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Product Name: Cefdinir
SYNONYMS: Omnicef, Cefdinir for Oral Suspension, Cefdinir Capsules
CAS Number: 91832-40-5
Manufacturer: Various pharmaceutical manufacturers
Recommended Use: Antibiotic – cephalosporin class
Contact Details: Refer to product package for manufacturer contact information
Emergency Contact: Local poison control center or medical professional
Hazard Classification: Not classified as hazardous according to GHS for finished pharmaceutical products; bulk powder may cause respiratory and skin sensitization
Label Elements: Signal word: Warning
Hazard Pictogram: Exclamation mark
Hazard Statements: May cause allergy or asthma symptoms or breathing difficulties if inhaled. May cause skin and eye irritation.
Precautionary Statements: Avoid breathing dust. Use in a well-ventilated area. Wear gloves/protective clothing/eye protection.
Cefdinir: ≥95% pure active ingredient (CAS 91832-40-5)
Inert ingredients: Excipients in formulated products such as fillers, binders, flavorings (vary by brand)
Impurities: Fewer than 2% total impurities; information available from Certificate of Analysis
Molecular Formula: C14H13N5O5S2
Molecular Weight: 395.41 g/mol
Inhalation: Move person to fresh air. Provide oxygen if breathing is difficult. Seek medical attention for persistent irritation or allergic response.
Skin Contact: Remove contaminated clothing. Wash skin with plenty of water and soap. If rash or irritation develops, consult a physician.
Eye Contact: Rinse cautiously with water for 15 minutes, lifting eyelids. Remove contact lenses if present. Obtain medical advice if irritation persists.
Ingestion: Rinse mouth. Do not induce vomiting unless directed by medical personnel. Seek medical help, especially for large exposures.
Symptoms and Effects: May include allergies, respiratory distress, nausea, vomiting, diarrhea, skin rashes.
Advice for First Responders: Use appropriate PPE. Avoid dust generation.
Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical powder, foam
Hazardous Combustion Products: Fumes of nitrogen oxides, sulfur oxides, carbon oxides
Specific Fire Hazards: Emits toxic fumes when burned
Protective Equipment for Firefighters: Self-contained breathing apparatus and full protective clothing
Special Procedures: Avoid inhalation of combustion products. Contain and collect water used for firefighting for proper disposal.
Personal Precautions: Use personal protective equipment. Avoid breathing dust. Evacuate area if necessary.
Environmental Precautions: Prevent entry into waterways, sewers, basements.
Spill Cleanup Methods: Sweep or mop up without generating dust. Use approved vacuum or wet cleaning methods. Place residue in closed container for waste disposal.
Decontamination: Wash spill area thoroughly.
Disposal: Follow applicable regulations for hazardous pharmaceutical waste.
Handling Precautions: Avoid contact with eyes, skin, and clothing. Use adequate ventilation. Minimize dust generation.
Storage Conditions: Store in tightly closed, labeled containers. Keep in a cool, dry, well-ventilated place, away from incompatible substances (e.g., strong oxidizers).
Incompatibility: Strong acids, bases, oxidizing agents.
Specific Uses: As prescribed by a healthcare professional, in formulation and production environments.
Exposure Limits: No occupational exposure limit established specifically for cefdinir. Use pharmaceutical industry guideline values if available.
Engineering Controls: Local exhaust ventilation, process enclosure, or other engineering controls to keep airborne levels below recommended exposure limits.
Personal Protective Equipment: Gloves (nitrile or latex), disposable gown/lab coat, safety glasses or goggles, NIOSH-certified respirators in case of dust generation.
Hygiene Measures: Wash thoroughly after handling. Do not eat, drink, or smoke while handling.
Environmental Exposure Controls: Avoid release to environment. Use containment during handling and processing.
Appearance: White to off-white crystalline powder
Odor: Odorless or faint odor
Odor Threshold: Not applicable
pH: 2.3 – 2.7 (in suspension)
Melting Point: Decomposes above 207°C
Boiling Point: Not applicable (decomposes upon heating)
Flash Point: Not flammable in finished form
Evaporation Rate: Not applicable
Flammability: Not flammable
Solubility in Water: Slightly soluble
Vapor Pressure: Not applicable
Density: ~1.6 g/cm³
Partition Coefficient (logP): -0.7
Viscosity: Not applicable
Chemical Stability: Stable under normal handling and storage conditions
Reactivity: Non-reactive under recommended conditions
Decomposition Products: Releases toxic gases such as nitrogen and sulfur oxides upon thermal decomposition
Conditions to Avoid: Heat, moisture, direct sunlight, strong acids or oxidizers
Polymerization: Will not occur
Incompatibles: Oxidizing agents, strong acids, strong bases
Routes of Entry: Inhalation, ingestion, skin and eye contact
Acute Toxicity: LD50 (oral, rat): >5,000 mg/kg
Potential Health Effects: Skin and respiratory sensitization, allergic reactions, gastrointestinal symptoms (nausea, diarrhea, abdominal pain), headache, rash
Chronic Effects: Prolonged or repeated exposure can cause hypersensitivity, antibiotic-associated colitis, alterations in gut flora
Carcinogenicity: Not listed as carcinogen by NTP, IARC, OSHA
Mutagenicity: Negative in standard tests
Reproductive Toxicity: No significant risk identified in animal studies
Target Organs: Gastrointestinal tract, skin, respiratory system
Ecotoxicity: Pharmaceuticals can impact aquatic organisms at low concentrations, though cefdinir shows low acute toxicity to fish and daphnia
Persistence/Degradability: Biodegradation data limited; likely persistent in water and soil
Bioaccumulation: Low potential for bioaccumulation (logP below zero)
Mobility in Soil: Likely moderate mobility based on solubility
Other Information: Avoid improper disposal as persistence in environment could affect microorganisms
Waste Treatment Methods: Do not dispose of via household waste or wastewater. Use approved hazardous pharmaceutical waste contractors.
Contaminated Packaging: Dispose of in accordance with local, national, and international regulations. Containers should be triple-rinsed and rendered unusable.
Special Precautions: Avoid release to the environment. Incinerate in a licensed facility if possible.
UN Number: Not regulated as hazardous waste under US RCRA, EU directives for finished dosage forms
UN Number: Not classified as dangerous for transport
Proper Shipping Name: Not regulated for air, sea, or ground freight as bulk pharmaceutical product
Transport Hazard Class: Not regulated
Packing Group: Not assigned
Special Precautions: Avoid generating dust during transport. Keep in original packaging.
Environmental Hazards: Not considered a marine pollutant.
Transport Label: No special labeling required for finished products.
US Regulations: FDA approved for prescription use. Not subject to TSCA reporting.
EU Regulations: Subject to EMA and REACH regulations for pharmaceutical substances
Workplace Exposure: No specific OSHA PEL or ACGIH TLV established.
Other Regulations: Listed on Japan ENCS, Canada DSL/NDSL, Australia AICS
Labeling: Prescription drug labeling governs usage and handling.
Special Restrictions: Observe all relevant regulations for antibiotics. Antimicrobial resistance addressed in pharmacovigilance policies.
