MICROCRYSTALLINE CELLULOSE
SANCEL-101
| Parameters | IP | USP26 - NF21 |
| Appearance | Fine or granular, white or almost white powder, free flowing | Fine or granular, white or almost white powder, free flowing |
| Identification | ||
| A | Comply | Comply |
| B + C | Comply | Not Applicable |
| B Degree of Polymerization | Not Applicable | < 350 |
| pH | 5 - 7.5 | 5 - 7 |
| Starch and Dextrins | Absent | Not Applicable |
| Organic Impurities | Comply | Not Applicable |
| Organic Volatile Impurities | Not Applicable | Comply |
| Water Soluble Substances, %NMT | 0.2 | 0.24 |
| Ether Soluble Substances, % NMT | Not Applicable | 0.05 |
| Arsenic, PPM, NMT | 2 | Not Applicable |
| Heavy Metal, PPM, NMT | 10 | 10 |
| Residue on Ignition, % NMT | 0.2 | 0.05 |
| Loss on Drying, % NMT | 6 | 6 |
| Assay, % | 97 - 102 | Not Applicable |
| Conductivity, µS / cm,not exceed than water by | Not Applicable | 75 |
| Microbiology Analysis | ||
| Total Aerobic Microbial Count, CFU/g, NMT | 1000 | 1000 |
| Total Yeast and Mold Count, CFU/g, NMT | 100 | 100 |
| Pseudomonas aeruginosa,per 10 g | Absent | Absent |
| Escherichia coli, per 10 g | Absent | Absent |
| Staphylococcus aureus, per 10 g | Absent | Absent |
| Salmonella sp. per 10 g | Absent | Absent |
| Inhouse Specifications | ||
| Screen Analysis % Retention | ||
| 60 Mesh, NMT |
1
|
|
| 200 Mesh, NMT |
30
|
|
| Bulk Density, g/cc |
0.31 - 0.36
|
|
