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Product Name: Cephalexin Monohydrate
Chemical Family: Beta-lactam antibiotic
Molecular Formula: C16H17N3O4S•H2O
CAS Number: 23325-78-2
Synonyms: Keflex, Ceporex, Keforal
Manufacturer Contact: Emergency hotline and technical information listed on packaging; follow local requirements for up-to-date contacts.
Intended Use: Prescription antibiotic for bacterial infections
GHS Classification: Not classified as hazardous under OSHA Hazard Communication Standard
Hazard Statements: May cause allergic reactions; can provoke respiratory sensitivity or skin rashes in susceptible individuals
Precautionary Statements: Don’t inhale dust; avoid skin or eye contact; wash hands thoroughly after handling
Potential Health Effects: Inhalation may cause respiratory irritation, skin contact could lead to sensitization, ingestion in non-therapeutic amounts may result in gastrointestinal symptoms; people allergic to penicillins or cephalosporins risk anaphylactic reactions
Active Ingredient: Cephalexin Monohydrate (≥97% purity)
Impurities: Hydration water (<1%); related organic impurities well below risk threshold
Formulation: Pure active pharmaceutical ingredient in crystalline powder form, sometimes with excipients in final dosage products
Inhalation: Move person to fresh air; seek medical attention for ongoing symptoms like shortness of breath or cough
Skin Contact: Remove contaminated clothing; rinse skin under running water for at least 15 minutes; seek medical care for rash or allergic reaction
Eye Contact: Hold eyelids apart and flush eyes gently with water for 15 minutes; see a doctor if irritation persists
Ingestion: Rinse mouth with water; consult a healthcare provider if significant amounts swallowed or if allergic reaction develops
Special Guidelines: If person collapses or stops breathing, call emergency services and give CPR if trained; inform responders that antibiotics are involved
Suitable Extinguishing Media: Use water spray, dry chemical, CO₂, or foam
Unsuitable Extinguishing Media: Direct water jet may disperse powder
Special Hazards: May emit carbon monoxide, carbon dioxide, nitrogen oxides, and sulfur oxides if involved in fire
Protective Equipment: Firefighters should wear self-contained breathing apparatus and protective gear
Firefighting Procedures: Contain run-off to prevent contamination of sewers or waterways; cool exposed containers with water spray
Personal Protection: Put on appropriate gloves, goggles, and dust mask; avoid generating dust
Environmental Protection: Keep out of drains and open water
Cleanup Methods: Sweep up carefully, avoiding dust; transfer to suitable closed container for disposal; wash spill site with water after material pickup
Containment: Use inert material (sand, vermiculite) to absorb residue; ventilate area well
Handling: Minimize dust formation; don’t eat, drink, or smoke in work area; wear pharmaceutical lab attire and protective equipment
Storage: Store in tightly sealed containers in a cool, dry location away from incompatible materials (oxidizers); avoid excessive heat or moisture
Other Recommendations: Label storage area properly; limit access to trained staff; keep away from children and pets
Engineering Controls: Handle in a well-ventilated area or under fume hood; local exhaust preferred
Eye Protection: Wear chemical safety goggles
Skin Protection: Use non-porous gloves and long-sleeved lab coats
Respiratory Protection: Use NIOSH-approved particulate mask if dust becomes airborne
Occupational Exposure Limits: No OSHA or ACGIH limit established; follow standard laboratory good practice guidelines
Appearance: White to off-white crystalline powder
Odor: Odorless
pH: Neutral, aqueous solution pH about 4.5-6.0
Solubility: Sparingly soluble in water, slightly soluble in ethanol
Melting Point: 325°C (decomposes)
Molecular Weight: 365.41 g/mol
Boiling Point: Not applicable (decomposes before boiling)
Vapor Pressure: Negligible
Density: Not determined
Partition Coefficient: Not determined
Chemical Stability: Stable under normal conditions of storage and handling
Reactivity: Not expected to react violently in standard use
Incompatible Materials: Strong oxidizers, strong acids, strong bases
Hazardous Decomposition Products: May produce toxic vapors including carbon monoxide, CO₂, NOₓ, and SOₓ in fire
Conditions to Avoid: Moisture, elevated temperature, sunlight
Acute Toxicity: Oral LD50 in rodents >5000 mg/kg (low acute toxicity)
Skin & Eye Contact: Rabbit tests show mild irritation possible
Inhalation Effects: Dust may irritate respiratory tract
Sensitization: Known risk for skin and respiratory allergic reactions in exposed people
Chronic Effects: Prolonged exposure increases risk of allergic reactions or possibly hepatic effects; high doses may affect red blood cells
Mutagenicity/Carcinogenicity: Animal studies do not show significant mutagenic or carcinogenic potential
Reproductive Toxicity: Animal studies do not indicate risk, but medical advice should be sought before exposure during pregnancy
Ecotoxicity: Antibiotics can disrupt aquatic microbial activity; harmful to some aquatic species at high concentrations
Persistence and Degradability: Cephalexin shows moderate persistence; slow natural breakdown in the environment
Bioaccumulation: No significant potential for buildup in organisms
Mobility in Soil: Moderately mobile; can leach through soil, so avoid release to natural waters
Other Notes: Dispose of waste responsibly; do not flush into drains or surface water
Waste Handling: Gather contaminated material in sealable containers; label for pharmaceutical waste
Treatment Methods: Incinerate under controlled conditions in licensed facilities; follow local guidelines for hazardous waste disposal
Special Precautions: Do not dispose with regular garbage; avoid contaminating environment
Contaminated Packaging: Dispose as hazardous waste; follow regulations for disposal of medical/pharmaceutical packaging
UN Classification: Not regulated as dangerous under transport rules for air, road, or sea
Proper Shipping Name: Cephalexin Monohydrate
Hazard Label: None required
Packing Group: Not assigned
Special Transport Notes: Keep container closed, upright, and protected from moisture during transit; secure to avoid breakage
GHS Classification: Not classified as hazardous
OSHA Status: Not regulated
TSCA: Not listed
REACH Status: Exempt as medicinal product
California Proposition 65: Not listed
Other Regulatory Info: Monitor compliance with workplace safety and environmental protection laws in your area; pharmaceutical use requires prescription and pharmacist oversight
