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Material Safety Data Sheet for Gentamicin Sulfate - BP2002 Standard

Identification

Product Name: Gentamicin Sulfate
Synonyms: Gentamicin Monosulfate, Gentamycin Sulfate
CAS Number: 1405-41-0
Recommended Use: Pharmaceutical raw material, treatment of bacterial infections
Supplier: Pharmaceutical supplier or laboratory
Emergency Telephone: Local poison control center or supplier’s emergency line

Hazard Identification

Classification: Not classified as hazardous under GHS for general laboratory use, but can cause health effects after prolonged exposure
Routes of Exposure: Inhalation, ingestion, skin contact, eye contact
Health Hazards: May affect kidneys, may cause allergic skin reactions; inhaling dust may irritate respiratory tract
Environmental Hazards: May be harmful to aquatic life with long-lasting effects
Signal Word: Caution
Pictograms: None required under normal handling, but recommended for laboratory safety
Precautionary Statements: Avoid breathing dust; wash hands thoroughly after handling; use only outdoors or in a well-ventilated area

Composition / Information on Ingredients

Chemical Identity: Gentamicin Sulfate
Component: Gentamicin base as sulfate salt
Purity: Usually >95%, impurities as per BP2002 monograph
Molecular Formula: C21H43N5O7 · H2SO4
Molecular Weight: Approx 575–600 g/mol (depends on hydration form)

First Aid Measures

Eye Contact: Rinse thoroughly with plenty of water for at least 15 minutes, seek medical advice if irritation persists
Skin Contact: Remove contaminated clothing, wash skin with soap and water, medical attention if skin reaction occurs
Inhalation: Move to fresh air, keep at rest, seek medical attention if unwell
Ingestion: Rinse mouth, drink water, do not induce vomiting unless directed by medical personnel, get medical help promptly
Most Important Symptoms: Allergic skin reaction, irritation, headache, difficulty breathing in hypersensitive individuals

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, foam
Unsuitable Extinguishing Media: Never use direct water jet; risk of chemical runoff
Hazardous Combustion Products: Carbon oxides, nitrogen oxides, sulfur oxides, toxic fumes
Protective Equipment: Firefighters should wear full protective gear and a self-contained breathing apparatus
Special Procedures: Contain runoff, ventilate area after fire is extinguished

Accidental Release Measures

Personal Precautions: Wear suitable protective clothing, gloves, safety glasses, and dust mask
Environmental Precautions: Prevent further leakage or spillage; do not allow into sewers, drains, or watercourses
Spill Cleanup Methods: Scoop up without generating dust, place in suitable container for proper disposal, clean affected area with water and detergent
Reference to Other Sections: Refer to handling and disposal instructions for additional details

Handling and Storage

Handling: Work in well-ventilated areas, avoid creating and inhaling dust, use local exhaust ventilation, avoid contact with eyes and skin, wash hands after handling
Storage Conditions: Store in a cool, dry, well-ventilated location, keep container tightly closed, protect from light and moisture
Incompatible Materials: Strong oxidizers, acids
Hygienic Practices: Wash hands and face after handling, do not eat or drink in work area

Exposure Controls and Personal Protection

Exposure Limits: No occupational exposure limits established for gentamicin sulfate as a bulk pharmaceutical; minimize exposure
Engineering Controls: Work within fume hood or with local exhaust ventilation
Personal Protective Equipment: Chemical-resistant gloves, protective goggles, lab coat, approved dust mask or N95 respirator during dusty operations
Environmental Exposure Control: Use procedures to limit environmental discharge, avoid introducing material into the environment unnecessarily

Physical and Chemical Properties

Appearance: White to off-white powder
Odor: Odorless
Solubility: Freely soluble in water, practically insoluble in ethanol and chloroform
pH (5% solution): 3.5–5.5
Melting Point: Decomposes before melting; no distinct melting point
Boiling Point: Not applicable (decomposes)
Flash Point: Not flammable
Vapor Pressure: Not applicable
Density: Not available
Partition Coefficient (log P): Not applicable for salt form

Stability and Reactivity

Chemical Stability: Stable under normal conditions, sensitive to excessive heat, light, and moisture
Reactivity: Low reactivity under recommended storage and handling
Possibility of Hazardous Reactions: No polymerization, stable under proper conditions
Incompatible Materials: Strong oxidizers, acids
Decomposition Products: Toxic fumes including nitrogen and sulfur oxides upon heating to decomposition

Toxicological Information

Acute Toxicity: Data in animals show LD50 (oral, rat) at 6600 mg/kg; considered low toxicity by oral route
Chronic Effects: Risk of nephrotoxicity and ototoxicity with prolonged exposure; can cause skin sensitization
Inhalation Exposure: May cause respiratory tract irritation and allergic symptoms in susceptible persons
Skin and Eye Contact: May cause redness, itching, irritation; repeated or prolonged contact increases risk
Carcinogenicity: No evidence suggests carcinogenic potential
Other Effects: Possible cross-sensitization with other aminoglycosides

Ecological Information

Ecotoxicity: Harmful to aquatic organisms at high concentrations, long-term environmental effects possible
Mobility in Soil: Expected to be mobile in soil due to high water solubility
Persistence and Degradability: Not rapidly biodegradable, may persist in environment
Bioaccumulative Potential: Low potential for bioaccumulation
Other Adverse Effects: Residual pharmaceutical activity may contribute to antimicrobial resistance if not properly controlled

Disposal Considerations

Waste Disposal Methods: Collect and place in tightly sealed containers for proper disposal through authorized chemical waste disposal contractor
Contaminated Packaging: Dispose of in accordance with local and national regulations; packaging can contain product residues
Additional Recommendations: Avoid disposal in drains, water sources, or general refuse; follow applicable environmental protection regulations

Transport Information

UN Number: Not regulated for transport under UN, IATA, or IMDG codes
Hazard Class: Not classed as hazardous material
Packing Group: Not assigned
Special Precautions: Ensure packaging is secure, avoid generation of dust in transit, prevent container breakage
Environmental Hazards: Not classified as marine pollutant, but take care to prevent release during shipments

Regulatory Information

Labelling Requirements: Substance not subject to specific labeling under EU CLP or US OSHA Hazcom for laboratory-scale use, but handle according to good industrial hygiene and safety practice
Inventory Status: Listed on EU EINECS/ELINCS, US TSCA, Australia AICS, Canada DSL/NDSL
Regulatory Restrictions: Pharmaceutical use restricted to licensed professionals, subject to prescription control
Other Regulations: Subject to environmental and pharmaceutical regulations regarding waste, emissions, and antimicrobial stewardship