Croscarmellose sodium from Indian supplier
Croscarmellose sodium from Indian supplier

Croscarmellose sodium from Indian supplier

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Product Overview

Description









Croscarmellose Sodium 


 


CAS No : 74811-65-7


Croscarmellose Sodium is internally cross linked sodium Carboxy Methyl Cellulose for use as a disintegrant in pharmaceutical formulations. The cross linking reduces water solubility while still allowing the material to swell and absorb many times its weight in water. As a result, it provides superior drug dissolution and disintegration characteristics, thus improving formula’s subsequent bioavailability.


Croscarmellose Sodium is developed to enhance drug dissolution. 


Croscarmellose sodium is a stable though hygroscopic material. It should be stored in a well-closed container in a cool & dry place.


 


CERTIFICATE OF ANALYSIS


 






































































































SR. NO



TESTS



RESULTS OF ANALYSIS



SPECIFICATION



1



Description



White powder



White or grayish white powder



2



Solubility



Complies



Practically insoluble in acetone, in anhydrous ethanol & in toluene



3



Identification :                    (A)



Complies



Absorbs the methylene blue and settles as a blue, fibrous mass.



 



                                                (B)



Complies



A red – purple color develops at the interface with 1-Napthol



 



                                                (C)



Complies



It gives reaction of sodium



4



pH



6.20



5.0 to 7.0



5



Degree of substitution



0.72



0.60 to 0.85



6



Water soluble content



8.68 %



NMT 10.0 %



7



Sodium chloride and sodium glycolate



0.37 %



NMT 0.5 %



8



Heavy metal



Complies



NMT 20 ppm



9



Loss on drying



5.81 %



NMT 10.0 %



10



Residue on ignition


(Sulphated Ash)



21.20 %



14 % to 28 %



11



Settling volume



19 ml



10 ml to 30 ml



12



Particle size (200 Mesh)



98.50 %



98% passing 200 Mesh



13



Microbial contamination


Aerobic count


Yeast & Mould count


E. coli



 


103.3cfu/g


40cfu/g


Absent



 


NMT 1000 cfu/g


NMT 100cfu/g


Absent



 


 


Application


Croscarmellose sodium is an internally cross-linked sodium carboxymethylcellulose for use as a superdisintegrant in pharmaceutical formulations. E468 is the E number of crosslinked sodium carboxymethyl cellulose, used in food as an emulsifier.



Croscarmellose-sodium.jpg


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