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Product Overview

It is a high purity, hydrophilic fumed silica used as an excipient in pharmaceutical, cosmetic and food formulations. In pharmaceutical applications, AEROSIL functions primarily as a glidant, anti-caking agent, thickener, and suspending agent. Its versatility, safety profile, and effectiveness make it a valuable component in a wide range of pharmaceutical and industrial formulations.

Product Type: Pharmaceutical Excipient

Chemical Name Colloidal Silicon Dioxide (Fumed Silica)
Chemical Formula SiO₂
CAS Number 7631-86-9
Molecular Weight ~60.08 g/mol
Application Role Glidant, anti-caking agent, thickening agent, suspending agent in pharmaceutical and cosmetic formulations
Regulatory Compliance IP / BP / USP / EP
Manufacturing Suitability Suitable for solid dosage forms (tablets, capsules), semi-solids (creams, gels), and liquid suspensions; compatible with direct compression and wet granulation
Storage Conditions Store in a tightly closed container in a cool, dry, well-ventilated area; protect from moisture and static discharge
Certifications GMP compliant, ISO 9001 / ISO 14001 certified production, DMF available
Availability Widely available through authorized distributors worldwide in multiple packaging sizes
HS Code 2811.22.00

Excipient Technical Profile

Appearance White, fluffy, odorless, extremely light powder
Bulk Density ~30–60 g/L
Solubility Insoluble in water and most organic solvents; dispersible in water, glycols, and other liquids forming stable colloidal suspensions or gels when properly mixed
pH (4% aqueous dispersion) 3.6 – 4.5

Typical Applications

Key Benefits

Enhanced powder flowability
Regulatory and global compliance
Anti-caking properties
Versatility
High purity and inertness
Enhances product stability

Safety Info

⚠️Safety Information: AEROSIL 200/400

Toxicology

  • AEROSIL (colloidal silicon dioxide) is considered non-toxic and non-irritant when used in typical excipient amounts
  • Recognized as Generally Recognized As Safe (GRAS) by the U.S. FDA for use in food and pharmaceuticals
  • No evidence of mutagenicity, carcinogenicity, or reproductive toxicity at normal exposure levels

Handling Precautions

  • Fine powder can become airborne easily and pose an inhalation risk
  • Prolonged inhalation of respirable silica dust may cause respiratory irritation
  • Use appropriate PPE such as masks, goggles, and gloves when handling large quantities
  • Work in well-ventilated areas or use local exhaust ventilation

Storage and Disposal

  • Store in a cool, dry place away from moisture to prevent agglomeration
  • Avoid dust generation and static discharge
  • Dispose of according to local regulations; considered inert and non-hazardous waste

First Aid Measures

  • Inhalation: Move to fresh air and seek medical attention if symptoms persist
  • Skin contact: Wash with soap and water
  • Eye contact: Rinse cautiously with water for several minutes
  • Ingestion: Low toxicity; rinse mouth and seek medical advice if discomfort occurs

Why Choose Salius Pharma?

  • GMP-Compliant Quality: Stringent QC to ensure consistent, premium-grade excipients.
  • Regulatory Support: Comprehensive documentation available.
  • Reliable Supply: Global distribution with timely delivery.
  • Technical Expertise: Dedicated formulation support and customer service.
  • Customized Solutions: Flexible packaging and product grades tailored to your needs.
Documents We Provide

FAQs

Yes, but caution is required as AEROSIL can adsorb moisture due to its high surface area. Moisture-protective packaging may be necessary.

At typical glidant concentrations it generally does not affect disintegration, though higher levels may retard it.

It disperses well in water-based systems but has limited compatibility with non-polar solvents unless surface-modified grades are used.

Yes. COA, MSDS, DMF, Stability Data, COS, Impurity Profile, BA/BE Studies, and WHO-GMP/ISO certificates are available upon request.

Indirectly, by improving powder flow and uniformity, it supports consistent dosing but does not directly enhance solubility or absorption.

You can contact export@saliuspharma.com or submit an inquiry through the website Visit On www.saliusapi.com Responses are provided within 24–48 hours.

What You Receive with Every Order

At Salius Pharma, we deliver more than just an excipient — we deliver confidence, compliance, and quality. Every shipment is thoughtfully prepared to meet international regulatory standards and your exact specifications.

What’s Included:

✔ Premium Product:
✔ Custom Packaging Options:

Place an Order or Request a Quote from Salius Pharma

Looking to source Aerosil 200/400 or other high-quality pharmaceutical products?
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Whether you need Active Pharmaceutical Ingredients (APIs), excipients, or regulatory support, our team is ready to provide reliable, compliant, and cost-effective solutions tailored to your market needs.

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Any patented products are excluded from our offerings in regions where such patents are currently in force.

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