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Product Name: Ampicillin
Synonyms: D-(-)-α-Aminobenzylpenicillin, Penbritin
CAS Number: 69-53-4
Molecular Formula: C16H19N3O4S
Molecular Weight: 349.41 g/mol
Recommended Use: Pharmaceutical raw material; antibiotic
Manufacturer Information: Company details provided on request; Emergency contact number listed on shipment and supplied documentation
Relevant Identified Uses: Laboratory chemical and active component in pharmaceutical preparations
GHS Classification: Skin sensitizer (Category 1), Respiratory sensitizer (Category 1), Eye irritant (Category 2A)
Signal Word: Warning
Hazard Statements: May cause allergy or asthma symptoms or breathing difficulties if inhaled, may cause an allergic skin reaction, causes serious eye irritation
Precautionary Statements: Avoid breathing dust, wear protective gloves, clothing, and eye protection, in case of inadequate ventilation wear respiratory protection, wash thoroughly after handling
Pictograms: Exclamation mark, health hazard
Target Organs: Skin, respiratory system, eyes
Potential Health Effects: Allergic reactions, irritation to eyes and respiratory tract, skin rash
Component: Ampicillin sodium
Purity: Typically ≥98%
Chemical Identity: 6-[D(-)-α-Aminophenylacetamido] penicillanic acid monohydrate (for trihydrate form)
Impurities: Trace penicillin derivatives, moisture content as per certificate of analysis
Other Ingredients: No significant non-active fillers for raw substance
General Advice: Move away from exposure site, seek medical attention
Inhalation: Remove to fresh air, monitor for difficulty in breathing, get immediate medical support for respiratory symptoms
Skin Contact: Remove contaminated clothing, wash affected area thoroughly with soap and water, seek medical opinion for persistent symptoms
Eye Contact: Rinse for at least 15 minutes with plenty of water, occasionally lifting upper and lower eyelids; medical assessment strongly advised
Ingestion: Rinse mouth, do not induce vomiting without medical advice, seek attention if unwell
Self-Protection for First Responders: Use gloves and protective mask, avoid exposure to dust
Suitable Extinguishing Media: Use water spray, dry powder, foam, or carbon dioxide
Hazards from Combustion Products: Releases oxides of carbon, nitrogen, and sulfur; toxic fumes possible
Protective Equipment: Wear self-contained breathing apparatus and protective clothing
Specific Hazards: Fine powder may form explosive mixtures in air; product combustible at high temperatures
Special Procedures: Prevent runoff from entering drains or watercourses, clear area, ventilate closed spaces
Personal Precautions: Avoid inhalation and skin/eye contact, use respirator and gloves
Environmental Precautions: Prevent powder from entering sewers, surface water, or soil
Containment Methods: Sweep up with care to avoid dusting, use HEPA vacuum or wet methods if possible
Cleanup Procedures: Collect spillage in appropriate containers for disposal, decontaminate area with detergent, provide adequate ventilation during cleanup
Safe Handling Methods: Use in well-ventilated area, avoid creating dust clouds, do not eat, drink, or smoke when handling
Avoided Conditions: High heat, moisture, strong oxidizers
Hygiene Measures: Do not handle until all safety instructions are read, wash thoroughly after use, remove contaminated clothing
Storage Conditions: Store in tightly closed container in a cool, dry place; temperature typically 2–8°C recommended, avoid exposure to direct sunlight or humidity
Packaging Materials: Prefer airtight, break-resistant containers labeled clearly for pharmaceutical raw materials
Occupational Exposure Limits: No specific OSHA, NIOSH, or ACGIH limits for ampicillin. Follow general dust exposure limits (typically 10 mg/m³ for total dust, 3 mg/m³ for respirable fraction)
Engineering Controls: Utilize local exhaust ventilation, containment methods, fume hoods in laboratory settings
Personal Protective Equipment (PPE): Use disposable gloves, safety goggles, lab coat or apron, dust mask or NIOSH-approved respirator for high concentrations
Exposure Monitoring: Conduct regular monitoring in workplaces with frequent exposure, especially pharmaceutical manufacturing
Environmental Controls: Minimize dispersion in air, regular cleaning to avoid residue buildup
Appearance: White to off-white crystalline powder
Odor: Odorless or very faint smell
pH (solution): 8–10 (for 10% aqueous solution)
Melting Point: Decomposes, approximately 200°C
Solubility: Freely soluble in water, practically insoluble in most organic solvents (alcohol, chloroform, ether)
Boiling Point: Not applicable (decomposes before boiling)
Vapor Pressure: Negligible
Flash Point: Not determined
Partition Coefficient (log P): -2.5
Stability in Solution: Instability increases in acidic or alkaline conditions and in presence of moisture
Other Properties: Sensitive to light, may hydrolyze slowly on exposure to moisture
Chemical Stability: Stable under recommended storage conditions, decomposes with heat and moisture
Reactivity: Reacts with strong oxidizing agents and acids
Hazardous Decomposition Products: Yields toxic gases, including nitrogen oxides, sulfur oxides, and carbon monoxide, on thermal decomposition
Conditions to Avoid: Exposure to moisture, extreme heat, direct sunlight
Potential for Polymerization: Does not polymerize under normal storage and handling
Incompatibility: Strong acids, strong oxidizing agents; keep away from chlorinated disinfectants
Acute Toxicity: Oral LD50 (rat): >5000 mg/kg, low direct toxicity at normal exposure levels
Skin Corrosion/Irritation: May cause mild irritation or rash, especially in sensitive individuals
Serious Eye Damage/Irritation: Causes moderate to severe irritation on direct contact
Respiratory or Skin Sensitization: May cause allergic reactions in susceptible people; asthmatic symptoms possible
Germ Cell Mutagenicity: No evidence or mutagenicity in standard bacterial/mammalian cell assays
Reproductive Toxicity: No data indicating risk at occupational exposure, but medical antibiotics contraindicated in some stages of pregnancy
Carcinogenicity: Not listed by IARC, NTP, or OSHA as carcinogen
Repeated Dose Toxicity: Chronic exposure may cause allergic responses
Additional Notes: Therapeutic allergies to β-lactams common in medical literature
Ecotoxicity: High concentrations harmful to aquatic organisms, potential for development of antimicrobial resistance in microorganisms
Persistence and Degradability: Not readily biodegradable in natural conditions, decomposition slow in water and soil
Bioaccumulation Potential: Unlikely to bioaccumulate due to high water solubility and rapid degradation by hydrolysis over time
Mobility in Soil: Considerable, owing to solubility, but breakdown products present risk
Other Adverse Effects: Potential disruption of microbial ecosystems, caution required in pharmaceutical manufacturing wastewater
Waste Characteristics: Non-hazardous in small quantities, but active pharmaceutical waste regulations apply
Disposal Methods: Collect in sealed, labeled containers for pharmaceutical waste, destruction by incineration in licensed facility recommended
Special Precautions: Do not dispose in household garbage, avoid discharge to environment, conform to local regulations
Contaminated Packaging: Decontaminate before disposal or incinerate with contents if decontamination not feasible
UN Number: Not classified as hazardous for transport
Transport Hazard Class: Not restricted
Packing Group: Not applicable
Special Transportation Notes: Protect from moisture and extreme temperatures during shipment; secure cargo to prevent spillage
Labeling Requirements: Standard non-hazardous labeling, identify product and batch clearly
International Inventory Status: Listed in EU EINECS and US TSCA for research and pharmaceutical use
Safety Regulations: Subject to pharmaceutical GMP and worker protection standards; OSHA Hazard Communication Standard applies
Environmental Regulations: Discharges regulated under national/local water and pharmaceutical legislation
Major Restrictions: Medical use by prescription only, additional restrictions on large-scale storage and disposal
REACH/CLP/OSHA: Not classified as hazardous chemical for general commerce, but strict internal controls apply in pharma environments
Other Notes: Worker training required for safe handling, regular safety reviews in production settings
