Neusilin® UFL2

Product Specification
Neusilin® - The Specialty Excipient Chemical Formula & General Name
A synthetic magnesium aluminometasilicate (MAS) Al2O3·MgO·1.7SiO2·xH2O
with exceptional excipient properties for improving Magnesium Aluminometasilicate (JPC02, USP/NF21)
actives delivery and quality of pharmaceutical
preparations. Although chemically the same as Key Applications
traditional crystalline MAS, Neusilin® is both Improves powder flowability
structurally and functionally very different. Fuji Anti-caking agent for hygroscopic powders
Chemical’s proprietary manufacturing process and Oil adsorption of poorly water soluble actives
Stabilization of deliquescent drugs
spray-drying produces a totally unconventional Excipient for direct compression
product. Improves tablet and powder capsule quality

General Properties Quantity Needed

Appearance white powder Grade UFL2

Crystal form amorphous 1-10%
Tablet - binder, Disintegrator, Increase Hardness
True specific gravity 2.2
Adsorption Agent 2-10%
Solubility practically insoluble in water and in ethanol.
Increase Flowability 0.5-5%
Compositions* Al2O3 29.1-35.5
(Dried at 110˚) (%) Mg O 11.4-14.0 Stabilization of Deliquescent Drugs 5-15%
SiO2 29.2-35.6
Excipient 30-90%

Solidification of Liquid Pharmaceutical Preparations 30-50%

Typical Specifications
Degree of whiteness: More than 95

Loss on drying 110ºC/7Hrs: Less than 7%

Apparent specific volume

Loose: 9.0-18.0 mL/g
Tapped: 6.0-10.0 mL/g

Specific surface area: 300 m2/g

Residue on 330 mesh: Less than 0.5%

Angle of repose: 45°C

Oil adsorbing capacity: 2.7 - 3.4 mL/g

Water adsorbing capacity: 2.4 - 3.1 mL/g

Acid consuming capacity: More than 200

pH 4% slurry: 6.0 - 8.0

Packaging: 5 kg double-lined craft bags.

Storage: Store at room temperature and away from high humidity.

Shelf-life: 3 years from date of manufacture stored in

recommended conditions.

Organic Volatile Impurities Tested.

Neusilin® specifications conforms to JPC2002 and USP/NF.
US DMF Type IV Excipient Filed INCI: Magnesium aluminosilicate

55 Yokohoonji, Kamiichi-Machi, Nakaniikawa-gun, Toyama 930-0397, Japan. Tel: +81-76-472-5549 Fax: +81-76-472-5417 www.fujichemical.co.jp Email: info@fujichemical.co.jp
Information found is presented in good faith with no guarantee or obligation as to accuracy and no assumption of liability. The information herein does not imply a performance
warranty. Purchasers should decide the suitability of the product with respect to their desired application and purpose.

MAS/IBD/V1 Rev. 05.12.05