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Product Name: Meropenem Trihydrate
Synonyms: 1-β-Methyl carbapenem-3-carboxylic acid, Merrem
CAS Number: 119478-56-7
Recommended Use: Broad-spectrum antibiotic for bacterial infections
Company Details: Manufacturer and Distributor names, office address, and customer support contact
Emergency Telephone: Designated poison control hotline and manufacturer emergency number
Product Code: Internal tracking identifier as per manufacturer
Classification: Not classified as hazardous under GHS, but can cause allergic reactions in sensitive persons
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Signal Word: Not applicable for normal workplace use, but warning for allergic individuals
Hazard Statements: Risk of serious allergic reactions, may cause mild irritation to eyes or skin
Precautionary Statements: Avoid inhalation of dust or powder forms, personal protective gear recommended
Pictograms: Exclamation mark symbol for irritation and sensitization concerns
Other Hazards: Risk of anaphylaxis in those with known carbapenem or beta-lactam allergies
Chemical Name: Meropenem Trihydrate
Purity: Typically greater than 98% active pharmaceutical ingredient
Molecular Formula: C17H25N3O5S•3H2O
Molecular Weight: 437.5 g/mol
Impurities: Trace amounts of related substances below threshold levels per compendial standards
Decomposition Products: Minor quantities of β-lactam byproducts, water, and carbon oxides
Inactive Ingredients: None in raw active substance; formulated medicines may include stabilizers or buffer agents
Eye Contact: Rinse immediately with copious amounts of water for at least 15 minutes, keep eyelids open; medical consultation for persistent symptoms
Skin Contact: Wash affected skin thoroughly with soap and water; remove contaminated clothing; seek medical attention if rash or irritation occurs
Inhalation: Move person to fresh air, monitor for respiratory symptoms; seek medical care if cough, difficulty breathing, or allergic symptoms develop
Ingestion: Rinse mouth with water; do not induce vomiting unless advised by poison control; seek prompt medical advice if significant quantity swallowed
Main Symptoms: Irritation, rash, shortness of breath, swelling of lips or eyes, rapid onset allergic reactions
Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, foam
Unsuitable Media: No specific limitations for Meropenem Trihydrate, but avoid high-pressure water for powder dispersal
Combustion Hazards: Decomposition produces toxic fumes such as carbon oxides, nitrogen oxides, sulfur oxides
Protective Equipment: Self-contained breathing apparatus and full protective clothing recommended
Special Procedures: Cool containers with water spray if exposed to fire conditions; prevent run-off from entering drains or waterways
Personal Precautions: Avoid dust formation, ventilate area, wear gloves, lab coat, safety goggles, and approved respirator for powder clean-up
Environmental Precautions: Prevent product entry to surface water, soil, and drainage systems
Containment: Dampen powder or gently sweep; collect into closed, labeled containers for disposal
Spill Clean-up Methods: Use non-sparking tools and minimize dust creation; wash area with water and detergent once clean-up is complete
Precautions for Safe Handling: Use in well-ventilated workspace or appropriate fume hood, avoid inhaling powder or dust, wash hands after use, avoid direct skin and eye contact, restrict access to trained personnel
Storage Conditions: Store in tightly closed containers, away from light, heat, and moisture; temperature control below 25°C recommended
Incompatibilities: Avoid strong oxidizing agents, acids, and bases; separate from food and animal feed
Special Handling Instructions: No smoking, eating, or drinking in handling area; avoid mechanical shock or crushing containers
Exposure Limits: No established occupational exposure limits for Meropenem Trihydrate; minimize exposure consistent with good industrial hygiene
Engineering Controls: Local exhaust ventilation, chemical fume hood use recommended
Personal Protective Equipment: Safety goggles, gloves (nitrile or latex), lab coat, respiratory protection for large-scale or dusty conditions
General Hygiene: Wash hands after handling and before food or drink; avoid contact lenses during use; remove contaminated clothing before leaving work area
Appearance: White to off-white crystalline powder
Odor: Odorless or faint sulfur-like odor
pH (in solution): Approximately neutral (pH 6-8)
Melting Point: Decomposes above 120°C
Solubility: Soluble in water; low solubility in most organic solvents
Partition Coefficient (log Kow): Not applicable to this compound
Vapor Pressure: Non-volatile
Stability in Light: Sensitive to direct ultraviolet and visible light exposure, degrades over time
Boiling Point, Flash Point: Not applicable due to decomposition before boiling
Chemical Stability: Stable under normal conditions, rapidly degrades under high heat, acidic or alkaline conditions
Reactivity Hazards: Hydrolyzes in solution above neutral pH or in presence of strong bases/acids
Hazardous Decomposition Products: Emits carbon monoxide, carbon dioxide, nitrogen oxides, sulfur oxides under combustion or decomposition
Incompatible Materials: Strong acids, bases, oxidizers
Polymerization: No known hazardous polymerization risk
Acute Toxicity: Low acute oral, dermal, and inhalational toxicity in animal studies; LD50 (oral, rat) above 5000 mg/kg
Skin and Eye Effects: Mildly irritating to skin and eyes; cannot be excluded for sensitization reactions
Respiratory Effects: Sensitization and allergic responses such as asthma, rhinitis in sensitized individuals
Chronic Toxicity: No evidence of significant chronic toxicity in preclinical studies at therapeutic dose range
Carcinogenicity/Mutagenicity: No data indicating carcinogenic or mutagenic effects
Reproductive Toxicity: No signs in animal studies at tested dose levels
Most Probable Symptoms: Allergic skin reactions, urticaria, fever, respiratory difficulty, anaphylaxis in severe cases
Ecotoxicity: Low predicted toxicity to aquatic organisms; not expected to accumulate in environment under normal use
Environmental Fate: Readily biodegradable, but persistence possible if large quantities released
Bioaccumulation Potential: Low, based on structure and solubility
Mobility in Soil: High water solubility enables migration through soil, but rapid breakdown likely
Degradation: Hydrolyzes in sewage treatment and rapidly deactivates by microbial action
Proper Disposal Prevents Environmental Release: Follow pharmaceutical disposal programs or incineration
Product Disposal: Dispose as pharmaceutical waste by authorized incineration; avoid landfill or sewer discharge
Contaminated Packaging: Rinse thoroughly, then dispose with licensed chemical waste contractor
Disposal Guidance: Comply with local, regional, and national regulations regarding antibiotics; do not allow into natural watercourses
Incineration Methods: Controlled, high-temperature incineration for full decomposition
UN Number: Not assigned for this product, not classified as hazardous by transport regulations
Proper Shipping Name: Not regulated
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Label Requirements: No hazard label required
Other Transport Information: Protect from moisture and excessive heat; avoid direct sunlight during transit; follow good distribution practices for pharmaceuticals
International Regulations: Active ingredient approved by major health regulatory agencies for prescription use, subject to prescription controls
National Inventory: Not listed as a hazardous chemical in global chemical inventories (TSCA, EINECS, DSL, AICS, etc.)
OSHA Status: Not hazardous according to U.S. OSHA; handle with pharmaceutical caution
Control Status: Subject to pharmaceutical controls and prescription regulations; restricted for manufacturing and compounding use
Safety Review: Requires continued vigilance for allergic and environmental sensitivity risks
Other Notable Rules: Observe REACH, WHMIS, and transport safety guidelines for workplace handling and waste disposal
