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Croscarmellose Sodium BP / USP

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Croscarmellose sodium is a carboxymethylcellulose (CMC) that is widely used as an additive in pharmaceutical and non-pharmaceutical industry; in particular, it is used in oral pharmaceutical formulations as a disintegrant for capsules, tablets and granules.

Appearance White or grayish white powder
Solubility Practically insoluble in acetone, in anhydrous ethanol and in toluene
Identification  
Test - A Settles as a blue fibrous mass
Test - B A reddish-violet colour develops at the interface
Test - C Gives reaction of sodium salt.

A portion of mixture of croscarmellose sodium with water, prepared as directed in identification B, imparts and intense yellow color to a non luminous flame.

   
pH of Solution (1.0% w/v CO2 free water) Between 5.0 to 7.0
Sodium Chloride & Sodium Glycolate (Calculated on dried basis) Maximum 0.5% w/w
Water Soluble Substances Maximum 10.0%
Heavy metals Maximum 20 ppm (BP) / 10 ppm (USP)
Loss on drying (at 105⁰ C for 6 hours) Maximum 10.0%
Sulphate Ash (As per BP)

Residue on Ignition (As per USP)

Between 14.0 to 28.0%
Settling Volume Between 10.0 to 30.0 ml.
Degree of Substitution (Calculates on dried basis) Between 0.60 to 0.85
Residual Solvents (Methanol) Maximum 3000 ppm
Particle Size Not less than 95% passing through 100 Mesh

Not less than 65% passing through 150 Mesh


Shelf life: 3 years
Storage: Keep the product tightly closed and in dry condition


 

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