FR-CELL S is composed microcrystalline cellulose (MCC) and colloidel sillicon dioxide (CSD). Being a multifunctional excipient, it has excellent compaction ability and better binding properties than MCC.
| Grade | Sieve Analysis (% Retention) | Bulk Density (g/ml) | Moisture (%) | |
|---|---|---|---|---|
| 60 mesh | 200 mesh | |||
| FR-Cell S SMCC 50 | ≤ 1.0% | ≤ 30.0% | 0.25 - 0.37 | NMT 7.0 |
| FR-Cell S SMCC 90 | ≤ 8.0% | ≥ 45.0% | 0.25 - 0.37 | NMT 7.0 |
| FR-Cell S SMCC HD 90 | ≤ 8.0% | ≥ 45.0% | 0.38 - 0.50 | NMT 7.0 |
| Tests | Acceptance Criteria |
|---|---|
| Identification A | IR Scan |
| Identification B (lodinated zinc chloride solution) | Violet-blue color |
| Identification C | Deep yellow color |
| Silica dispersion uniformity test | NMT 0.02 |
| Residue on Ignition | 1.8% -2.2% |
| Conductivity | NMT 75 µS/cm |
| pH | 5.0 - 7.5 |
| Loss on Drying | NMT 7.0% |
| Degree of Polymerization | NMT 350 |
| Water-soluble substances | NMT 0.25% |
| Ether-soluble substances | NMT 0.05% |
| Total aerobic microbial count | NMT 1000 cfu/g |
| Total combined molds and yeasts count | NMT 100 cfu/g |
NMT : Not more than
cfu : Colony-forming unit
Optimal compaction, proper flow.
Balanced flow and compactibility.
Higher bulk density and shortest disintegration time.