Microcrystalline Cellulose 102 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.

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	0.28 to 0.34 g/cm³ (untapped)
Sieve analysis (% retention)	60 mesh-NMT 8.0%
Microbial test
Total Aerobic Microbial Count	Not more than 1000 CFU/g
Total yeasts and mould count	Not more than 100 CFU/g
Escherichia coli & Salmonella	Should be absent
Staphylocaccus aureus	Should be absent
Pseudomonus aeruginosa	Should be absent

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 102 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.