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Product Name: Cefprozil Monohydrate
Chemical Name: (6R,7R)-7-[(R)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3-propen-1-yl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate
CAS Number: 98169-33-8
Recommended Use: Pharmaceutical intermediate / Active pharmaceutical ingredient
Manufacturer: Refer to local supplier or licensed pharmaceutical manufacturer
Emergency Contact: Consult local poison control center or chemical emergency hotline for immediate action
GHS Classification: Not classified as hazardous according to current regulations; handle with care since pharmaceutical agents can sensitise or irritate
Signal Word: Warning
Hazard Statements: May cause skin and eye irritation, respiratory symptoms, possible allergic reactions in sensitive individuals
Precautionary Statements: Avoid breathing dust or aerosol. Wash hands thoroughly after handling. Wear suitable gloves and eye protection. Seek medical advice in case of exposure.
Routes of Exposure: Inhalation, ingestion, skin contact, eye contact
Potential Health Effects: Allergic reactions, such as rash or difficulty breathing, may develop. Those with penicillin or cephalosporin allergies may experience more severe effects.
Cefprozil Monohydrate: Typically >98% purity
Impurities: Possibly trace solvents, related cephalosporin by-products
Excipient Materials: None in API; finished dosage forms contain lactose, microcrystalline cellulose, and coloring agents as per formulation
Inhalation: Remove individual to fresh air. Get medical advice if respiratory symptoms develop. Oxygen or respiratory support as directed by physician.
Skin Contact: Wash thoroughly with soap and water. Remove contaminated clothing. Watch for rash or allergic response. Seek medical care if irritation or symptoms persist.
Eye Contact: Rinse cautiously with water for 15 minutes. Remove contact lenses if present. Get medical attention for persistent discomfort.
Ingestion: Rinse mouth. Do not induce vomiting unless instructed by medical personnel. Get medical attention immediately. Monitor allergic response and provide emergency treatment if necessary.
Notes for Physician: Symptomatic treatment as required. Allergic individuals may need corticosteroids, antihistamines, or epinephrine for severe reaction.
Suitable Extinguishing Media: Dry chemical, carbon dioxide, water spray, or foam
Specific Hazards: During fire, toxic or irritating gases such as oxides of nitrogen, sulfur, and carbon can form.
Protective Equipment: Wear self-contained breathing apparatus and full protective clothing during fire events.
Firefighting Procedures: Move containers away from fire area if safe. Prevent runoff from entering drains or water bodies.
Personal Precautions: Use personal protective equipment, including gloves, goggles, and dust respirator. Wash hands after clean-up.
Environmental Precautions: Avoid release into drains, watercourses, or soil.
Spill Cleanup Methods: Collect spilled material with inert absorbent (e.g., sand, diatomaceous earth). Dispose in tightly closed container. Ventilate area after clean-up, and wash down surfaces.
Handling Practices: Minimise dust generation and accumulation. Wear suitable protective equipment. Provide adequate ventilation.
Storage Conditions: Store in tightly closed original container in cool, dry, well-ventilated place away from incompatible substances (strong acids, oxidizers). Protect from light and moisture.
Incompatibilities: Strong oxidising agents, acids, alkaline substances
Specific Workplace Controls: Implement standard operating procedures for avoiding cross-contamination and maintaining cleanliness
Exposure Limits: No official occupational exposure limits established; avoid unnecessary exposure
Engineering Controls: Local exhaust ventilation or containment to manage dust and aerosol formation
Personal Protective Equipment: Chemical-resistant gloves, lab coats, splash goggles or face shield, dust or particulate respirator if airborne exposure risk exists
Hygiene Measures: Wash hands and exposed areas thoroughly before eating, drinking, or smoking. Remove contaminated clothing and clean before reuse
Appearance: White to off-white powder
Odor: Odorless or slight chemical odor
pH (1% solution): 4.0–6.0
Melting Point: Around 120–130°C (decomposes)
Solubility: Slightly soluble in water, very slightly in methanol, insoluble in most organic solvents
Partition Coefficient: Not readily available; low
Vapor Pressure: Negligible
Density: Approximately 1.7 g/cm³
Other Data: Stable under stated storage conditions
Chemical Stability: Stable under recommended conditions. Decomposes by strong acids/bases or oxidation.
Conditions to Avoid: Exposure to light, heat, and moisture
Materials to Avoid: Strong oxidizing agents, acids, bases
Hazardous Decomposition Products: Nitrogen oxides, sulfur oxides, carbon oxides. Degradants may be sensitizing or irritating.
Reactivity Details: Reacts slowly in aqueous acidic or alkaline solutions.
Acute Toxicity: Oral median lethal dose (LD50) in animals >5,000 mg/kg; low acute toxicity by oral, dermal, or inhalational routes
Possible Effects: Allergic reactions including skin erythema, urticaria, or respiratory symptoms. May cause gastrointestinal disturbances such as nausea or diarrhea.
Sensitisation: Skin and respiratory sensitizer in individuals allergic to cephalosporins or penicillins
Chronic Exposure: Prolonged occupational exposure may increase risk of developing sensitivity
Carcinogenicity/Mutagenicity: No evidence found from available studies
Reproductive Toxicity: Animal studies do not show significant risks; handle with care especially in pharmaceutical manufacturing
Ecotoxicity: Limited data indicates moderate risk to aquatic organisms; antibiotics can disrupt microbial ecology
Persistence and Degradability: Partially biodegradable; some cephalosporins may persist in soil or sediment
Bioaccumulative Potential: Not expected to bioaccumulate
Mobility in Soil: High mobility due to water solubility; possible contamination of aquatic habitats
Other Considerations: Avoid uncontrolled disposal; trace environmental residues can promote antimicrobial resistance
Unused Product Disposal: Incinerate in approved facility or dispose of as pharmaceutical waste under regulatory requirements
Contaminated Packaging: Rinse containers before disposal; follow local hazardous waste protocols
Do Not Discharge: Avoid releasing into drains, surface water, or soil; report large spills to environmental authorities
UN Number: Not classified as hazardous for transport under ADR, RID, IATA, IMDG
Proper Shipping Name: Not regulated for air, sea, or road shipping
Packing Group: Not required; package securely to avoid breakage and exposure
Special Precautions: Protect from moisture and physical damage; keep away from incompatible substances during transit
International Regulations: Not subject to international chemical control lists (such as REACH, TSCA) as an active pharmaceutical ingredient
Labeling Requirements: Pharmaceutical labeling applies; safety labeling recommended for workplace handling
Worker Protection: OSHA, EU Directives, and country-specific worker health and safety laws apply; observe occupational exposure risk statements
Additional Information: Handle in line with good laboratory and manufacturing practice guidelines; keep safety data updated and readily accessible for all personnel.
