Microcrystalline Cellulose
Microcrystalline Cellulose is known as Adsorbent, suspending agent, tablet and capsule diluent, tablet disintegrant.. This product is available in Arvin Kala’s diverse product portfolio.
Description
Microcrystalline cellulose is widely used in pharmaceuticals, primarily as a binder/diluent in oral tablet and capsule formulations where it is used in both wet-granulation and direct-compression processes. In addition to its use as a binder/diluent, microcrystalline cellulose also has some lubricant and disintegrant properties that make it useful in tableting.
Microcrystalline cellulose is a stable though hygroscopic material. The bulk material should be stored in a well-closed container in a cool, dry place.
Method of Manufacture
Microcrystalline cellulose is manufactured by controlled hydrolysis with dilute mineral acid solutions of a-cellulose, obtained as a pulp from fibrous plant materials. Following hydrolysis, the hydrocellulose is purified by filtration and the aqueous slurry is spray dried to form dry, porous particles of a broad size distribution.
Safety
Handling Precautions
Chemical-physical values
| Test Item | Unit | Specification |
|---|---|---|
|
DESCRIPTION |
|
A fine, or granular, white or alm ostwhite powder, Odourless (IP) White oralmost white, Fine or granular slightly hygroscopic powder.(BP/EP) Fine, white or almost white powder, It consists of free-flowing, nonfibrous particles.(USP) |
|
PH |
|
between 5.0 to 7.5 |
|
CONDUCTIVITY |
µS.cm-1 |
Does notexceed the conductivity of the water by more than 75 |
|
ASSAY |
%w/w |
ot less than 97.0R» and not more than L02.0% w/w of cellulose, calculated on dried basis. |
|
BULK DENSITY |
g/ml |
between 0.25 g/ml to 0.40 g/ml |
|
TAPPED DENSITY (IH) |
g/ml |
between 0.40 g/ml to 0.60 g/ml |
| Test Item | Unit | Specification |
|---|---|---|
|
ARSENIC |
ppm |
ot more than2 ppm |
|
LOSS ON DRYING |
% w/w |
Notmore than 6.0% w/w |
|
ESIDUE ON IGNITION |
% w/w |
ot more than 0.I% w/w |
|
ULPHATED ASH |
% w/w |
ot more that 0.2m w/w.(iP) Not more than 0.1% w/w.(BP/EP) |
|
MICROBIAL CONTAMINATION |
cfu/g |
Total ‘viable aerobic count: NMT 1000 Total yeast and mould count: NMT 100 Escherichia coli: Should be absent Pseudomonas aerugiosa: Should be absent Staphylococcus aurous: Should be absent |
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