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SILSOL® 6035
SILSOL® 6035 is a high-purity silica powder containing an synthetic amorphous silican dioxide engineered to bring together advanced silica technologies with challenging active pharmaceutical ingredients (APIs). Formulated with a fine sized, high pore volume of 0.8-1.0 ml/g and a large internal surface area, SILSOL® 6035 is suitable for a range of applications in pharmaceuticals and nutraceuticals.
SILSOL® 6035 silica active ingredient delivery technology combines Grace’s extensive expertise in mesoporous silica gel, novel application methods, and patented technologies to provide enhanced developement of solubility enhancing solid dispersions and challenging active pharmaceutical ingredients (APIs). It is a free flowing slica powder that enables consisent and uniformed processing and dosing in pharmaceutical and nutraceutical formulations. With an average particle size of 20─71 µm and a large surface area, this material offers excellent bioavailability through the delivery of amorphous drug forms and enhanced stability properties, preventing the recrystallization of solud dispersions.
Specifications
Appearance: Powder Color: White pH (USP, 5 % aqueous suspension): 4.0─8.0 Loss on drying (USP, 145°C, 4 h): 5.0% max. Loss on ignition (USP, 1000°F, 1 h): 8.5% max. Average particle size malvern® Mastersizer®: 20─71 µm Iron Oxide (Fe₂O₃) dry basis: 0.03% max. Sodium oxide (Na₂O) dry basis 0.15% max Sulfate (SO₄): 0.5% max SiO₂ content (dry basis): 99.0% min Pore Volume (N2): 0.8-1.0 ml/g Chlorides (Cl) dry basis, USP: 0.1 % max. Calcium Oxide (CaO): 0.14 % max. Arsenic (As): 0.5 mg/kg max. Cadmium (Cd): 0.5 mg/kg max. Mercury (Hg): 0.1 mg/kg max. Lead (Pb): 1.0 mg/kg max. Total aerobic plate count: 1000 cfu/g Yeast and Mold 100 cfu/g Pseudomonas Aeruginosa <10 cfu/g Salmonella: Negative E-coli: Negative Staphylococcus Aureus <10 cfu/g Bulk Density: 420 g/l Average Particle Size 37µm Silica (SiO2): 99.8%
Primary Chemistry: Amorphous silicon dioxide
Features & Benefits
High purity synthetic amorphous silicon dioxide Pharmaceutical excipient High pore volume Large internal surface area Excellent compatibility Enhanced bioavailability Excellent stability Pharmacopoeia acceptance Scalability FDA complience
Problems Solved
Enhanced bioavailability Improved stability
Applications
APIs Pharmacuetical products Nutraceutical extracts Film coatings Sublingual and effervescent tablets Liquisolid pharmaceuticals
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