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Material Safety Data Sheet for Penicillin V Potassium

Identification

Product Name: Penicillin V Potassium
Chemical Name: Benzylpenicillin Potassium Salt
Synonyms: Phenoxymethylpenicillin Potassium, Pen-Vee K, Veetids
CAS Number: 132-98-9
Molecular Formula: C16H17KN2O5S
Recommended Use: Antibacterial drug for the treatment of bacterial infections
Supplier Information: Manufacturing facility or pharmaceutical supplier details required
Emergency Contact: Local poison control center or supplier’s emergency number
Product Code: Specific supplier or internal identifier

Hazard Identification

Classification: Skin sensitizer (Category 1), May cause allergic reactions, Respiratory sensitizer (Category 1)
Signal Word: Warning
Hazard Statements: May cause an allergic skin or respiratory reaction, Harmful if swallowed in large quantities
Pictogram: Exclamation mark symbol
Routes of Exposure: Inhalation, skin contact, ingestion, eye contact
Symptoms: Allergic reactions such as rash, difficulty breathing, eye irritation, or swelling
Risks: Workers with penicillin hypersensitivity face a higher risk of severe reactions

Composition / Information on Ingredients

Active Ingredient: Penicillin V Potassium
CAS Number: 132-98-9
Concentration: Usually over 95% in pure substance; pharmaceutical products contain varying mixes with excipients
Impurities: May include minor degradation products, excipients in formulated tablets, and inert fillers
Other components: Starch, microcrystalline cellulose, magnesium stearate, and other pharmaceutical excipients may be present depending on the product’s form

First Aid Measures

Inhalation: Move person to fresh air and keep at rest, seek immediate medical attention if symptoms appear
Skin Contact: Remove contaminated clothing, wash affected area thoroughly with soap and water, consult physician for persistent irritation or allergic response
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present, seek medical advice if irritation persists
Ingestion: Rinse mouth with water; do not induce vomiting unless directed by medical personnel, seek immediate medical attention for allergic symptoms or if large amount swallowed
Note for Physicians: Individuals may have penicillin allergy history and risk of severe anaphylactic reaction

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, carbon dioxide, dry chemical powder, or foam
Specific Hazards: Combustion may generate carbon oxides, nitrogen oxides, sulfur oxides, potassium oxides
Protective Equipment: Firefighters should wear full protective gear and self-contained breathing apparatus
Advice: Keep containers cool with water spray to prevent pressure build-up, avoid breathing in any fire fumes

Accidental Release Measures

Personal Precautions: Wear personal protective equipment including gloves, lab coat, and NIOSH-approved respirator when dealing with powder
Environmental Precautions: Prevent spill from entering drains, surface water, or soil
Cleanup Methods: Sweep up material while avoiding dust formation, place in a sealed and labelled waste container for proper disposal, ventilate affected area
Decontamination: Wash contaminated area with plenty of water and ensure site is free from residue

Handling and Storage

Handling: Use in a well-ventilated area, avoid inhaling dust or contact with skin and eyes, wash hands after use
Precautions: Individuals with known penicillin allergies should not handle the product, practice good hygiene to prevent accidental contact
Storage: Store in a tightly closed container, keep in a cool, dry, well-ventilated place, protect from light and heat sources
Incompatibilities: Avoid storage with strong acids, bases, oxidizing agents, or moisture

Exposure Controls and Personal Protection

Exposure Limits: No specific occupational exposure limit established, though minimize risk from dust
Engineering Controls: Use local exhaust or fume hood for handling powder forms, maintain general area ventilation
Personal Protection: Wear disposable nitrile gloves, safety goggles, and lab coat
Respiratory Protection: Use NIOSH-approved respirator if dust is generated
Hygiene Measures: Remove contaminated clothing, wash hands before eating, drinking, or smoking, shower after significant exposure

Physical and Chemical Properties

Appearance: White to off-white crystalline or powder
Odor: Odorless or slightly odoriferous
pH (solution): Approximately 6.0-7.5 (for a 10% solution)
Melting Point: 176-185 °C
Solubility: Soluble in water, practically insoluble in chloroform or ether
Boiling Point: Not applicable (decomposes)
Density: 1.75 g/cm³ (approximate)
Partition coefficient: Log P value low, water soluble
Flash Point: Not flammable in normal conditions
Vapor Pressure: Negligible at ambient temperature

Stability and Reactivity

Chemical Stability: Stable when stored under recommended conditions
Decomposition: Degrades in presence of acids, alkalis, heat, and light
Incompatible Materials: Strong oxidizing agents, acids, alkalies
Hazardous Reactions: May form toxic gases such as sulfur oxides, nitrogen oxides, carbon monoxide upon combustion
Polymerization: Does not undergo hazardous polymerization

Toxicological Information

Acute Toxicity: LD50 (oral, rat): >5000 mg/kg, low toxicity for most people except those with allergies
Chronic Effects: Repeated exposure can lead to sensitization and allergic reaction
Symptoms: Rash, urticaria, anaphylaxis, asthma, gastrointestinal effects
Carcinogenicity: No evidence in animal studies or human use
Mutagenicity: Not considered genotoxic by published studies
Reproductive Effects: No adverse reproductive or developmental effects in studies
Target Organs: Immune system in sensitized individuals

Ecological Information

Ecotoxicity: Antibiotics may cause adverse effects on aquatic organisms, disrupt microbial activity, and contribute to antibiotic resistance
Persistence and Degradability: Not readily biodegradable, may persist in water and soil
Bioaccumulation Potential: Low potential due to low log P value
Mobility in Soil: Expected to be mobile in aqueous environments
Other Adverse Effects: Environmental exposure could influence microbial ecosystem balance and resistance patterns

Disposal Considerations

Product Disposal: Dispose of unused material as pharmaceutical waste in accordance with local, regional, and national regulations
Contaminated Packaging: Dispose in accordance with environmental safety guidelines
Special Instructions: Do not discharge into drains or environment, incinerate in a controlled facility
Waste Code: Varies by region; proper pharmaceutical waste disposal required

Transport Information

UN Number: Not regulated under standard UN numbers for hazardous material
Proper Shipping Name: Penicillin V Potassium, non-hazardous for roadway/air/sea transport in most jurisdictions
Hazard Class: Not classified as hazardous
Packing Group: Not applicable
Labels Required: None for general transport, unless otherwise specified by local regulation
Special Precautions: Avoid large scale spills during loading and unloading

Regulatory Information

Status: Prescription drug substance under regulatory control
OSHA: No defined occupational standard, treat as sensitizer
TSCA: Exempt as a pharmaceutical
EU: Listed on EINECS, classified as a skin and respiratory sensitizer
Other Regulations: Subject to FDA, EMA, and other national pharmaceutical regulations
Labeling Requirements: Allergen and sensitizer information required on packaging and workplace labeling
Restrictions: Only to be handled by trained personnel using personal protective equipment