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Product Name: Cloxacillin Sodium
Chemical Formula: C19H18ClN3NaO5S
Synonyms: Cloxacillin monosodium salt, Cloxacillin sodium salt
CAS Number: 642-78-4
Recommended Use: Pharmaceutical raw material, antibiotic for medical preparations
Manufacturer: Supplied by pharmaceutical companies and chemical distributors worldwide
Emergency Contact: Consult manufacturer or local Poison Control Center for immediate assistance
Classification: Not classified as hazardous under GHS or OSHA regulations for transport and general handling in typical pharmaceutical environments
Acute Health Hazards: May cause irritation to eyes, skin, and respiratory system; Allergic responses possible in sensitive or exposed individuals
Chronic Health Hazards: Potential for allergic sensitization in repeated exposure; Rare chance of nephritis, blood disorders with long-term and repeated contact
Label Elements: Exclamation mark symbol indicating possible allergenic and irritant effects
Precautionary Statements: Wash hands after handling; Avoid direct exposure; Wear protective equipment at all times
Chemical Name: Cloxacillin Sodium
Concentration: 100% (active ingredient in commercially pure products)
Chemical Family: Beta-lactam antibiotic, penicillin derivative
Impurities: Pharmaceutical grades typically contain less than 1% related substances and impurities, considered pharmacologically inactive
Molecular Weight: 476.87 g/mol
Eye Contact: Immediately flush with clean water for at least 15 minutes, keeping eyelids open; seek medical attention for redness, irritation or persistent discomfort
Skin Contact: Remove contaminated clothing, rinse skin thoroughly with soap and water; medical advice recommended for skin irritation or allergic response
Inhalation: Move affected person to fresh air; seek medical evaluation if respiratory distress or allergic symptoms develop
Ingestion: If accidentally swallowed, rinse mouth with water; do not induce vomiting unless instructed by medical personnel, seek medical attention due to potential toxicity
Notes for Physician: Treat symptomatically; known allergic reactions should be addressed with antihistamines or corticosteroids if required
Suitable Extinguishing Media: Water spray, dry chemical powder, carbon dioxide, or foam; use media appropriate for surrounding fire
Specific Hazards: Combustion can produce toxic fumes including carbon monoxide, carbon dioxide, nitrogen oxides, hydrogen chloride, sodium oxides, and sulfur oxides
Protective Equipment: Firefighters should wear self-contained breathing apparatus and protective clothing to avoid inhalation of fumes
Special Procedures: Prevent run-off into drains or water courses; cool any exposed containers with water spray to avoid pressure buildup and rupture
Personal Precautions: Use appropriate PPE including gloves, goggles, and dust mask; avoid raising dust
Environmental Precautions: Prevent product or run-off from entering drains, waterways, or uncontrolled soil
Clean-up Methods: Sweep or vacuum up material using equipment fitted with a HEPA filter; avoid dry sweeping that may generate dust; place residue in sealed, labeled containers for destruction as hazardous waste; wash spill site after material pick-up is complete
Handling: Wear PPE such as lab coat, safety goggles, and suitable gloves; avoid unnecessary contact with product and the generation of dust; wash hands and exposed skin before eating or drinking
Storage: Store in a cool, dry place away from sources of heat or ignition and direct sunlight; keep container tightly closed when not in use; protect from moisture and incompatibles such as strong acids and oxidizers; follow storage instructions as per pharmaceutical grade storage conditions
Control Parameters: No specific occupational exposure limit values established for cloxacillin sodium; general nuisance dust limits (OSHA PEL: Total Dust 15 mg/m³, Respirable Dust 5 mg/m³)
Ventilation: Operate within well-ventilated areas or laboratory fume hoods; engineering controls should reduce airborne concentrations
Personal Protective Equipment (PPE): Nitrile or latex gloves, chemical goggles, laboratory coat, dust mask (N95 or appropriate filter respirator during dust-generating procedures); avoid unprotected contact with eyes, skin, and respiratory tract
Appearance: White to off-white, crystalline powder
Odor: Odorless or faintly medicinal
Odor Threshold: No data available
pH (1% aqueous solution): 5.0–7.5
Melting Point: Decomposes before melting
Boiling Point: Not applicable
Solubility: Freely soluble in water; practically insoluble in alcohol, chloroform, ether
Partition Coefficient (log Kow): No data available
Vapor Pressure: Negligible
Density: 1.54 g/cm³ (approximated)
Flash Point: Not combustible
Evaporation Rate: Not applicable
Other: Stable under recommended storage conditions
Chemical Stability: Stable under normal and recommended storage and handling conditions; light or prolonged exposure to heat or moisture causes degradation
Hazardous Reactions: Does not readily undergo hazardous polymerization
Incompatible Materials: Strong oxidizing agents, strong acids; contact may result in decomposition, loss of potency or hazardous byproducts
Decomposition Products: Emits toxic fumes of CO, CO2, HCl, NOx, and SOx when burned or decomposed at high temperature
Acute Toxicity: Low acute oral toxicity in animal studies; oral LD50 for mice >5 g/kg; inhalation or skin absorption lower hazard except in allergic or sensitive individuals
Skin and Eye Contact: Causes irritation; repeated contact may produce dermatitis or allergic response
Inhalation: Dust may cause respiratory tract irritation, coughing, sneezing
Ingestion: Nausea, vomiting, diarrhea, allergic reactions possible
Chronic Effects: Sensitization leading to severe allergic reactions (rash, fever, anaphylaxis in rare cases); kidney and blood effects only at high or repeated overexposure
Carcinogenicity: Not classified as carcinogen by IARC, ACGIH, NTP, or OSHA
Mutagenicity: No mutagenicity observed in standard in vitro and in vivo genotoxicity tests
Reproductive Toxicity: No studies indicating reproductive hazards with normal handling in pharmaceutical manufacturing settings
Aquatic Toxicity: Avoid large releases; antibiotics can disrupt natural microbial communities; data for cloxacillin sodium shows low acute aquatic toxicity, but environmental persistence can affect wastewater treatment if quantities are high
Persistence and Degradability: Degrades over time in natural waters, but chronic low-level presence may contribute to antimicrobial resistance in environment
Bioaccumulation: Not expected to bioaccumulate significantly based on chemical structure and water solubility
Mobility in Soil: Water soluble, so may move through soil to groundwater if released in bulk
Other Adverse Effects: Meets criteria for “pharmaceutical active substance” precaution in pharmaceutical waste and process water
Waste Disposal: Collect material in sealed, labeled containers; follow state and federal regulations on pharmaceutical waste disposal; recommended incineration at approved facility
Container Disposal: Rinse containers before controlled disposal; do not release residues into surface water or sewage
Precautions: Treat waste as hazardous due to pharmaceutical activity even if non-listed; always follow institutional protocol and consult local environmental authorities
Unused Product: Return to manufacturer or authorized waste processor if feasible
UN Number: Not regulated for transport as a dangerous good
Proper Shipping Name: Cloxacillin Sodium, not otherwise specified
Transport Hazard Class: Not classified
Packing Group: Not applicable
Special Transport Precautions: Ship in securely closed containers; keep dry and avoid rough handling to prevent package rupture
Transport Labeling: Not required by major international or US domestic transport regulations
US Regulations: Not regulated under SARA Title III sections 302, 304, or 313; not a hazardous chemical as defined by OSHA Hazard Communication Standard
TSCA Status: Exempt for pharmaceutical intermediate uses
EU Regulations: Not listed under REACH substances of very high concern, classified under medicinal products rather than industrial chemicals
WHMIS (Canada): Not controlled under WHMIS
Other Regulations: Compliance required with FDA or EMA regulations for pharmaceutical manufacturing; consult respective countries’ environmental discharge guidelines for pharmaceuticals
