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Product Name: Cefadroxil Monohydrate
Synonyms: Cefadroxil, 7-(2-amino-2-phenylacetamido)-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate
CAS Number: 68167-08-0
Intended Use: Active pharmaceutical ingredient, antibiotic
Manufacturer Details: Provided by supplier, with address, emergency phone, and contact for technical information included in documentation.
Classification: May cause allergic reactions in sensitive individuals. Not classified as hazardous for supply according to GHS criteria. Dust may cause respiratory tract irritation with excessive exposure.
Label Elements: No standardized hazard pictogram under GHS.
Health Hazards: Allergic skin or respiratory reactions, eye irritation, gastrointestinal discomfort upon ingestion.
Environment Hazards: Harmful to aquatic life in larger spills.
Precautionary Statements: Avoid breathing dust. Wash hands thoroughly. Use personal protection following local guidance.
Chemical Name: Cefadroxil Monohydrate
Common Name: Cefadroxil
Concentration: >98% by weight
Impurities: Trace solvents or process impurities below safety thresholds
Molecular Formula: C16H17N3O5S•H2O
Molecular Weight: Approx. 381.4 g/mol
Inhalation: Move exposed person to fresh air. Seek medical attention if symptoms occur.
Skin Contact: Remove contaminated clothing. Wash skin with soap and plenty of water. Seek help for rash, irritation, or ongoing pain.
Eye Contact: Rinse open eyes with water for several minutes. Remove contacts if possible and continue rinsing. Get medical help for persistent irritation.
Ingestion: Rinse mouth. Do not induce vomiting. Call poison center or healthcare provider if feeling unwell or sensitive to beta-lactam antibiotics.
Signs and Symptoms: Rash, redness, hives, shortness of breath, gastrointestinal upset, allergic reaction in previously sensitized individuals.
Suitable Extinguishing Media: Use water fog, dry chemical, foam, or carbon dioxide as required by surrounding fire.
Special Hazards: Thermal decomposition can produce oxides of carbon, nitrogen, and sulfur.
Protective Equipment: Firefighters should use self-contained breathing apparatus and protective clothing to avoid exposure to fumes.
Other Information: Avoid inhalation of combustion products. Contain runoff using procedures for pharmaceutical chemicals.
Personal Precautions: Keep unnecessary personnel away. Deploy personal protective equipment including respirator, gloves, and goggles.
Spill Response: Sweep up material with minimum dust production. Place in a closed container for proper disposal.
Environmental Precautions: Prevent release into drains, soil, or waterways.
Cleaning Method: Use HEPA-filtered vacuum or damp methods to minimize airborne particles. Do not dry sweep.
Handling: Use with adequate ventilation or local exhaust. Handle powder in closed processes. Avoid inhaling dust or ingesting product. Wear lab coat, eye protection, and gloves.
Storage: Store closed in a cool, dry location away from strong acids, bases, and oxidizers. Protect from light and moisture. Segregate from incompatible materials.
Other Recommendations: Avoid contact with skin, eyes, or clothing. Follow hygiene measures—wash hands after handling and before eating or drinking.
Exposure Limits: No occupational exposure limits established for cefadroxil; minimize exposure by good laboratory practices.
Engineering Controls: Use chemical fume hood, ventilated enclosure, or local exhaust for bulk handling.
Respiratory Protection: Use NIOSH-approved dust respirator if airborne dust risk cannot be eliminated.
Eye Protection: Wear safety glasses with side shields or chemical goggles.
Hand Protection: Chemical-resistant gloves recommended.
Other Protection: Use lab coat or disposable coveralls to prevent skin exposure. Remove contaminated clothing immediately.
Appearance: White to off-white crystalline powder
Odor: Characteristic, faint
Odor Threshold: Not established
pH: 4.0–6.0 (1% solution)
Melting Point: Decomposes before melting
Boiling Point: Not applicable
Flash Point: Not applicable
Vapor Pressure: Negligible
Solubility: Slightly soluble in water, more soluble in dilute acids and alkalis
Partition Coefficient: Not available
Decomposition Temperature: Above 200°C releases toxic fumes
Density: Approx. 1.5 g/cm³
Other Properties: Stable under recommended storage, hygroscopic
Chemical Stability: Stable under recommended storage and handling conditions
Reactivity: No known hazardous reactions under normal use
Incompatible Materials: Strong acids, strong bases, oxidizing agents
Hazardous Decomposition: Produces toxic fumes of nitrogen oxides, sulfur oxides, and carbon oxides during decomposition
Polymerization: Not likely to occur
Acute Toxicity: Data for cefadroxil show low acute oral toxicity in animals (LD50 rat: >5,000 mg/kg)
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Symptoms: Allergic reactions in susceptible individuals, nausea, vomiting, diarrhea, rare risk of anaphylaxis
Chronic Effects: Repeated or prolonged exposure can sensitize skin or respiratory tract
Carcinogenicity: Not listed by IARC, NTP, or OSHA
Mutagenicity and Reproductive Toxicity: No mutagenic or reproductive effects reported in available studies
Aquatic Toxicity: May be harmful to aquatic life at high concentrations, long-term data limited
Persistence and Degradability: Not readily biodegradable, expected to degrade slowly in environment
Bioaccumulation: Not expected to bioaccumulate
Mobility: Highly mobile in water due to solubility, may leach to groundwater
Other Adverse Effects: Antibiotics may disturb aquatic microbial ecology with prolonged discharge
Waste Disposal: Dispose of as pharmaceutical waste in accordance with local, regional, and national regulations
Incineration: Preferred method for bulk waste under controlled conditions
Packaging Disposal: Decontaminate and dispose of empty containers as chemical waste
Prevent Release: Spilled materials must not enter drains or watercourses
UN Number: Not assigned
Transport Hazard Class: Not regulated for transport by ADR, IMDG, IATA
Packing Group: Not applicable
Environmental Hazards: No significant hazard under normal transport conditions
Special Precautions: Protect from moisture, avoid rough handling to minimize container breakage
Labeling: No mandatory hazard label for supply required
Safety Assessments: Covered by pharmaceutical ingredient regulations in many countries, subject to prescription-use laws
Other Regulations: Subject to workplace control measures and occupational health and safety rules in handling, storage, disposal
Inventory Status: Listed on chemical inventories such as TSCA (USA) if relevant, controlled under national drug regulations for production and use
