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Product Name: Ertapenem Sodium
Synonyms: Ertapenem disodium salt
Chemical Formula: C22H23N3O7S·Na
CAS Number: 153832-46-3
Intended Use: Pharmaceutical ingredient
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GHS Classification: Acute toxicity (oral, dermal, inhalation), skin sensitization
Label Elements: Hazard pictogram: Exclamation Mark; Signal word: Warning
Hazard Statements: May cause allergy or asthma symptoms, breathing difficulties, may cause skin and respiratory irritation, possible allergic reactions.
Precautionary Statements: Avoid breathing dust, wear protective gloves and eye protection, wash exposed area thoroughly after handling, avoid release to environment.
Chemical Name: Ertapenem sodium
Concentration: >95% by weight
Other Ingredients: No significant impurities expected with normal use
Molecular Weight: ~497.5 g/mol
Inhalation: Move exposed person to fresh air, support breathing as necessary, seek immediate medical attention for persistent symptoms.
Skin Contact: Wash skin thoroughly with soap and water, remove contaminated clothing, seek medical attention if irritation or allergic reaction develops.
Eye Contact: Rinse immediately with plenty of water for at least 15 minutes, keep eyelids open, consult physician.
Ingestion: Rinse mouth with water, seek medical advice, do not induce vomiting unless directed by a medical professional.
Most important symptoms: Allergic reactions, skin irritation, respiratory issues, gastrointestinal effects.
Note to Physicians: Treat symptomatically, monitor for delayed allergic responses.
Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical, foam.
Unsuitable Extinguishing Media: None identified under typical conditions.
Specific Hazards: Dust may form explosive mixture with air, combustion can produce oxides of carbon, nitrogen, and sulfur.
Fire-fighter Protection: Wear self-contained breathing apparatus and full protective gear.
Special Instructions: Move containers from fire area if safe, use water to keep containers cool, avoid inhaling smoke or fumes.
Personal Precautions: Wear recommended protective equipment, avoid inhaling dust, isolate area and prevent unnecessary access.
Methods for Cleanup: Use non-sparking tools, minimize dust formation, sweep up material and place in suitable closed containers for disposal.
Environmental Precautions: Avoid discharge into drains, water courses, or soil, notify local authorities if large releases occur.
Decontamination: Wipe down surfaces with damp cloth or appropriate cleaning products to remove traces.
Handling: Handle in well-ventilated area, avoid inhaling dust and direct contact with skin or eyes, use only with suitable local exhaust ventilation, avoid eating or drinking while handling.
Storage Conditions: Store in a tightly closed original container away from light, moisture, and incompatible substances, recommended storage temperature is 2-8°C, avoid storage under damp or humid conditions.
Incompatibilities: Strong oxidizing agents, acids, and bases.
Other Precautions: Keep away from food products, access restricted to trained personnel.
Occupational Exposure Limits: No specific OSHA or ACGIH limit established, follow good industrial hygiene practices.
Engineering Controls: Use local exhaust ventilation to control dust, process enclosures recommended for high-volume operations.
Personal Protection: Wear impermeable gloves (nitrile preferred), long sleeve protective clothing, safety goggles, and dust filtering respirator as needed, wash hands thoroughly after use.
Environmental Controls: Avoid environmental release, use containment systems, regularly inspect ventilation and control devices.
Appearance: White to off-white crystalline powder
Odor: Odorless
pH: 4.0-5.5 (1% aqueous solution)
Melting Point: Data not available; degrades before melting
Boiling Point: Not applicable
Solubility: Freely soluble in water, slightly soluble in alcohol
Vapor Pressure: Not expected at standard temperature
Density: ~1.3 g/cm³
Partition Coefficient (n-octanol/water): Not determined
Other Properties: Sensitive to light and moisture, stable under recommended conditions.
Chemical Stability: Stable in original packaging under recommended storage conditions.
Instability: Decomposes under extreme heat, moisture, and light.
Reactivity: Not reactive under normal practices.
Hazardous Decomposition Products: Thermal decomposition may generate carbon monoxide, carbon dioxide, nitrogen oxides, sulfur oxides.
Incompatibilities: Strong acids, strong bases, oxidants.
Polymerization: No hazardous polymerization expected.
Potential Health Effects: May cause skin and eye irritation, respiratory tract irritation upon inhalation, possible allergic skin and respiratory reactions, rare hepatobiliary effects in susceptible individuals.
Acute Toxicity: Oral LD50 (rat): >2000 mg/kg; may vary for different species.
Chronic Effects: Repeated or prolonged occupational exposure may lead to increased risk of sensitization or allergies.
Carcinogenicity: Not classified as carcinogen by IARC, NTP, or OSHA.
Mutagenicity: Genetic toxicity testing does not show significant risk.
Reproductive Toxicity: No developmental toxicity reported in animal studies, standard pharmaceutical precautions recommended.
Other Effects: Some individuals with beta-lactam sensitivity may exhibit cross-reactivity.
Ecotoxicity: No extensive ecological testing data available; avoid uncontrolled environmental release.
Persistence and Degradability: Expected to undergo degradation under environmental conditions with microbial action.
Bioaccumulation: Low potential for bioaccumulation based on molecular properties.
Mobility in Soil: Product dissolves easily in water, can leach into groundwater if released in significant amounts.
Other Adverse Effects: Large-scale contamination may disrupt microbial processes in water or soil.
Waste Handling: Dispose of unused or expired product as hazardous pharmaceutical waste per local, regional, or national regulations.
Methods of Disposal: Incinerate in a permitted hazardous waste facility; do not allow into drains or environment.
Contaminated Packaging: Clean containers before disposal, discard containers in accordance with official regulations.
Precautions: Personnel must be trained and wear appropriate protective equipment during disposal.
UN Number: Not regulated under international transport rules for pharmaceuticals
Proper Shipping Name: Pharmaceutical chemicals, solid, not otherwise specified
Transport Hazard Class: Not classified as dangerous under ADR/RID, IMDG, or IATA
Packing Group: Not assigned
Special Precautions: Secure packaging to prevent breakage or spillage during transport, protect from moisture and direct sunlight, transport according to good manufacturing and distribution practice.
Environmental Hazards: Not classified as marine pollutant.
TSCA Status: For research or pharmaceutical use, not listed for bulk chemicals
US Federal Regulations: Not subject to SARA Title III reporting; not specifically regulated as a hazardous substance under OSHA
EU Regulations: Not classified as hazardous under current REACH regulations for finished pharmaceutical use, consult local requirements
Other Regulations: Medical use governed by national pharmaceutical registration and licensing agency, follow regulations on occupational exposure and environmental impact.
Workplace Hazardous Material Information System (WHMIS) Classification: D2B—Toxic material causing other toxic effects (Canada)
Warnings: Intended for professional and industrial use, not for direct consumer sale.
