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AEROSIL® colloidal silicon dioxide regulatory information

AEROSIL® fumed silica is a high purity synthetic amorphous silica, with a silicon dioxide content of over 99.8 %. Over the last 50 years, many studies have been undertaken and all have shown that, unlike crystalline silica, the amorphous structure of colloidal silicon dioxide does not induce pulmonary fibrosis. AEROSIL® colloidal silicon dioxide has been safely used as a pharmaceutical excipient for decades.

All AEROSIL® Pharma grades are manufactured according to IPEC GMP guidelines for bulk pharmaceutical excipients. Every lot is tested and certified according to compendial methods.

 

Compendial compliance of AEROSIL® products

Product

USP/NF

Ph. EUR.

JP

DMF*

AEROSIL® 200 Pharma

"Colloidal silicon dioxide"

"Silica, colloidal anhydrous"

"Light anhydrous silicic acid"

1115

AEROSIL® 300 Pharma

"Colloidal silicon dioxide"

"Silica, colloidal anhydrous"

"Light anhydrous silicic acid"

1115

AEROSIL® 300 Pharma

"Colloidal silicon dioxide"

"Silica, colloidal anhydrous"

**

1115

AEROSIL® R 972 Pharma

"Hydrophobic colloidal silica"

"Silica, hydrophobic colloidal"

No monograph

1115

* US Food and Drug Administration (FDA) Drug Master File Type IV (excipient) 

** Granulated AEROPERL® 300 Pharma does not fulfill the JP "Volume Test" due to its high bulk density