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SYLOID® 63 FP is a white, free-flowing silica powder from GRACE designed with a low pore volume of 0.4 ml/g and a large internal surface area. It is recommended as a free-flow and tableting additive for humidity-sensitive pharmaceutical formulations.
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SYLOID® 63 FP is a unique mesoporous silica excipient consisting of a chemically prepared, synthetic amorphous silicon dioxide (CAS no. 7631-86-9). Its highly defined pore structure has a low pore volume of 0.4 ml/g with a density of 0.41 g/cc, allowing for excellent adsorption, particle size distribution, and internal surface area and creating less dust for easier GMP compliance and more compact storage. It also helps to minimize the number of excipients required in pharmaceutical formulations and improves the effectiveness of products. SYLOID® 63 FP is especially recommended as a free-flow and tableting additive, providing exceptional compatibility with active ingredients. Its excellent moisture protection properties ensure silicas control moisture transfer in humidity-sensitive applications, preventing reactions that negatively impact drugs or decrease shelf life.
Appearance: Powder
Color: White
Loss on ignition (1832°F): 8.5% max.
Loss on drying (145°C): 4.0% max.
SiO₂ content (dry basis): 99.0% min
Sulfate (SO₄): 0.5% max
pH (5% slurry): 4.0─6.0
Oil adsorption: 80 g/100g
Pore volume (H₂O): 0.4 ml/g
Apparent Bulk Density: 0.29 g/cc
Compacted Bulk Density: 0.41 g/cc
Chlorides (Cl): ≤0.1 wt. % max.
Mercury (Hg): ≤0.1 ppm
Iron (Fe₂O₃): 200 ppm max.
Aluminum oxide (Al₂O₃): ≤0.2 wt. % max.
Sodium oxide (Na₂O) ≤0.2 wt. %
Calcium Oxide (CaO): ≤0.14 wt. % max.
Arsenic (As): ≤0.5 ppm
Lead (Pb): ≤0.5 ppm
Cadmium (Cd): ≤0.5 ppm
Sodium sulfate (Na₂SO₄): ≤1.5 wt. %
Heavy metals: ≤20 ppm
Total aerobic plate count: ≤500 cfu/g
CAS no. 7631-86-9
Primary Chemistry: Amorphous silicon dioxide
Amorphous silicon dioxide
Multifunctional excipient
Free-flow additive
High purity
Improve manufacturing efficiency, dissolution, therapeutic effectiveness, and stability
Moisture protection
Reduces electrostatic charging
Improves flow properties
Moisture-assisted dry granulation
Excellent compatibility with activity
Oil absorption properties in lipid-based technologies
Prevents valve blockage in direct compression
Highly defined pore structures
Excellent porosity and particle size distribution
Enhanced moisture protection
Anti-sticking and anti-tacking
Absorbs up to 1.5 ml of liquid per gram
Matting agent
Anti-caking
Prevents clumping
Viscosity control
Valve blockage in direct compression applications
APIs
Pharmaceutical products
Nutraceutical extracts
Film coatings
Sublingual and effervescent tablets
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