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Material Safety Data Sheet (MSDS) – Clarithromycin

Identification

Product Name: Clarithromycin
Chemical Formula: C38H69NO13
Synonyms: 6-O-Methylerythromycin A
Relevant Identified Uses: Pharmaceutical intermediate, antibiotic agent for treatment of respiratory tract infections, skin infections, and Helicobacter pylori eradication
Manufacturer: Abbott Laboratories
Contact for Detailed MSDS: Emergency response number typically listed by local manufacturer or distributor
Recommended Restrictions: Restricted to prescription use; healthcare personnel and qualified handlers only
CAS Number: 81103-11-9

Hazard Identification

GHS Classification: Acute Toxicity (Oral, Category 4), Specific Target Organ Toxicity (Single Exposure, Category 3)
Pictogram: Exclamation mark
Signal Word: Warning
Hazard Statements: May cause respiratory irritation, may cause allergy or asthma symptoms by inhalation, harmful if swallowed
Precautionary Statements: Avoid breathing dust, wash hands thoroughly after handling, use only outdoors or in well-ventilated areas
Potential Health Effects: Inhalation causes shortness of breath or irritation, ingestion leads to gastrointestinal disturbances, skin or eye contact results in mild irritation
Environmental Hazard: Harmful to aquatic organisms, avoid release to the environment

Composition / Information on Ingredients

Substance: Clarithromycin
Concentration: ≥98% in pure form (formulated products vary)
Impurities: Erythromycin derivatives, residual solvents below pharmacopoeial limits
Other Components: Excipients present in pharmaceutical preparations, such as microcrystalline cellulose, magnesium stearate, povidone K30, lactose monohydrate in variable proportions depending on dosage form

First Aid Measures

Inhalation: Remove person to fresh air, seek medical attention if symptoms persist
Skin Contact: Wash area thoroughly with soap and water, remove contaminated clothing, consult physician in case of irritation
Eye Contact: Rinse cautiously with water for several minutes, seek medical advice if irritation develops
Ingestion: Rinse mouth with water; do not induce vomiting unless directed by medical personnel, get immediate medical assistance

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, alcohol-resistant foam
Specific Hazards: Combustion produces toxic fumes such as carbon oxides and nitrogen oxides
Special Protective Equipment for Firefighters: Use self-contained breathing apparatus, protective clothing, avoid inhaling smoke or dust

Accidental Release Measures

Personal Precautions: Wear gloves, mask, protective eyewear
Environmental Precautions: Prevent runoff into sewers, soil, or waterways
Methods for Cleanup: Sweep up carefully without generating dust, place in suitable sealed containers for disposal, clean spill site with detergent and water

Handling and Storage

Precautions for Safe Handling: Handle under well-ventilated conditions, avoid dust formation, keep away from incompatible substances such as strong oxidants
Storage Conditions: Store in tight, light-resistant containers, keep away from moisture and direct sunlight, maintain temperature between 15–30°C
Incompatible Materials: Strong acids, strong bases, strong oxidizing agents

Exposure Controls and Personal Protection

Engineering Controls: Operate under fume hood or local exhaust ventilation in laboratory settings
Respiratory Protection: NIOSH-approved particulate respirator for airborne dust
Skin Protection: Chemical-resistant gloves such as nitrile
Eye Protection: Safety goggles or face shield
General Hygiene: Avoid direct contact with skin and eyes, do not eat or drink during handling, wash thoroughly after exposure

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless or slight characteristic odor
Molecular Weight: 747.95 g/mol
pH (1% solution): 7–9
Melting Point: 220–230°C
Solubility: Slightly soluble in water, freely soluble in methanol and acetonitrile, sparingly soluble in acetone
Partition Coefficient (log P): 3.16 (octanol/water)
Vapor Pressure: Not applicable; negligible at room temperature
Boiling Point: Not applicable under atmospheric pressure
Flash Point: Not determined; solid powder

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Reactivity: No dangerous reactions under normal handling
Possible Hazardous Reactions: Reacts with strong acids or oxidizers to form hazardous decomposition products
Decomposition Products: Toxic gases including carbon monoxide, carbon dioxide, nitrogen oxides
Conditions to Avoid: Exposure to light, heat, moisture, and incompatible substances

Toxicological Information

Acute Toxicity Data (Oral, rat): LD50 ~2000 mg/kg
Potential Effects: Ingestion may cause nausea, vomiting, diarrhea, abdominal pain, hypersensitivity reactions, and taste disturbances
Chronic Effects: Liver function disturbances, hearing loss at high or prolonged doses
Carcinogenicity: Not listed as carcinogenic by IARC, NTP, or OSHA
Sensitization: May cause skin or respiratory sensitization in susceptible individuals
Mutagenicity: No evidence from animal studies
Target Organs: Liver, gastrointestinal tract, auditory system

Ecological Information

Ecotoxicity: May cause long-term adverse effects in the aquatic environment; avoid release
Persistence and Degradability: Moderately persistent, slow biodegradation in soil and water
Bioaccumulative Potential: Low; not expected to bioaccumulate in aquatic organisms
Mobility in Soil: Low mobility, binds to organic matter
Other Adverse Effects: May disrupt the microbial balance in sewage treatment; contributes to development of antimicrobial resistance in natural water sources

Disposal Considerations

Waste Disposal Methods: Dispose in accordance with local, regional, and national regulations; do not flush into water supply or normal waste systems
Incineration: Preferred route using high temperature incinerators equipped with scrubbers for hazardous pharmaceuticals
Packaging Disposal: Treat as hazardous pharmaceutical waste; clean or destroy containers to prevent environmental contamination

Transport Information

UN Number: Not regulated for transport under UN, IMDG, IATA
Proper Shipping Name: Not classified as dangerous goods
Transport Hazard Class: None
Packing Group: None
Special Precautions: Protect containers from physical damage; ensure packaging is intact to prevent leaks; keep product away from moisture and incompatible items during transit

Regulatory Information

US Regulations: Not classified as hazardous under OSHA Hazard Communication Standard (29 CFR 1910.1200); listed as a prescription drug by the FDA
EU Regulations: Classified as a prescription-only medicine, follows CLP Regulation (EC) No. 1272/2008
Canadian Regulations: Controlled under Food and Drugs Act, available by prescription
Environmental Legislation: Subject to wastewater discharge regulations and pharmaceutical take-back programs; product labeling includes environmental disposal warnings
Other International Regulations: Registered as active pharmaceutical ingredient in many health authorities, not classified as a controlled substance under UN Conventions