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Xysil 200 Pharma Fumed silica 200P
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Xysil 200 Pharma Fumed silica 200P is a high-purity, pharmaceutical-grade fumed silica produced via flame hydrolysis of silicon tetrachloride. This ultra-fine, amorphous white powder features a very high surface area and low bulk density, designed specifically to meet stringent pharma standards. It functions as a flow agent, anti-caking agent, and thickener in pharmaceutical formulations, enhancing powder flow, stability, and product consistency.
Description
Xysil 200 Pharma Fumed silica 200P
Primary Uses
Pharmaceutical Industry
- Flow Aid: Improves powder flowability in tablet and capsule manufacturing, reducing clogging and enhancing process efficiency.
- Anti-Caking Agent: Prevents clumping and moisture absorption in powdered drug formulations and excipients.
- Thickening Agent: Used in suspensions and topical formulations to improve viscosity and stability.
Cosmetics & Personal Care
- Rheology Modifier: Enhances texture and stability of creams, lotions, and powders in personal care products.
Secondary Uses
Food Industry
- Anti-Caking Agent: Employed in powdered food supplements and nutraceuticals (subject to regulatory approvals).
Chemical Industry
- Reinforcing Filler: Occasionally used in specialty silicone rubbers and adhesives requiring pharmaceutical-grade additives.
KEY PRODUCT FEATURES
Basic Identification Attributes
- Chemical Name (IUPAC): Silicon dioxide, amorphous
- Common/Trade Name: Xysil 200 Pharma, Fumed Silica 200P
- CAS Number: 112945-52-5
- HS Code: 2811.19.00
- Synonyms: Pyrogenic silica, pharmaceutical-grade fumed silica
Physical & Chemical Properties
- Physical State: Powder
- Color & Odor: White; odorless
- Surface Area: Approx. 200 m²/g
- Particle Size: Average primary particle size ~12 nm
- Bulk Density: Approx. 50 kg/m³ (loose bulk density)
- Solubility: Insoluble in water and organic solvents
- pH (in 4% suspension): 3.7 – 4.5
Safety & Hazard Attributes
- GHS Classification: May cause respiratory irritation (dust)
- Toxicity: Low toxicity; safe for pharmaceutical use when handled properly
- Exposure Limits: Adhere to occupational exposure limits for respirable silica dust
Storage & Handling Attributes
- Storage Conditions: Store in a cool, dry, well-ventilated area away from moisture and incompatible substances
- Container Type: Multi-layer kraft paper bags with polyethylene liner, pharmaceutical-grade packaging
- Shelf Life: Indefinite under proper storage conditions
- Handling Precautions: Minimize dust generation; use appropriate PPE including respiratory protection
Regulatory & Compliance Attributes
- Complies with pharmacopeial standards (e.g., USP, EP) for pharmaceutical applications
- Manufactured under Good Manufacturing Practices (GMP) to ensure purity and consistency
- Meets FDA and EMA requirements for pharmaceutical excipients
- Complies with REACH, TSCA, OSHA, and other relevant safety regulations
- Meets ISO 9001 quality management standards
- Suitable for use in pharmaceutical, cosmetic, and food applications (subject to regulatory approvals)
Environmental & Health Impact
- Biodegradability: Not biodegradable (inorganic)
- Ecotoxicity: Low environmental impact, inert material
- Bioaccumulation: Not applicable
SAFETY HANDLING PRECAUTIONS
Safety Handling Precautions
- PPE Required: Respiratory protection, gloves, and eye protection recommended
- Handling Guidelines: Use local exhaust ventilation; avoid airborne dust
- Storage Measures: Keep containers sealed and dry
First Aid Measures
- Inhalation: Move affected person to fresh air; seek medical attention if irritation persists
- Skin Contact: Wash skin with soap and water
- Eye Contact: Flush eyes with water for at least 15 minutes; seek medical advice if irritation continues
- Ingestion: Rinse mouth; consult physician if adverse effects occur
Firefighting Measures
- Fire Hazards: Non-flammable
- Extinguishing Media: Use extinguishing media appropriate for surrounding fire
- Hazardous Combustion Products: None known
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