Powdered Cellulose Specifications
Test | JP 2001 | PhEur 2005 | USPNF 23 |
---|---|---|---|
Identification | ✅ | ✅ | ✅ |
pH (10% w/w) | 5.0–7.5 | 5.0–7.5 | 5.0–7.5 |
Loss on Drying | ≤6.0% | ≤6.5% | ≤6.0% |
Residue on Ignition | ≤0.3% | ≤0.3% | ≤0.3% |
Microbial Limits | Aerobic ≤10³ CFU/g, Fungi & Yeast ≤10² CFU/g | ||
Impurities | Ether ≤0.15%, Water ≤1.5%, Heavy Metals ≤10 ppm |
Applications in Pharmaceutical Formulation
Powdered cellulose is used as a tablet diluent, capsule filler, and suspending agent. It provides bulk, aids compression, and reduces sedimentation in soft gelatin capsules, aqueous suspensions, and suppositories. Low-crystallinity variants improve direct compression.
Comments
Powdered cellulose is listed in the Food Chemicals Codex (FCC) and has the EINECS number 232-674-9.