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Product Name: Cefcapene Pivoxil Hydrochloride
Chemical Name: (6R,7R)-7-{[(R)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino}-3-[(Z)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrochloride, 1-(carbonyloxy)ethyl ester
Molecular Formula: C19H22N6O7S2·HCl
Molecular Weight: 548.01 g/mol
SYNONYMS: Cefcapene pivoxil hydrochloride hydrate; Cefcapene pivoxil HCl
Recommended Use: Antibiotic for pharmaceutical preparation
Supplier Details: Manufacturer or distributor contact information required for emergency phone number and address on actual shipment
GHS Classification: Not classified as hazardous according to current legislation
Route of Entry: Inhalation, skin contact, eye contact, ingestion
Most Important Hazards: Allergic reactions, potential respiratory sensitization, risk of irritation to eyes and skin
Label Elements: None for end-user pharmaceutical products; bulk drug labels may require "Warning: May cause allergy."
Potential Health Effects: Hypersensitivity, potential renal impairment if significant exposure occurs occupationally
Cefcapene Pivoxil Hydrochloride: ~100%, Active Ingredient, CAS No: 119212-42-7
Hazardous Impurities: Not detected or below regulated thresholds for known significant hazards
Excipient Additives: None in API (active pharmaceutical ingredient) format, excipients found only in finished tablet or granule formulations
Inhalation: Move to fresh air, seek medical attention if symptoms persist, monitor for respiratory irritation
Skin Contact: Remove contaminated clothing, wash affected skin thoroughly with soap and water, obtain medical advice for persistent irritation or signs of allergy
Eye Contact: Rinse immediately with plenty of clean water for at least 15 minutes, consult ophthalmologist if discomfort continues
Ingestion: Rinse mouth, do not induce vomiting, obtain medical attention; bring material label or safety data to healthcare provider
Important Symptoms: Allergic reaction: rash, swelling, difficulty breathing; prompt action required if symptoms manifest
Suitable Extinguishing Media: Use carbon dioxide, dry chemical powder, foam or water spray (avoid direct high-pressure water jet)
Specific Hazards: Thermal decomposition releases toxic fumes including nitrogen oxides, sulfur oxides, hydrogen chloride
Protective Equipment: Full protective clothing and suitable breathing apparatus required
Special Procedures: Avoid inhalation of decomposition products, keep unauthorized personnel away
Personal Precautions: Avoid contact with skin and eyes, avoid raising dust, use respiratory protection if significant dusting occurs
Environmental Precautions: Prevent spillage from entering drains, soil, waterways
Containment: Ventilate area, clean up spills using non-sparking tools, absorb with inert material (sand, earth)
Cleanup Methods: Shovel into suitable closed and labeled containers for disposal
Handling: Operate in well-ventilated areas, use suitable PPE including gloves, goggles, and protective clothing, minimize dust formation
Storage: Store in original container, keep tightly closed, protect from light, store in a cool, dry place at room temperature, avoid humidity
Special Requirements: Segregate from incompatible substances such as strong acids and oxidizers, limit access to authorized personnel trained in proper pharmaceutical handling protocols
Engineering Controls: Handle in chemical fume hood where possible, provide local exhaust ventilation, use closed systems for large quantities
Personal Protective Equipment: Gloves resistant to chemicals, laboratory coat, eye protection or safety goggles, mask or particulate respirator if airborne concentrations exceed recommended exposure levels
Hygiene Measures: Wash hands thoroughly after handling, do not eat, drink, or smoke during use, remove contaminated clothing promptly
Occupational Exposure Limit: No specific OEL established for this compound; handle as a sensitizer or pharmaceutical allergen
Appearance: White or off-white crystalline powder
Odor: Odorless or faint characteristic odor
pH (solution): 3.5 – 5.5 (in water)
Solubility: Freely soluble in water, slightly soluble in methanol, insoluble in ether
Melting Point: Decomposes at >180°C
Partition Coefficient: Low log P value, expected low bioaccumulation
Stability: Stable under normal storage and handling conditions
Other Properties: Non-flammable, non-volatile, forms dust in solid form
Chemical Stability: Stable under recommended storage conditions, light sensitive, hydrolyzes in presence of water
Conditions to Avoid: Excessive heat, moisture, ultraviolet or direct sunlight
Materials to Avoid: Strong acids, bases, oxidizing agents
Hazardous Decomposition Products: Fumes of nitrogen oxides, sulfur oxides, hydrogen chloride under fire conditions
Reactivity: Low under normal handling; degradation increases with pH irregularity, heat, or light exposure
Acute Toxicity: LD50 (oral, rodents) not well established in public data, expected low acute toxicity at therapeutic doses
Potential Health Effects: Sensitization possible after skin contact, rare risk of severe allergic reaction
Symptoms of Overexposure: Allergic skin reactions, gastrointestinal upset, rare renal or hepatic adverse effects if grossly misused
Carcinogenicity, Mutagenicity, Reproductive Toxicity: No evidence for genotoxicity or carcinogenicity in animal studies; standard restrictions for pregnant or breastfeeding individuals apply based on antibiotic class precautions
Ecotoxicity: Expected low environmental toxicity at pharmaceutical levels, large-scale spills may pose risk to bacteria or aquatic organisms
Mobility: Water soluble, may leach extensively if released in significant quantity
Persistence and Degradability: Expected to degrade by hydrolysis and microbial activity over moderate timeframes
Bioaccumulative Potential: Low, based on physicochemical properties and typical metabolic pathways
Further Remarks: Minimize environmental exposure, avoid discharging active pharmaceutical ingredients into surface or ground water
Disposal Methods: Incinerate in a chemical incinerator conforming to local regulations, do not discharge into waterways
Contaminated Packaging: Dispose of as hazardous pharmaceutical waste, rinse thoroughly before recycling or landfill if regulations allow
Precautions: Follow national, regional, and local regulations regarding pharmaceutical waste, do not reuse empty containers for other materials
UN Number: Not regulated as a dangerous good for transport under UN, ICAO, IMO, or ADR
Proper Shipping Name: Cefcapene Pivoxil Hydrochloride, pharmaceutical product
Transport Hazard Class: Not classified as hazardous
Packing Group: Not applicable
Further Information: Ensure packaging prevents exposure, damage and leakage, label packages clearly for traceability during shipping
Global Chemical Inventory: Not typically listed in general chemical inventories due to pharmaceutical use
Labelling: Not subject to global chemical hazard labelling in finished drug form, raw material labeling may reflect irritant or sensitizer risk
Other Regulatory Status: Pharmaceutical use complies with local health authority regulation, manufacturing and handling governed by GMP and pharmaceutical regulation
Worker Safety: Standards for occupational safety mandated by local occupational health and safety law, physician oversight for exposed personnel recommended
