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Croscarmellose Sodium

Excipients
CCS Croscarmellose Sodium
Grades
CAS NO 74811-65-7
HS Code 29420090
Molecular Formula C2H4O3·xNa·x
Applications A cellulose-based superdisintegrant, providing excellent results in
tablet disintegration. Used at a level of 1 - 4 % only, it is one of the
most efficient superdisintegrants in pharmaceutical
technology. It can be used in all tableting processes, good for
medium soluble actives.
Packing Type 25 Kgs Corrugated boxes / Fiber Drum
STANDARDS SPECIFICATION REFERENCE
Particle size distribution (By Malvern)
D(v,0.1) NMT 25 µm In house method
D(v,0.5) 25-55 µm
D(v,0.9) NLT 60 µm
 
PHARMACOPOEIAL TEST ITEMS SPECIFICATION REFERENCE
Loss on drying NMT 10.0% Ph. Eur., NF, JP
pH 5.0 - 7.0 Ph. Eur., NF, JP
Residue on Ethanol max. 0.5% In house method
The raw materials, manufacturing process and product do not contain any of the solvents listed in Residual Solvents (Ph. Eur. <5.4>, USP<467>) except for ethanol limited to < 0.5%

Croscarmellose sodium is an internally cross-linked sodium carboxymethylcellulose for use as a superdisintegrant in pharmaceutical formulations.[1]


Croscarmellose sodium, or sodium CMC, is a cross-linked polymer of carboxymethylcellulose sodium. It appears as white, fibrous, free-flowing powder.

Disintegrants facilitate the breakup of a tablet in the intestinal tract after oral administration. Cross-linking allows enhanced bioavailability of the drug through superior drug dissolution. Without a disintegrant, tablets may not dissolve appropriately and may effect the amount of active ingredient absorbed, thereby decreasing effectiveness


Croscarmellose sodium is used in oral pharmaceutical formulations as a disintegrant for Capsules, Tablets and Granules. In tablet formulations, Croscarmellose sodium may be used in both direct-compression and wet-granulation processes. When used in wet granulations the Croscarmellose sodium is best added in both the wet and dry stages of the process (intra- and extra granularly) so that the wicking and swelling ability of the disintegrant is best utilized.

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