Xysil 200 Pharma Fumed silica 200P

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