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Product Name: Ceftriaxone Sodium
Chemical Family: Cephalosporin antibiotic
SYNONYMS: Rocephin, Ceftriaxone Disodium Hemipentahydrate
CAS Number: 104376-79-6
Intended Use: Pharmaceutical raw material, clinical antimicrobial treatment
Supplier: Pharmaceutical manufacturer or authorized distributor contact info
Emergency Contact Number: National Poison Control Hotline or emergency medical provider
Molecular Formula: C18H16N8Na2O7S3·3.5H2O
Molecular Weight: 661.60 g/mol (anhydrous basis)
GHS Classification: Not classified as hazardous under GHS regulations for most industrial uses
Hazard Statements: May cause allergic reactions, possible respiratory tract irritation, possible eye and skin irritation
Signal Word: Warning
Pictograms: Exclamation mark for potential irritant
Primary Risks: Allergic responses, mild to moderate irritation of exposed tissues, impacts for individuals with known penicillin or cephalosporin allergy
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Medical Conditions Aggravated: Beta-lactam hypersensitivity, renal impairment
Ceftriaxone Sodium: 95-100%
Other Ingredients: Trace water as crystallization hydrate; no other excipients in pure raw API
Impurities: Less than 2%, in accord with pharmacopeial specifications
Inhalation: Move to fresh air, seek medical attention if symptoms like shortness of breath, coughing, or swelling occur
Skin Contact: Wash with plenty of soap and water for at least 15 minutes, remove contaminated clothing, seek advice if irritation develops
Eye Contact: Rinse immediately with lots of clean running water for at least 15 minutes, hold eyelids apart, get medical aid for persistent effects
Ingestion: Rinse mouth with water, never give anything by mouth to an unconscious person, call a medical professional
Most Important Symptoms: Allergic reaction signs include rash, swelling, redness, difficulty breathing
Recommendations for Immediate Medical Care: Observation for allergic anaphylaxis, supportive therapy as indicated
Suitable Extinguishing Media: Dry chemical, carbon dioxide, water spray, or foam
Specific Hazards from Combustion: May produce hazardous and irritating fumes like carbon oxides, nitrogen oxides, sulfur oxides upon thermal decomposition
Protective Equipment for Firefighters: Full protective suit, self-contained breathing apparatus
Instructions: Stay upwind, avoid inhalation of combustion by-products, contain run-off to prevent entry into water systems
Personal Precautions: Wear protective gloves, safety goggles, protective lab coat or gown
Environmental Precautions: Prevent large quantities from entering drains, sewers, or surface water
Spill Response: Collect spilled powder with shovel or vacuum with HEPA filtration, place in suitable container for waste, wash area with water, ventilate the location
Disposal of Clean-up Materials: Double-bag contaminated items, handle as pharmaceutical waste
Handling: Use only in designated, well-ventilated work areas, avoid breathing dust, use proper engineering controls and avoid skin or eye contact
Storage Conditions: Store at controlled room temperature, ideally below 25°C, away from light, heat, and moisture, in a tightly closed, clearly labeled container
Incompatibilities: Avoid strong oxidizers and acids
Special Precautions: Access for authorized personnel only, maintain good housekeeping practices to avoid contamination
Exposure Limits: No established OSHA or ACGIH exposure limits for ceftriaxone
Engineering Controls: Local exhaust ventilation, biological safety cabinet for open handling of powder
Personal Protective Equipment: Nitrile or latex gloves, protective gown, chemical splash goggles, fitted mask or ventilator for fine powder
Hygiene Measures: Wash hands after manipulation, do not drink or eat in handling areas, remove contaminated clothing and equipment before entering public spaces
Appearance: White to yellowish crystalline powder
Odor: Odorless
pH in Solution: 6.0–8.0 for 1% solution
Melting Point: Decomposes before melting at high temperature
Solubility: Highly soluble in water, sparingly soluble in methanol, practically insoluble in acetone and chloroform
Partition Coefficient: Log P (octanol/water) estimated at less than 0, very hydrophilic
Other Data: Stable under recommended conditions, light sensitive
Chemical Stability: Stable under standard laboratory and storage conditions
Reactivity: Not reactive under normal use, sensitive to acid and alkaline pH extremes
Conditions to Avoid: Unshielded heat sources, sunlight, damp or humid conditions
Decomposition Products: Toxic fumes of carbon, nitrogen, and sulfur oxides
Hazardous Reactions: No dangerous polymerization reported
Acute Toxicity: Low acute toxicity in standard animal models, LD50 (oral, rats) >5000 mg/kg
Chronic/Long-term Effects: Allergic reaction possible at low exposure for sensitive individuals, rare blood and kidney effects at high or repeated medical dosages
Carcinogenicity: No known carcinogen classification by IARC, NTP, or OSHA
Mutagenicity & Teratogenicity: No mutagenic or teratogenic effects in standard tests
Human Effects: Most common adverse events are gastrointestinal upset, injection site pain, allergy in predisposed persons
Other Effects: May disturb normal gut or renal flora in excessive workplace exposure
Ecotoxicology: Data on direct aquatic toxicity is limited for ceftriaxone, but antibiotics in water may promote resistance in microorganisms, harm beneficial bacteria, disrupt aquatic life at high levels
Mobility in Soil: High water solubility suggests potential mobility through soil and water
Persistence and Degradability: Generally biodegradable but may persist for weeks under anaerobic conditions
Bioaccumulation: Not likely due to hydrophilicity
Other Risks: Continuous release to environment should be minimized, all antibiotic wastes need careful management
Waste from Residues: Treat as pharmaceutical or chemical waste, do not dispose through regular trash or drainage
Container Disposal: Triple rinse, render non-reusable, dispose via licensed pharmaceutical waste contractor
Recommended Disposal Methods: Incineration or chemical treatment in compliance with local, state, and national environmental control regulations
Precautions: Do not incinerate closed containers, avoid environmental contamination during handling and transport
UN Number: Not assigned as dangerous for transport
Proper Shipping Name: Ceftriaxone Sodium, not regulated
Transport Hazard Class: Not classified
Packing Group: Not required
Environmental Hazards: Not designated as marine pollutant
Special Precautions: Standard safety packaging, secure containers to prevent breakage, documentation for prescription drug substances
OSHA Status: Not recognized as hazardous chemical under US OSHA Hazard Communication Standard
TSCA Status: Not regulated under TSCA due to pharmaceutical application
SARA Title III: Not listed as an extremely hazardous substance
FDA: Prescription medication, subject to federal and state regulations for therapeutic drugs
EU Regulations: Not classified as hazardous, but subject to pharma registration and drug safety directives
Other Regulatory Requirements: Observe all local, national, and international regulations for handling antibiotics and prescription pharmaceuticals, with consideration of worker protection laws and environmental regulations
