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Product Name: Cefotiam Hydrochloride
Synonyms: Cefotiam dihydrochloride, Cefotiam HCl
Chemical Formula: C18H18N8O5S3·2HCl
Molecular Weight: 601.45 g/mol
Manufacturer: Pharmaceutical suppliers, bulk chemical manufacturers
CAS Number: 5575-21-3
Intended Use: Active pharmaceutical ingredient for injectable antibiotic drugs targeting Gram-positive and Gram-negative bacteria
Contact Information: Emergency and non-emergency contacts found on packaging labels per local regulations
GHS Classification: Not classified as hazardous under GHS but pharmaceutical workers need to avoid exposure
Main Hazards: May cause allergies, respiratory irritation, and skin or eye irritation in sensitive individuals
Physical Hazards: Dust may form explosive mixtures with air in high concentrations, avoid sources of ignition
Health Hazards: Inhalation, skin absorption, ingestion may lead to allergic reactions such as rashes or respiratory symptoms; repeated contact could cause sensitization
Environment Hazards: Large quantities may negatively impact aquatic systems
Active Ingredient: Cefotiam Hydrochloride, ≥98% purity
Impurities: Trace organic or inorganic process impurities & solvent residues, usually below 2%
Inactive Ingredients: Pharmaceutical grade product; excipients present only in compounded preparations and not in raw powder
Chemical Character: Crystalline powder, white or light yellow
Inhalation: Move patient to fresh air, keep at rest, seek medical attention if symptoms develop such as coughing, wheezing, or breathlessness
Skin Contact: Immediately remove contaminated clothing, wash affected area with soap and water, seek medical help if irritation persists
Eye Contact: Rinse cautiously with water for at least 15 minutes, remove contact lenses if present, seek medical attention if irritation continues
Ingestion: Rinse mouth with water, do NOT induce vomiting, seek medical assistance at once
Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, or appropriate foam
Unsuitable Extinguishing Media: High volume water jet may spread powder and contamination
Special Hazards: Decomposition at high temperature releases CO, CO2, nitrogen oxides, sulfur oxides, hydrochloric acid fumes
Protective Equipment: Firefighters need full protective equipment and self-contained breathing apparatus
Precautions: Avoid inhaling combustion fumes and runoff water contamination of water bodies
Personal Precautions: Ensure adequate ventilation, avoid dust generation, wear personal protection: gloves, mask, goggles, lab coat
Emergency Procedures: Evacuate non-essential personnel from spill area
Spill Cleanup: Use disposable absorbent materials, scoop up and place in chemical waste container, clean surface with water and detergent, ventilate area
Environmental Precautions: Prevent large releases from entering drains, surface water or soil
Precautions for Safe Handling: Avoid breathing dust, do not get into eyes or on skin, practice good hygiene and wear proper PPE (personal protective equipment)
Technical Measures: Use only in well-ventilated areas or fume hood, minimize airborne dust, have spill control materials ready
Conditions for Safe Storage: Store in tightly closed containers, protected from light, at 2°C–8°C (refrigerator temperature)
Incompatible Materials: Strong oxidizers, acids, alkalis may degrade product
Storage Area Requirements: Pharmaceutical-grade storage, comply with cGMP if intended for clinical/industrial use
Exposure Limits: Occupational exposure limits not established; use pharmaceutical standards (<10 μg/m3 as a general precaution for cephalosporin antibiotics)
Engineering Controls: Local exhaust ventilation or containment enclosure recommended
Personal Protective Equipment: Gloves, laboratory coat, N95 or higher respiratory protection for dusty environments, safety goggles
Hygienic Practices: Wash hands after handling, avoid eating, drinking, or smoking in work area, change and wash contaminated clothing before reuse
Appearance: White to slightly yellowish crystalline powder
Odor: Odorless
pH (solution): 2.0 - 4.5 (5% aqueous solution)
Melting Point: Decomposes above 180°C
Boiling Point: Not applicable (decomposes)
Solubility: Freely soluble in water, practically insoluble in organic solvents such as ether & chloroform
Partition Coefficient (log P): <0
Vapor Pressure: Not volatile
Relative Density: Approximately 1.7 g/cm³
Flash Point: Not applicable (non-combustible solid)
Chemical Stability: Stable under recommended handling and storage conditions
Reactivity: No special reactivity hazards
Decomposition Products: CO, CO2, NOx, SOx, HCl under fire or high heat
Incompatible Materials: Strong oxidizing agents, strong acids, strong bases promote hydrolysis and degradation
Hazardous Reactions: None during normal processing and storage
Acute Toxicity: Oral LD50 (rat): >2000 mg/kg, low toxicity in single dose
Routes of Exposure: Inhalation, skin and eye contact, accidental ingestion
Symptoms: May cause allergic reactions: skin rash, hives, respiratory problems, rarely more severe cephalosporin hypersensitivity
Chronic Effects: Prolonged or repeated contact can lead to sensitization or asthmatic reactions in susceptible handlers
Carcinogenicity: Not listed as carcinogen by IARC, NTP, OSHA
Mutagenicity: No significant genotoxic effects reported in standard tests
Reproductive Toxicity: No strong evidence for adverse reproductive effects in animal studies, but use caution
Ecotoxicity: May be harmful to aquatic life at high concentrations, low environmental persistence in treated sewage
Persistence and Degradability: Decomposes under sunlight and via microbial activity
Bioaccumulation Potential: Low, does not significantly accumulate in organisms
Mobility in Soil: Highly soluble in water, may be mobile in aqueous environments before breakdown
Aquatic Toxicity: Specific data scarce but prudent to limit environmental release
Waste Disposal Methods: Dispose of in accordance with local, regional, and national waste regulations. Incineration recommended for quantities >1kg; diluted residue can be handled as pharmaceutical waste for smaller volumes
Contaminated Packaging: Triple rinse, then dispose as hazardous waste or by incineration
Environmental Precautions: Avoid release to soil, water, or municipal drains
UN Number: None assigned for Cefotiam Hydrochloride as a pharmaceutical ingredient
Proper Shipping Name: Non-hazardous for transport based on current regulations
Transport Hazard Class: Not regulated
Packing Group: Not applicable
Special Transport Precautions: Ship in sealed packaging, protect from moisture and extreme temperature; accompany with documentation for traceability
US FDA: Approved active pharmaceutical ingredient for prescription use
OSHA: Not specifically listed, general pharmaceutical control measures apply
REACH/CLP (EU): Not classified as hazardous, use in compliance with pharmaceutical substance regulations
IATA/ADR/RID: Not classified as dangerous goods
WHMIS (Canada): Not controlled when used as intended for manufacture or compounding; proper workplace labeling recommended
Other local/national regulations: Country-specific requirements for licensing, handling, and worker safety may apply. Regularly review updates to regulations and workplace safety protocols
