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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.
- Manufacturer: Grace
- Product Line: SILSOL® Silica
- Product: SILSOL® Silica Excipients
- Industries: Pharmaceuticals
- Authorized Countries: Canada | United States
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Overview
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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