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Product Name: Amikacin Sulfate
Chemical Formula: C22H43N5O13 · 2H2SO4
Synonyms: Amikacin, Amikacin Sulfate USP, Amikacin Monosulfate Hemisulfate Salt
CAS Number: 39831-55-5
Manufacturer: Major bulk pharmaceutical manufacturers, global and regional
Recommended Use: Antibiotic for health care, research, and compounding
Emergency Phone: Refer to local, regional, or facility-specific emergency numbers
Supplier Address: Supply chain points, including location-specific addresses
Classification: Not classified as a hazardous substance under GHS criteria
Signal Word: None required
Hazard Statements: May cause allergic skin reactions and eye irritation in sensitive individuals
Pictograms: Exclamation mark for skin or eye irritation
Precautionary Statements: Avoid breathing dust and powder; wash thoroughly after handling; use only in well-ventilated areas
Potential Health Effects: Inhalation or skin exposure can trigger allergic responses
Chronic Effects: Long-term contact may affect the kidneys and auditory nerves
Target Organs: Kidneys and ears
Chemical Name: Amikacin Sulfate
Concentration: ≥98% active ingredient by weight
Impurities: Trace amounts of process-related impurities; minimal inactive ingredients
Other Ingredients: Excipients not typically present in raw bulk material, check formulation if compounded
Inhalation: Move to fresh air; seek medical attention if symptoms arise such as coughing or difficulty breathing
Skin Contact: Remove contaminated clothing; wash with soap and water for at least 15 minutes; observe for irritation, seek medical advice for allergic responses
Eye Contact: Rinse immediately with clean flowing water for 10 minutes; consult physician if redness or pain persists
Ingestion: Rinse mouth; do not induce vomiting; seek medical advice, especially in case of large ingestion or if patient is symptomatic
Most Important Symptoms: Allergic dermatitis, rash, mild respiratory irritation, ocular redness
Notes for Physician: Treat symptomatically and monitor renal and hearing functions if exposure is significant
Suitable Extinguishing Media: Use water spray, dry chemical, or carbon dioxide; select media suitable for surrounding fire
Specific Hazards: Heating may release irritating or toxic vapors such as nitrogen oxides, sulfur oxides
Special Protective Equipment: Firefighters require self-contained breathing apparatus and full protective clothing
Thermal Decomposition Products: Toxic fumes expected; avoid direct exposure to combustion gases
Precautions: Keep containers cool by spraying with water; minimize dust generation and inhalation
Personal Precautions: Avoid dust formation; use protective gloves, eye protection, and NIOSH-approved respirator
Environmental Precautions: Prevent spill from reaching waterways, drains, or soil; contain with inert absorbent
Cleanup Methods: Sweep or vacuum spilled solute using non-sparking tools; place material in closed labeled containers for proper disposal
Decontamination: Wash area thoroughly with water and detergent; ventilate affected area
Handling: Handle with care using proper PPE to prevent skin, eye, and respiratory exposure; avoid dust generation
Storage: Store in tightly closed containers, away from moisture, heat, and incompatible substances like strong oxidizers
Temperature: Keep at controlled temperatures (15-30°C), protected from light and humidity
Special Requirements: Limit access to authorized, trained personnel; maintain clean workspaces
Engineering Controls: Use local exhaust ventilation in weighing, compounding, or dispensing areas
Personal Protection: Chemical-resistant gloves (nitrile, latex), protective eyewear (goggles), laboratory coat, and NIOSH-approved respirator during powder handling
Hygiene Measures: Wash hands and exposed skin areas before breaks and after work; avoid eating or drinking near material
Occupational Exposure Limits: Not established for amikacin sulfate; standard nuisance dust limit (total and respirable) recommended
Appearance: White to off-white powder or crystalline substance
Odor: Odorless
Odor Threshold: Not applicable
pH: Aqueous solution ranges from 4.5 to 6.0
Melting Point: Decomposes before melting
Boiling Point/Range: Not defined (decomposes)
Flash Point: Not applicable
Flammability: Non-flammable solid
Vapor Pressure: Negligible
Solubility: Freely soluble in water, almost insoluble in organic solvents
Partition Coefficient (log Kow): Data not available
Auto-ignition Temperature: Not self-igniting
Decomposition Temperature: Data limited, breakdown above 200°C
Viscosity: Not relevant (solid)
Chemical Stability: Stable under recommended storage conditions
Conditions to Avoid: Excess heat, exposure to light, elevated humidity, strong oxidizing agents
Reactivity: No dangerous reactions known under normal conditions
Hazardous Decomposition Products: Nitrogen oxides, sulfur oxides, carbon dioxide on burning
Incompatibilities: Strong acids and bases, powerful oxidizers
Acute Toxicity: LD50 (oral, rat) >2,000 mg/kg; low acute toxicity in healthy subjects
Skin Corrosion/Irritation: May induce mild irritation, possible allergic dermatitis in sensitized individuals
Serious Eye Damage/Irritation: May cause moderate irritation
Respiratory Sensitization: Allergic reactions possible; clinical exposure linked to bronchial irritation
Germ Cell Mutagenicity: No mutagenic effects observed in bacterial or animal studies
Carcinogenicity: Not classed as a carcinogen by IARC, NTP, OSHA
Reproductive Toxicity: Data insufficient for reproductive harm in humans; animal data suggest risk at high doses
Specific Target Organ Toxicity: High-dose or clinical misuse tied to ototoxicity, nephrotoxicity
Symptoms: Redness, rash, hearing loss, balance disruption, kidney impairment
Ecotoxicity: Antibiotic action can disrupt aquatic microbial life; low concentrations toxic to some fish and daphnia
Persistence and Degradability: Moderately biodegradable; breakdown products less bioactive
Bioaccumulative Potential: Low—very little tendency to accumulate in organisms
Mobility in Soil: High solubility in water allows possible migration in surface water
Other Adverse Effects: Wastewater contamination can influence environmental bacteria and promote antibiotic resistance; no ozone depletion expected
Waste Treatment: Incinerate in an approved chemical incinerator or dispose of in compliance with local regulations
Contaminated Packaging: Dispose of as hazardous pharmaceutical waste; triple rinse and deface containers before recycling or landfilling
Environmental Precautions: Prevent widespread environmental release; avoid large-volume landfill disposal
Special Disposal Notes: Do not discharge undiluted or large volumes to municipal sewers
UN Number: Not assigned for Amikacin Sulfate in bulk powder
Proper Shipping Name: Not classified as dangerous for air, sea, or road transport according to UN Model Regulations
Transport Hazard Class: Not regulated
Packing Group: Not applicable
Environmental Hazards: Not considered marine pollutant; avoid bulk discharge
Special Precautions: Protect from heat and moisture during transport; keep containers tightly sealed
OSHA: Not regulated as a hazardous chemical
TSCA: Not listed, prescription-use material
SARA Title III: Not subject to emergency planning and notification
California Proposition 65: Not listed
WHMIS (Canada): Exempt for prescription drugs; workplace controls apply
EU REACH: Substance is subject to pharmaceutical regulation; not specifically classified
Other International Listings: Subject to regulatory controls in most jurisdictions as a prescription active compound
