Microcrystalline Cellulose 101 BP
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Microcrystalline cellulose (MCC) is a term for refined wood pulp and is used as a texturizer, an anti-caking agent, a fat substitute, an emulsifier, an extender, and a bulking agent in food production. The most common form is used in vitamin supplements or tablets. Material meets BP- 2018 specifications
Typical Analysis |
|
Physical form |
Fine granular White or almost white odourless powder |
Colour |
White or almost white |
Chemical Test |
|
Solubility |
Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution. |
Solubility in ammoniacal solution of Copper teramine |
Dissolves completely leaving no residue |
Identification tests |
|
Test A |
The substance becomes violet blue |
Test B |
Polymerization not more than 350 |
pH of solution (2 % W/V solution in CO₂ free water) |
5.0 to 7.5 |
Starch & Dextrin |
No blue or brownish red colour is produced. |
Ether soluble substances |
Max.0.05% |
Water soluble substance |
Max.0.25% |
Heavy metals |
Maximum 10ppm |
Sulphated Ash |
Maximum 0.10% |
Loss on drying ( 105⁰ C for 3 hrs.) |
Max.7.0% |
Assay (dried basis) |
97.0%-102.0% |
Physical test |
|
Bulk density |
0.26 to 0.31 g/cm³ (untapped) |
Sieve analysis (% retention) |
60 mesh-NMT 1.0% |
Storage Conditions: To be stored on above ground on clean, dry & dust free godown
Packaging: 25 kgs.
Stability & Shelf Life:
Stable in sealed containers stored in shady , dry, and ventilated warehouse under normal conditions.Non- hygroscopic in nature and has long shelf life.
Usage and Applications of Microcrystalline Cellulose 101 BP:
- Microcrystalline Cellulose is a versatile product and used in pharmaceutical formulations as Excipient.
- MCC is also used in food industries as an anti-caking agent and a bulking agent.
- Microcrystalline Cellulose is derived from Wood pulp and the most common form is used in vitamin supplements or tablets.
- MCC 101- most suitable for wet granulation and direct compression.
- MCC 102- particle larger than 101 good flow and high compatibility , suitable for direct compression activity.
- MCC 103-same as grade 101 but with low moisture content for processing water sensitive actives.
- MCC 105-It has the finest particle size and may be used in direct compression of coarser , granular and crystalline materials.
- MCC 112-Same as grade 102 but with low moisture content for processing water sensitive actives.
- MCC 200-It has a large particle size which offers increase flow ability with minimum effect on compression characteristics.
- MCC 301-same as grade 101but with higher bulk density & improved flow properties.
- MCC 302-same as grade 102but with increased bulk density & increased flow properties. Suitable for high speed tableting and potential for smaller tablet.