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Material Safety Data Sheet of Cefepime Hydrochloride

Identification

Product Name: Cefepime Hydrochloride
Chemical Name: (6R,7R)-7-[(2Z)-2-(2-Aminothiazol-4-yl)-2-(methoxyimino)acetamido]-3-[(1-methylpyrrolidinium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate hydrochloride
CAS Number: 123171-59-5
Recommended Use: Antibacterial agent for pharmaceutical manufacturing and clinical treatment
Distributor: Pharmaceutical suppliers, hospitals, and research labs
Emergency Contact: Poison Control Center & local emergency response numbers
Synonyms: Cefepime, Maxipime, Cefepim Hydrochloride

Hazard Identification

GHS Classification: Not classified as hazardous under GHS for most scenarios; may cause irritation to skin, eyes, and respiratory tract
Primary Hazards: Possible allergic responses in sensitized individuals; risk of microbial resistance in improper handling; dust can irritate mucous membranes
Pictograms: Exclamation mark for possible skin, respiratory, and eye irritation; health hazard pictogram for potential allergic reactions
Signal Word: Warning
Precautionary Statements: Avoid breathing dust; avoid contact with skin and eyes; wash hands after handling; use appropriate PPE
Effects of Overexposure: Nausea, vomiting, rash, allergic reaction, breathing difficulty in severe cases
Chronic Hazards: Prolonged or repeated exposure may trigger allergic dermatitis or respiratory sensitization

Composition / Information on Ingredients

Component: Cefepime Hydrochloride
CAS Number: 123171-59-5
Concentration: 98–100% in pure substance, lower in formulations
Impurities: Trace levels of starting materials, degradation products under improper storage
Inactive Ingredients: Possible buffer salts (in clinical formulations such as sodium carbonate), diluents in injectable form

First Aid Measures

Inhalation: Move the person outdoors to fresh air, offer oxygen if breathing becomes difficult, contact a physician immediately
Skin Contact: Remove contaminated clothing, wash skin with soap and plenty of water, monitor for rash or allergic symptoms, seek medical attention as needed
Eye Contact: Rinse with water for at least 15 minutes, keep eyelids open while flushing, get prompt medical evaluation
Ingestion: Rinse mouth thoroughly, do not induce vomiting unless instructed by medical personnel, give small amounts of water if patient is conscious, contact poison control center
Most Important Symptoms: Hives, difficulty breathing, swelling, rash, anaphylaxis in rare severe cases
Immediate Medical Attention: Necessary for severe allergic reactions, persistent symptoms, or accidental high-dose ingestion

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Hazardous Combustion Products: May produce toxic fumes including nitrogen oxides, sulfur oxides, and hydrogen chloride gas during thermal decomposition
Unsuitable Extinguishing Media: High-pressure water streams may spread powder and dust
Fire Fighter Protection: Wear self-contained breathing apparatus (SCBA), full protective gear, avoid inhalation of fumes
Fire and Explosion Hazards: Not flammable in solid state but can form dust clouds; avoid generating dust in closed areas

Accidental Release Measures

Spill Response: Ventilate area, use local exhaust; avoid creating dust clouds
Personal Precautions: Wear disposable gloves, safety goggles, laboratory coat or coveralls, and dust respirator
Cleanup Methods: Sweep up material using methods that minimize dust, collect in sealable containers for proper disposal
Environmental Precautions: Prevent release into drains or waterways; notify authorities if large amounts contaminated soil or water
Decontamination: Wash spill site with copious amounts of water and detergent until no residue remains

Handling and Storage

Precautions for Safe Handling: Handle in ventilated area, avoid inhalation and contact with skin and eyes, prevent dust generation, use PPE
Technical Measures: Use closed systems or local exhaust extraction, clean up spills promptly
Storage Conditions: Keep container tightly closed, store in a cool (2–8°C), dry place away from direct sunlight and incompatible substances
Incompatibilities: Strong acids, strong bases, oxidizing agents, moisture
Specific End Uses: Research and pharmaceutical production, administration to patients only by trained professionals

Exposure Controls and Personal Protection

Engineering Controls: Well-ventilated workspace; local exhaust hoods and HEPA filtration; negative pressure rooms in high-volume settings
Eye/Face Protection: Safety goggles, face shield in powder handling
Skin Protection: Nitrile or latex gloves, lab coat, possible full suit in case of large-scale operations
Respiratory Protection: N95 or higher respirators for dust creation, P3 particulate filters for bulk material cleanup
Hygiene Measures: Wash hands and forearms after handling, remove contaminated equipment, do not eat, drink, or smoke in handling areas
Exposure Limits: No OSHA or ACGIH threshold limit values established for cefepime hydrochloride
Environmental Controls: Ensure effluents containing drug residues are treated; avoid release into environment

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless or faintly medicinal
pH: 4.0–6.0 in solution
Melting Point: Decomposes at about 160°C (information based on decomposition)
Solubility: Freely soluble in water; practically insoluble in acetone, ethanol, and ether
Partition Coefficient (log Pow): Data not available, expected low due to ionic nature
Boiling Point: Not applicable (decomposes before boiling)
Vapor Pressure: Not relevant for solid forms
Density: Approx. 1.7 g/cm³
Other Data: Hygroscopic; sensitive to moisture and light, color may deepen on prolonged exposure

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions; sensitive to heat, light, and moisture
Conditions to Avoid: Extended exposure to high temperatures, strong light, and humidity
Incompatible Materials: Strong oxidizers, acids, alkalis; moisture accelerates decomposition
Hazardous Decomposition Products: Nitrogen oxides, sulfur oxides, hydrogen chloride
Polymerization: Not expected to occur under normal conditions

Toxicological Information

Acute Toxicity: Oral LD50 in rats reported >2000 mg/kg; low acute systemic toxicity
Skin/Eye Irritation: Possible mild irritation, rare reports of contact dermatitis
Respiratory Sensitization: Inhalation of powders may cause respiratory irritation, asthmatic symptoms in sensitized people
Carcinogenicity: Not listed by IARC, NTP, or OSHA as carcinogenic
Mutagenicity: No evidence of mutagenic potential in Ames tests or chromosomal aberration studies
Reproductive Toxicity: Animal studies indicate no adverse effects on reproduction at therapeutic doses; insufficient data in humans
Other Effects: High doses may provoke central nervous system symptoms, especially in renal failure patients

Ecological Information

Ecotoxicity: Antibiotic activity may pose risks to aquatic microbial populations, contributing to environmental resistance development
Persistence and Degradability: Moderate persistence; incomplete breakdown in sewage treatment can lead to trace pharmaceutical pollution
Bioaccumulative Potential: Likely low due to water solubility and ionic characteristics
Mobility in Soil: Likely mobile in aqueous environments, limited ability to adsorb to soils
Other Adverse Effects: Wider environmental release can promote selection of resistant bacterial strains in natural water bodies

Disposal Considerations

Disposal Methods: Incinerate pharmaceutical waste at high temperature in an approved facility; avoid uncontrolled disposal; follow national and regional legislation
Packaging Disposal: Empty containers must be rendered unusable prior to disposal; avoid reuse
Contaminated Waste: Treat as hazardous waste; segregate from general waste streams
Precautions: Do not flush down drains; prevent entry into surface or ground water systems

Transport Information

UN Number: Not regulated as a dangerous good for air, road, or sea transport
Proper Shipping Name: Cefepime Hydrochloride
Transport Hazard Class: None assigned
Packing Group: None
Marine Pollutant: Not a marine pollutant according to IMDG
Special Precautions: Transport in closed containers; protect from physical damage, moisture, and light; maintain temperature between 2–8°C

Regulatory Information

US Regulations: Not classified as a hazardous substance under OSHA Hazard Communication; not listed under CERCLA, RCRA, or SARA Title III
EU Regulations: Not classified as dangerous under Regulation (EC) No. 1272/2008 (CLP); restricted pharmaceutical use only
Other National Regulations: Complies with national pharmacopeias where approved; requires prescription for medical use
Workplace Regulations: Recommended use of PPE, engineering controls in place
Inventory Listings: Registered for use in drug product manufacturing; not a restricted industrial chemical