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Material Safety Data Sheet: Cephapirin Benzathine

Identification

Product Name: Cephapirin Benzathine
Chemical Formula: C34H36N8O8S2·C16H20N2O2
CAS Number: 97468-37-6
Common Use: Veterinary antibiotic administered by intramammary infusion
Synonyms: Benzathine cephapirin, 7-[D-2-amino-2-phenylacetamido]-3-(2-thienylacetamido)-3-cephem-4-carboxylic acid, Benzathine salt
Manufacturer: Refer to individual supplier’s contact information on package insert
Recommended Use: Treatment of bovine mastitis
Emergency Contact: According to local, national, or supplier-specific regulations

Hazard Identification

GHS Classification: Not classified as hazardous according to current GHS criteria for pharmaceuticals
Health Hazards: May cause allergic reactions in individuals sensitive to beta-lactam antibiotics. Can provoke skin, eye, or respiratory irritation with exposure. Accidental ingestion, inhalation, or direct injection may result in systemic toxicity, such as gastrointestinal discomfort and hypersensitivity.
Environmental Hazards: Spills entering waterways may harm aquatic life.
Pictogram: None mandated
Signal Word: Warning
Precautionary Statements: Avoid contact with eyes, skin, and clothing. Prevent release to environment. Seek medical attention if symptoms develop.

Composition / Information on Ingredients

Cephapirin Benzathine: 95-100% (active pharmaceutical ingredient)
Excipients: Formulation may include inert diluents, stabilizers, or buffering agents in trace concentrations.
Impurities: Related compounds below regulatory disclosure limits

First Aid Measures

Inhalation: Move person to fresh air. Provide ventilatory support if breathing becomes difficult. Seek immediate medical attention for persistent symptoms.
Skin Contact: Remove contaminated clothing. Wash exposed area thoroughly with soap and water. Seek treatment for rashes or allergic responses.
Eye Contact: Rinse eyes gently yet thoroughly for at least 15 minutes. Lift eyelids repeatedly. Contact healthcare professional for sustained irritation.
Ingestion: Rinse mouth with water. Do not induce vomiting unless directed by medical staff. Give water to drink only if person is conscious. Monitor for allergic reactions; seek prompt medical assistance.

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, dry chemical, foam, or carbon dioxide.
Specific Hazards: Combustion releases hazardous fumes such as carbon monoxide, carbon dioxide, and nitrogen/sulfur oxides.
Protective Equipment: Firefighters should wear full protective gear including self-contained breathing apparatus.
Special Procedures: Move containers from hazard area if safe. Prevent fire-fighting runoff from entering waterways or drains.

Accidental Release Measures

Personal Protection: Wear suitable gloves, chemical-resistant body covering, and eye protection. Consider respiratory protection for dusts.
Spill Response: Ventilate contaminated area. Collect spilled material with inert absorbent. Avoid dispersing dust.
Disposal: Place collected waste in labeled containers for disposal in accordance with regional and national guidelines.
Environmental Precaution: Prevent entry into drains, waterways, and soil to reduce environmental contamination.

Handling and Storage

Handling: Minimize contact with skin, eyes, and clothing. Do not eat, drink, or smoke during use. Practice good industrial hygiene.
Storage Conditions: Store tightly closed in original container, in a cool, dry, well-ventilated place. Protect from light and moisture. Keep separate from oxidizing agents and incompatible chemicals.
Special Sensitivities: Individuals known to have allergic reactions to cephalosporins or penicillins should avoid exposure.
Containers: Only use materials compatible with pharmaceutical standards.

Exposure Controls and Personal Protection

Engineering Measures: Use local exhaust ventilation. Employ closed systems where feasible.
Occupational Exposure Limits: Not established for cephapirin benzathine. In the absence of data, minimize dust/gas exposure to lowest practicable level.
Personal Protective Equipment (PPE): Laboratory coats, chemical- and puncture-resistant gloves, safety goggles. Use NIOSH-approved respirators if airborne dust or mist expected.
Workplace Hygiene: Wash hands after handling and before breaks. Remove contaminated clothing.

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless or faint medicinal smell
pH (in aqueous solution): 3.5–5.5
Melting Point/Range: Data not available
Solubility: Practically insoluble in water; slightly soluble in organic solvents
Partition Coefficient (log Pow): Not determined
Boiling Point: Not relevant (decomposes before boiling)
Vapor Pressure: Negligible
Density: Not reported
Flammability: Not highly flammable under normal conditions

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions.
Reactivity: Incompatible with strong acids, strong bases, and oxidizing agents.
Hazardous Reactions: No dangerous reactions anticipated with proper use and storage.
Hazardous Decomposition: Burning may produce carbon monoxide, carbon dioxide, sulfur oxides, nitrogen oxides.

Toxicological Information

Acute Toxicity: Data in animals limited; oral LD50 in rodents estimated above 2,000 mg/kg.
Chronic Exposure: Repeated contact can result in dermatitis or sensitization. Prolonged exposure might affect blood and kidney functions.
Allergic Response: Individuals previously sensitized to beta-lactam antibiotics have increased risk for anaphylaxis or skin eruptions.
Symptoms of Exposure: Rash, urticaria, breathing difficulty, fever, gastrointestinal upset.
Carcinogenicity: No evidence from animal studies. Not listed by IARC, NTP, or OSHA as carcinogen.
Mutagenicity/Teratogenicity: No proven risk indicated in study summaries. Consult full toxicology report or literature.

Ecological Information

Ecotoxicity: Harmful to aquatic organisms at low concentrations. Discharge to waterways may disturb microbial communities.
Persistence and Degradability: Moderately persistent; slow biodegradation under typical environmental conditions.
Bioaccumulation: Potential low due to ionic nature of molecule.
Mobility: Weak adsorptive character in soils; potential mobility into groundwater if released.
Other Effects: Veterinary residues may contribute to antimicrobial resistance in the environment.

Disposal Considerations

Waste Disposal Method: Collect unused or waste product and dispose of via incineration in an approved facility. Avoid direct landfill. Dilute solutions or contaminated packaging treated as hazardous waste.
Contaminated Containers: Rinse thoroughly before recycling or landfilling in accordance with local, national, and international regulations.
Regulatory Reference: Follow regional pharmaceutical waste directives and consult product label for disposal codes.

Transport Information

UN Number: Not assigned for standard pharmaceutical preparations
Transport Hazard Class: Not regulated as dangerous goods by road (ADR), air (IATA), or sea (IMDG).
Packing Group: Not applicable
Special Precautions: Avoid physical damage to containers. Secure against spillage and moisture.

Regulatory Information

Inventory Status: Listed or exempted under major global chemical inventories for pharmaceutical active substances.
Labeling Requirements: Comply with applicable standards for veterinary pharmaceuticals. Product label must outline hazards and safety instructions.
OSHA Hazard Communication: Pharmaceutical preparations for therapeutic use generally exempt.
National/International Regulations: Subject to prescription veterinary drug controls; not to be administered to animals for human consumption without observing country-specific withdrawal periods.
Restrictions/Prohibitions: Regulated under environmental, health, and safety standards by local authorities.