High Purity Amorphous Silicon Dioxide with Controlled Particle Size for Use as Pharmaceutical Excipient and Flow Aid in Solid Dosage Formulations

🔷 Product Description

Pharmaceutical Grade Colloidal Silicon Dioxide is a high-purity amorphous silicon dioxide used as a multifunctional excipient in solid dosage formulation processes.

It is manufactured under strictly controlled conditions to ensure consistent physicochemical properties, high purity, and reliable performance in regulated pharmaceutical manufacturing environments.

This grade is available in compliance with major pharmacopeia standards including USP-NF and European Pharmacopoeia (Ph. Eur.) requirements, depending on customer specification.

2. USP / EP Standard Compliance Overview

✔ Regulatory Alignment

Note: Final compliance documentation (COA / regulatory statement) is provided per batch and customer requirement.

3. Key Specifications (Typical)

4. Functional Role in Pharmaceutical Manufacturing

Colloidal Silicon Dioxide is widely used as a processing excipient in solid dosage systems, supporting manufacturing efficiency and formulation consistency.

✔ Key Functional Roles:

• Flow improvement in powder blends
• Anti-caking performance in dry formulations
• Uniform mixing support in granulation processes
• Processing aid in capsule and tablet manufacturing
• Moisture adsorption control in powder systems

5. Applications (Regulated Industry Use)

• Tablet formulation systems
• Capsule powder blends
• Nutraceutical manufacturing (regulated-grade use)
• Dry powder processing
• Active ingredient blending support systems
• Pharmaceutical intermediate manufacturing processes

6. Quality Assurance & Documentation

To support regulated industry requirements, we provide full documentation packages:

• Certificate of Analysis (COA) per batch
• Material Safety Data Sheet (MSDS)
• Pharmacopeia compliance statement (USP / EP)
• Traceability records
• GMP manufacturing declaration (if required)

7. Packaging Options

• 10 kg pharmaceutical-grade fiber box/drum
• Double PE liner sealed packaging
• Customized packaging for OEM distribution
• Export-safe moisture-protected packing system

8. Why Global Buyers Choose Us

✔ Consistent pharmacopeia-aligned quality
✔ Stable batch-to-batch performance
✔ Strong regulatory documentation support
✔ Flexible USP / EP / JP grade supply options
✔ Reliable export supply chain for pharmaceutical industry

9. FAQ (SEO + Conversion Optimization)

Q1: Is your colloidal silicon dioxide USP compliant?

Yes, we offer material manufactured to meet USP-NF monograph requirements. COA is provided for each batch.

Q2: Can you supply EP grade silica excipient?

Yes, European Pharmacopoeia compliant grades are available upon request.

Q3: What is the main function in pharmaceutical formulation?

It is primarily used as a flow aid and processing excipient in solid dosage manufacturing.

Q4: Do you provide regulatory documents for audits?

Yes, full documentation including COA, MSDS, and compliance statements can be supplied.

10. Request a Quote

We support bulk supply for pharmaceutical manufacturers, distributors, and contract manufacturing organizations (CMOs).

👉 Contact us for:

• USP / EP grade pricing
• COA 
• Technical data sheets
• OEM/private label supply options