| MICROCRYSTALLINE CELLULOSE (MCC) |
| Specifications as per USP XXIII/NF 18 |
PROPERTIES |
|
| Appearance | A fine odourless, crystalline powder which consists of free-flowing , non-fibrous particles |
| Identification as per NF 18, USP 23 Test A;B;C | Passes as per NF and USP |
| Solubility | Insoluble in water and dilute acids, slightly soluble in 20% sodium hydroxide with slight swelling |
| pH of aqueous extract | 5.0 – 7.0 |
| Loss on drying | 7.0% w/w max. |
| Water soluble substances | 0.24% w/w |
| Starch | Absent |
| Residue on ignition | 0.050% w/w |
| Organic volatile impurities | Nil |
| Conductivity | Passes as per test |
| Bulk density | 0.28 – 0.33 |
| Ether solubles | 0.05% |
MICROBIAL LIMITS |
|
| Total aerobic microbial count | Not more than 1000 per g. |
| Total combined molds yeast count | Not more than 100 per g. |
| Staphylococcus Aureous | Absent |
| Pseudomonas | Absent |
| All grades are spray dried. | |