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Croscarmellose sodium
(Disintegrant, Dissolution aid)

DESCRIPTION :
Croscarmellose sodium is a cross linked polymer of carboxymethyl cellulose sodium. Cross linking makes it an insoluble, hydrophilic, highly absorbent material, resulting in excellent swelling properties and its unique fibrous nature gives it excellent water wicking capabilities. Croscarmellose sodium provides superior drug dissolution and disintegration characteristics, thus improving bioavailability of formulations.

 

APPLICATIONS :
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.

Concentrations of up to 5% w/w of Croscarmellose sodium may be used as a tablet disintegrant although normally 2% w/w is used in tablets prepared by direct compression and 3% w/w in tablets prepared by a wet-granulation process.


STABILITY AND STORAGE CONDITIONS :
Croscarmellose sodium is a stable though hygroscopic material.

Croscarmellose sodium should be stored in a well-closed container in a cool, dry, place.

 

Croscarmellose Sodium
Parameters USP 26-NF21
Identification
Methylene blue - Blue fibrous mass
1-Nepthol - Red-purple colour at interface
K-Antimonate-Sodium test positive
pH 5.0 - 7.0
Loss on Drying, NMT % 10
Sodium Chloride and Sodium Glycollate, sum NMT % 0.5
Heavy Metals, NMT % 0.001
Degree of Substitution 0.60 - 0.85
Content of Water Soluble Material, % 1.0 - 10.0
Settling Volume, ml 10.0 - 30.0
Organic Volatile Impurities  Meets the requirement

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