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Simethicone USP
Simethicone USP is a silicon-based surfactant used primarily as an anti-foaming and anti-gas agent in pharmaceutical and food industries. It works by reducing the surface tension of gas bubbles, causing them to coalesce and be expelled more easily from the digestive tract. This non-toxic, inert compound is widely used in formulations to relieve bloating, discomfort, and flatulence caused by excess gas. The “USP 28” grade signifies compliance with the United States Pharmacopeia standards, ensuring high purity and quality for medical and food applications.
Simethicone USP
Primary Uses
- Pharmaceutical Industry
- Used as an active ingredient in anti-flatulent and digestive relief products to reduce bloating and gas discomfort.
- Incorporated in oral suspensions, tablets, and capsules to improve patient comfort by alleviating gastrointestinal gas.
- Acts as an anti-foaming agent in liquid formulations to enhance manufacturing efficiency and product stability.
- Food Industry
- Employed as a food additive to prevent foaming in food processing and packaging, especially in beverages and sauces.
- Used in processing oils and fats to control foam formation during manufacturing.
- Cosmetics and Personal Care
- Included in topical creams and lotions as an anti-foaming agent to improve texture and application.
- Used in shampoos and bath products to control foam consistency.
- Industrial Applications
- Used in manufacturing processes requiring foam suppression in lubricants, paints, and coatings.
Secondary Uses
- Laboratory and Analytical Uses
- Utilized in chemical laboratories to control foam during reactions and liquid handling.
- Veterinary Medicine
- Used in veterinary formulations to relieve gas-related digestive discomfort in animals.
1. Basic Identification Attributes
- Chemical Name (IUPAC): Polydimethylsiloxane and silica gel
- Common/Trade Name: Simethicone 100% USP 28
- CAS Number: 8050-81-5
- HS Code: 3819.00
- Synonyms: Dimethicone copolyol, Silicone anti-foaming agent
2. Physical & Chemical Properties
- Physical State: Viscous liquid or gel
- Color & Odor: Clear to slightly opaque; odorless
- Solubility: Insoluble in water; soluble in organic solvents
- Density: Approx. 1.05 g/cm³
- Stability: Chemically stable under normal storage conditions
3. Safety & Hazard Attributes
- GHS Classification: Generally regarded as safe; low toxicity
- Toxicity: Non-toxic and non-irritant under recommended use conditions
- Exposure Limits: No specific occupational limits; follow general safety practices
4. Storage & Handling Attributes
- Storage Conditions: Store in tightly closed containers in a cool, dry place away from direct sunlight
- Container Type: Plastic or metal drums, bottles, or bulk containers
- Shelf Life: Typically 24 months if stored properly
- Handling Precautions: Use gloves and avoid inhalation of aerosols or mists
5. Regulatory & Compliance Attributes
- Complies with USP standards for pharmaceutical and food-grade products
- Approved by FDA and other regulatory agencies for use in food and drugs
- Manufactured in GMP-certified facilities
6. Environmental & Health Impact
- Biodegradability: Poorly biodegradable but considered environmentally safe at low concentrations
- Ecotoxicity: Low toxicity to aquatic organisms
- Bioaccumulation: Not significant
Safety Handling Precautions
- PPE Required: Gloves recommended; goggles if splashing is possible
- Handling Guidelines: Avoid inhaling aerosols; use in well-ventilated areas
- Storage Measures: Keep containers tightly closed and stored in a dry environment
First Aid Measures
- Inhalation: Move to fresh air; seek medical attention if respiratory irritation occurs
- Skin Contact: Wash with soap and water; seek medical advice if irritation develops
- Eye Contact: Rinse thoroughly with water for 15 minutes; get medical help if irritation persists
- Ingestion: Rinse mouth; seek medical help if discomfort occurs
Firefighting Measures
- Fire Hazards: Non-flammable
- Extinguishing Media: Water spray, foam, dry chemical, or CO₂ for surrounding fires
- Special Precautions: Use protective equipment to avoid exposure to fumes from other materials
- Hazardous Combustion Products: May produce silicon oxides and other fumes under combustion
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