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Material Safety Data Sheet: Paromomycin Sulfate

1. Identification

Product Name: Paromomycin Sulfate
Chemical Formula: C23H47N5O18 • H2SO4
CAS Number: 25389-09-9
Recommended Use: Pharmaceutical ingredient, mainly as an aminoglycoside antibiotic
Manufacturer: [Manufacturer Information]
Contact Information: [Manufacturer Emergency Telephone Number and Address]
Synonyms: Aminosidin sulfate, Monomycin sulfate
Emergency Overview: White to off-white powder, odorless; used in medical and laboratory settings for antibacterial applications.

2. Hazard Identification

Classification: Not classified as a hazardous substance under GHS.
Label Elements: No pictogram or hazard signal word required for most applications.
Hazard Statements: May cause skin and eye irritation. Overexposure through ingestion or prolonged contact can lead to allergic reactions or nephrotoxic effects. Risk increases through inhalation, skin absorption, or accidental ingestion.
Precautionary Statements: Avoid dust formation. Use only in well-ventilated areas. Wear protective equipment; keep out of reach of children and untrained personnel.

3. Composition / Information on Ingredients

Chemical Name: Paromomycin sulfate
Concentration: ≥98% (bulk pharmaceutical form)
Impurities: Water content less than 10%, minor process-related impurities under regulatory limits
Ingredient Type: Active pharmaceutical ingredient
Molecular Weight: 711.7 g/mol (paromomycin base), variable including sulfate
Contaminants: None expected above regulatory thresholds for pharmaceutical-grade material.

4. First Aid Measures

General Guidelines: Call emergency medical services for severe exposure. Remove source of contamination.
Inhalation: Move person to fresh air. Seek medical advice if symptoms such as shortness of breath, coughing, or dizziness develop. Monitor for respiratory distress.
Skin Contact: Take off contaminated clothing. Rinse skin with soap and plenty of water. Contact healthcare provider if irritation develops or persists.
Eye Contact: Rinse eyes with gentle stream of water for at least fifteen minutes, holding eyelids open. Medical attention is recommended if discomfort continues.
Ingestion: Rinse mouth thoroughly with water. Never induce vomiting without guidance from a poison center. Seek medical assistance as soon as possible for accidental ingestion.

5. Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, dry chemical powder, carbon dioxide, or appropriate foam for the immediate area.
Unsuitable Extinguishing Media: Avoid streams of water that may spread product.
Special Hazards: Fine dust in air can pose explosion hazard, but typical environments involve small quantities. Product decomposes at high temperature generating nitrogen oxides, carbon oxides, and sulfur oxides.
Personal Protective Equipment: Firefighters should wear full protective gear, including self-contained breathing apparatus.
Firefighting Procedures: Contain run-off. Avoid inhaling dangerous decomposition fumes.

6. Accidental Release Measures

Personal Precautions: Evacuate unprotected personnel. Wear dust mask, goggles, gloves, lab coat, and suitable protective clothing.
Environmental Precautions: Prevent large spills from entering drains, surface water, or groundwater.
Cleanup Methods: Sweep or vacuum without stirring up dust. Place collected material in a chemically compatible container for disposal.
Spill Reporting: Report large releases to appropriate local response authorities.
Further Actions: Clean area with plenty of water. Check for residue and restrict future access until decontamination is complete.

7. Handling and Storage

Handling: Avoid breathing dust. Minimize dust generation. Wash hands thoroughly after handling. Use in closed systems or in ventilated containment wherever practical.
Storage Conditions: Keep tightly closed in original packaging. Store in cool, dry, well-ventilated area away from heat and incompatible substances. Protect from moisture and direct sunlight.
Incompatible Materials: Strong oxidizing agents, acids, alkalis; avoid mixing with food or drink.
Other Recommendations: Ensure good labeling and separation from incompatible products. Store in secure area with controls for pharmaceuticals.

8. Exposure Controls and Personal Protection

Exposure Limits: No occupational exposure limit established; treat as nuisance dust at 10 mg/m³ (inhalable) and 3 mg/m³ (respirable) for particulates not otherwise specified.
Engineering Controls: Local exhaust ventilation, fume hoods, or laminar flow enclosures in pharma or lab settings.
Individual Protection:
- Respiratory Protection: NIOSH-approved respirator if dust present.
- Skin Protection: Impermeable gloves and lab coat.
- Eye Protection: Safety goggles with side shields.
- Hygiene Measures: Prohibit eating, drinking, or smoking near active pharmaceutical ingredients. Always wash hands and face before breaks or leaving the workspace.

9. Physical and Chemical Properties

Appearance: White to off-white crystalline or amorphous powder
Odor: Odorless
pH: 5.5-7.5 (1% solution)
Melting Point: Decomposes above 200°C
Boiling Point: Not applicable
Flash Point: Not flammable in bulk pharmaceutical form
Solubility: Soluble in water, very slightly soluble in ethanol and acetone
Bulk Density: 0.3–0.5 g/cm³
Vapor Pressure: Negligible
Partition Coefficient (log Kow): Not applicable, highly polar
Other Properties: Stable under normal lab and warehouse conditions.

10. Stability and Reactivity

Chemical Stability: Stable at room temperature when dry and sealed in the original container.
Reactivity: No known strong reactions with common substances in warehouse environments.
Conditions to Avoid: High humidity, direct sunlight, elevated temperatures.
Incompatibility: Reacts with strong oxidizers; hydrolysis occurs under acidic or alkaline conditions.
Decomposition Products: Produces toxic fumes of carbon oxides, nitrogen compounds, and sulfur oxides under combustion or severe heat.

11. Toxicological Information

Potential Health Effects: Paromomycin sulfate can cause irritation to skin, eyes, and respiratory tract. Allergic reactions possible in sensitized individuals. Systemic absorption may lead to kidney or hearing damage if mishandled.
Acute Toxicity: LD50 (oral, mouse): ~1500 mg/kg; inhalational toxicity not well established due to low volatility.
Chronic Effects: Long-term exposure may risk nephrotoxicity, ototoxicity, or hypersensitivity.
Routes of Exposure: Skin and eye contact, inhalation, accidental ingestion.
Symptoms of Overexposure: Nausea, dizziness, headache, vomiting, allergic responses.
Mutagenicity/Carcinogenicity: Not classified as carcinogenic. No conclusive long-term mutagenicity data.
Reproductive Toxicity: No known effect at occupational exposure levels.

12. Ecological Information

Ecotoxicity: Paromomycin can impact aquatic ecosystems. Bacteria in water and soil may respond with resistance development.
Aquatic Toxicity: Data limited. Risk of antibiotic persistence and bioaccumulation in aquatic environments remains a concern for water quality.
Terrestrial Toxicity: May impact soil microbiota, influencing nitrogen cycling.
Persistence and Degradability: Moderately persistent. Limited biodegradation under standard environmental conditions.
Mobility in Soil: Fairly mobile in aqueous solution.
Other Ecological Effects: Potential to contribute to antibiotic resistance genes in the environment.

13. Disposal Considerations

Product Disposal: Manage as pharmaceutical waste. Do not release into sewers, water bodies, or natural environments.
Container Disposal: Rinse and destroy packaging per approved pharmaceutical disposal protocols.
Preferred Treatment Options: Incinerate in licensed facility. Avoid landfill due to risk of antibiotic leaching.
Regulatory Controls: Follow local, regional, and national waste management legislation.
Special Instructions: Protect disposal handlers from exposure with gloves, particulate masks, and eye protection.

14. Transport Information

UN Number: Not classified as a hazardous material for transport under UN, IATA or IMDG codes.
Proper Shipping Name: Paromomycin sulfate
Packaging: Use high-integrity, sealed containers approved for pharmaceuticals. Special labeling for active ingredients recommended.
Transport Hazards: Not a flammable, explosive, nor radioactive product during transit.
Special Precautions: Avoid temperature extremes and exposure to moisture throughout shipment. Inform recipient of safe handling guidelines.

15. Regulatory Information

Classification: Regulated as a prescription pharmaceutical substance in many regions.
Occupational Safety: No statutory workplace exposure limit in most countries, but workplace controls recommended.
Environment: No specific environmental restrictions, but subject to general pollution prevention laws.
Other Regulations: Subject to pharmaceutical product, chemical inventory, and transportation controls under US FDA, EU EMEA, and similar authorities. FDA Drug Master File listing required for medical use.