Silica for Pharmaceutical Excipients
FINE-SIL520 series silica for food additives has been tested to meet the requirements of China HG/2791-1996 standard and FCC (U.S.) Food Chemicals Codex, and a product hygiene license has been issued. Ultra-low treatment is specially applied to heavy metals (Pb, Sb, etc.) and bacteria. It is mainly used as food anti-caking agent, thickener, coagulant, carrier for flavors, fragrances and active ingredients, quality improver, oil adsorbent, pharmaceutical excipients and clarifying filter aid.
FINE-SILIL520 Pharmaceutical Grade Silica (Micronized Silicon Dioxide) is a new type of excipient used in pharmaceutical preparations. It is a white powder with high purity and excellent fluidity. It is an excellent flow promoter in tablet production, which can greatly improve granule flowability, increase bulk density, enhance tablet hardness and shorten disintegration time, thereby improving drug dissolution rate. Since most extracts of Chinese patent medicines have the characteristics of moisture and hygroscopicity, micronized silicon dioxide, with its properties of absorbing water and promoting flow, is also very suitable for use in capsules and other pharmaceuticals.
| Item | Index (%) | |
|---|---|---|
| HG/2791-1996 | FINE-SIL520 | |
| SiO₂ (Dry Basis) % ≥ | 96 | 98 |
| Loss on Drying (105℃) % ≤ | 5 | 4.7 |
| Loss on Ignition (950℃) % ≤ | 8.5 | 5-6 |
| Heavy Metal (as Pb) Content ≤ | 0.003 | 0.003 |
| Lead (Pb) Content ≤ | 0.001 | 0.00006 |
| Arsenic (As) Content ≤ | 0.0003 | 0.000001 |
| Soluble Salt (as Na₂SO₄) Content % ≤ | 4 | 1.5 |