’s details listed on packaging
Emergency Contact: Hazardous materials emergency line provided with shipment or product documentation

Hazard Identification

Hazard Classification: Acute toxicity (oral, dermal, inhalation), Eye irritation, Skin sensitization
Signal Word: Warning
Hazard Statements: Harmful if swallowed, Causes serious eye irritation, May cause allergic skin reaction
Pictograms: Exclamation mark, health hazard symbol
Precautionary Statements: Avoid contact with skin and eyes, Wash hands after handling, Do not eat, drink, or smoke when using this product

Composition / Information on Ingredients

Chemical Name: Amphotericin B
CAS Number: 1397-89-3
Concentration: 96-102%, depending on batch and manufacturer
Other Ingredients: May contain sodium deoxycholate or lipid formulations as stabilizers in certain products

First Aid Measures

Inhalation: Move to fresh air, monitor for respiratory difficulties, seek medical attention if symptoms persist
Skin Contact: Remove contaminated clothing, wash skin with plenty of water and mild soap, seek medical advice if rash or irritation develops
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present, continue rinsing, consult a doctor if irritation remains
Ingestion: Rinse mouth, do not induce vomiting, seek immediate medical attention, provide product label or MSDS to health care professional

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical powder, carbon dioxide, water spray, foam
Specific Hazards: May emit toxic fumes of carbon oxides and nitrogen oxides under fire conditions
Protective Equipment: Firefighters should use self-contained breathing apparatus and chemical-resistant clothing
Special Procedures: Move containers away from fire if safe, apply water to cool adjacent containers, prevent runoff from contaminating water supplies

Accidental Release Measures

Personal Precautions: Wear suitable protective gear including gloves and eye protection
Ventilation: Ensure good air circulation at spill site
Methods for Clean-Up: Sweep up carefully to avoid dust, use damp cloth to wipe residues, place collected material in labeled waste container
Environmental Precautions: Prevent spills from reaching drains or water sources, notify environmental authorities if contamination occurs

Handling and Storage

Safe Handling: Avoid generating dust, keep container tightly closed, use only in well-ventilated locations
Storage Conditions: Refrigerate at 2-8℃ in original container, protect from light and moisture, label storage area for hazardous substances
Incompatible Materials: Strong acids, strong bases, oxidizing agents
Specific Requirements: Store separate from food and incompatible compounds, restrict access to trained personnel

Exposure Controls and Personal Protection

Engineering Controls: Chemical fume hoods or local exhaust systems minimize dust exposure
Respiratory Protection: Use NIOSH-approved respirator if dust or aerosols are generated
Hand Protection: Nitrile or latex gloves recommended
Eye Protection: Safety glasses or chemical splash goggles
Skin Protection: Lab coat, protective sleeves, closed-toe footwear
Hygiene Measures: Wash hands thoroughly after handling, do not eat or drink during use

Physical and Chemical Properties

Appearance: Yellow to orange, crystalline powder
Odor: Odorless or faintly musty
pH (suspension): 10-11 in deoxycholate solution, varies in lipid preparations
Melting Point: Decomposes before melting
Solubility: Sparingly soluble in water, soluble in dimethyl sulfoxide and methanol
Boiling Point: Not applicable (decomposes)
Vapor Pressure: Not determined
Partition Coefficient (log Kow): Not available
Specific Gravity: Not determined

Stability and Reactivity

Chemical Stability: Stable under recommended storage temperatures and light-protected conditions
Decomposition Products: Toxic gases such as carbon oxides and nitrogen oxides
Reactivity: Can react with strong bases, strong acids, and oxidizers
Conditions to Avoid: Prolonged exposure to light, excessive heat, incompatible chemicals
Polymerization: Will not occur

Toxicological Information

Acute Toxicity: Oral toxicity LD50 (mouse) approx. 2 mg/kg; significant toxic effects observed in clinical and experimental settings
Skin Irritation: Possible sensitizer, rashes reported after dermal contact
Eye Effects: Severe irritation and potential tissue damage
Chronic Effects: Prolonged exposure may cause allergy, nephrotoxicity, hepatotoxicity in laboratory studies
Carcinogenicity: Not classified as carcinogenic, based on available studies
Mutagenicity: No reliable evidence for mutagenic action
Reproductive Toxicity: Evidence in animal models at high exposures; use limited to life-threatening fungal infection treatment in humans

Ecological Information

Aquatic Toxicity: Hazardous to aquatic organisms, can cause adverse effects in water environments
Persistence and Degradability: Not readily biodegradable
Bioaccumulative Potential: Potential to bioaccumulate has not been fully characterized
Mobility in Soil: Limited mobility due to low solubility
Other Adverse Effects: Wastewater treatment and effluent management protocols required to avoid environmental release

Disposal Considerations

Disposal Method: Incineration preferred for pharmaceutical waste, observe local regulations for hazardous materials disposal
Product Waste: Collect in sealed, labeled hazardous waste container
Contaminated Packaging: Dispose of in accordance with medical or chemical waste guidance
Special Precautions: Avoid contamination of surface water, ground water, and soil; coordinate with licensed waste disposal contractor

Transport Information

UN Number: 2811 (toxic solid, organic, n.o.s.)
Proper Shipping Name: Amphotericin B, solid
Transport Hazard Class: 6.1 (toxic substances)
Packing Group: III
Label: Toxic
Special Precautions: Keep refrigerated during transport, use cold packs as required, prevent container damage and leaks, comply with IATA and IMDG codes for pharmaceuticals

Regulatory Information

US OSHA: Listed as hazardous in laboratory use
TSCA: Not listed for non-industrial applications
EU Classification: Acute Tox. 4, Eye Irrit. 2, Skin Sens. 1, H302, H319, H317
Inventory Listing: Registered drug product under FDA for clinical use
Workplace Exposure Limits: No official occupational exposure limit; recommended monitoring of symptoms and clinical effects in healthcare workers
Other Regulations: Controlled transport and storage conditions specified for regulated distribution, safety training required for personnel