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Product Name: Azithromycin Dihydrate
Chemical Formula: C38H72N2O12·2H2O
Chemical Family: Macrolide antibacterial
Synonyms: Zithromax, Azithromycin hydrate
CAS Number: 117772-70-0
Intended Use: Pharmaceutical antibiotic agent
Manufacturer: Refer to supplier
Emergency Contact: Local poison control or emergency response agency
Hazard Classification: Not classified as hazardous according to GHS
Health Hazards: May cause irritation to eyes, skin and respiratory tract; some individuals can develop allergic reactions; ingestion of large amounts can lead to gastrointestinal symptoms such as nausea, vomiting, diarrhea
Label Elements: No pictogram required, but general lab hygiene should be maintained
Precautionary Statements: Avoid direct contact; wash hands thoroughly after handling; minimize dust generation and inhalation
Other Hazards: Not considered combustible, but excessive dust could present an inhalation hazard
Ingredient Name: Azithromycin Dihydrate
Concentration: >98% (pharmaceutical grade)
Impurities: Typical pharmaceutical trace impurities below regulatory thresholds
Inhalation: Immediately move person to fresh air; seek medical attention for any persistent irritation or symptoms
Skin Contact: Remove contaminated clothing; wash affected skin with plenty of soap and water; consult a physician if irritation or rash develops
Eye Contact: Flush eyes with plenty of water for at least 15 minutes; consult medical attention if irritation persists
Ingestion: Rinse mouth thoroughly, do not induce vomiting without medical advice; seek medical assistance for notable symptoms or ingestion of large quantity
Personal Protection for Rescuers: Wear gloves, mask, and waterproof clothing when assisting affected individuals
Suitable Extinguishing Media: Water spray, foam, dry chemical, carbon dioxide
Unsuitable Media: Avoid direct water jet to minimize dust spread
Fire Hazards: Product does not ignite easily, but packaging may; thermal decomposition may release nitrogen and carbon oxides
Protective Equipment for Firefighters: Use self-contained breathing apparatus and full protective clothing
Advice to Firefighters: Avoid inhalation of smoke, fumes; use water spray to cool containers exposed to fire
Personal Precautions: Restrict access to spill area; ensure adequate ventilation; wear gloves, eye protection, and dust mask
Environmental Precautions: Prevent entry into drains, surface water, and soil
Cleanup Methods: Pick up spills with a damp cloth or absorbent; collect in a sealable container for safe disposal; avoid dust formation during cleaning
Handling: Maintain good industrial hygiene; avoid contact with eyes, skin, and clothing; minimize dust creation; wash hands after use
Storage Conditions: Store in original container, tightly closed, in a cool, dry, well-ventilated space, away from incompatible reactants such as strong oxidizers
Special Requirements: Keep away from food, beverages, and animal feed; store out of reach of children; do not reuse empty containers
Exposure Limits: No established occupational exposure limit; minimize exposures as low as reasonably achievable
Engineering Controls: Use local exhaust or general ventilation to keep airborne concentrations low
Personal Protective Equipment: Gloves, safety goggles, lab coat; if dust risk is present, use a dust mask or approved respirator
Hygiene Measures: Change contaminated clothing; always wash hands and face after handling
Appearance: White to off-white crystalline powder
Odor: Faint, medicinal odor
Molecular Weight: 785.0 g/mol
Solubility: Slightly soluble in water; more soluble in methanol and ethanol
pH (solution): 6.0 – 9.0
Melting Point: Decomposes above 125°C
Boiling Point: Not applicable (decomposes prior to boiling)
Partition Coefficient (Log Kow): Approximately 2.4
Vapor Pressure: Negligible at room temperature
Chemical Stability: Stable under normal temperatures and storage conditions
Reactivity: Not reactive under regular handling or storage practices
Conditions to Avoid: Avoid extreme heat, light, and moisture
Incompatible Materials: Strong oxidizers, acids
Hazardous Decomposition Products: Nitrogen oxides, carbon monoxide, carbon dioxide
Polymerization: Not expected to occur
Acute Toxicity: Oral LD50 in rats exceeds 2000 mg/kg; considered low toxicity in small doses
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Symptoms: May cause irritation, allergic skin reactions, nausea, diarrhea
Chronic Effects: Data suggest low risk with standard handling; not known to be carcinogenic or mutagenic; overuse may contribute to antibiotic resistance
Sensitization: Allergic reactions such as urticaria or angioedema reported in sensitive individuals
Ecotoxicity: Harmful to aquatic life at moderate or high concentrations; avoid discharge to sewers or water systems
Persistence and Degradability: Not readily biodegradable; persistent in aquatic environments
Bioaccumulation Potential: Moderate potential; actual risk depends on local environmental conditions
Mobility in Soil: Moderately mobile; can leach depending on rainfall and soil composition
Waste Disposal Method: Dispose of in accordance with all local, regional, and national regulations
Preferred Disposal Options: Incineration in a licensed facility is safest; do not flush down drain
Disposal of Packaging: Empty containers may retain product residues; triple rinse, then dispose as hazardous waste
Special Precautions: Wear gloves and mask during handling and disposal; label waste containers clearly
UN Number: Not regulated for transport
Transport Hazard Class: Not classified as dangerous goods
Packing Group: Not assigned
Labels Required: None under standard shipping conditions
Additional Shipping Notes: Store securely during transport; prevent exposure to water, heat, and direct light
EU Regulation: Not classified as dangerous according to EC directives
US OSHA: Not listed as hazardous material
TSCA Status: Not listed; for research and prescription use only
Other International Regulations: Product falls under pharmaceutical control for specific jurisdiction; packaging and labeling requirements vary
Workplace Use: Consultation with occupational hygienists recommended for repeated or large-scale exposure; safety dossier should be maintained
