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Croscarmellose Sodium sodium croscarmellose 74811-65-7
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Product information
Croscarmellose sodium, or sodium CMC CAS:74811-65-7, is a cross-linked polymer of carboxymethylcellulose sodium. It appears as white, fibrous, free-flowing powder. Without a disintegrant, tablets may not dissolve appropriately and may effect the amount of active ingredient absorbed, thereby decreasing effectiveness. Caroxymethylcellulose sodium is generally regarded as safe when used in normal quantities.
Croscarmellose Sodium CAS: 74811-65-7 has a molecular formula of C8H9NaO7 and a molecular weight of 241.03200.
Application
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 bothdirect-compressionandwet-granulationprocesses.Whenused in wet granulations, the croscarmellose sodium should be added in both the wet and dry stages of the process (intra- and extragranularly) so that the wicking and swelling ability of the disintegrant is best utilized. Croscarmellose sodium at concentrations up to 5% w/w 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.
Specification
Items | Standard USP35/EP7.0/BP2013 | Result |
Characters | A White free flowing powder,odorless. | Complies |
Identification A;B;C | To meet requirement | Conforms |
PH | 5.0-7.0 | 6.6 |
Loss on Drying % | Not more than 10.0 | 2.6 |
Na-chloride&Na-glycolate % | Not more than 0.50 | 0.16 |
Heavy metals (ppm) | Not more than 10 | Conforms |
Degree of Substitution | 0.60-0.85 | 0.71 |
Water-soluble substances (%) | Not more than 10.0 | 8.1 |
Settling volume | 20-30 | 20.15 |
Retained 200 mesh(74Microns) | Not more than10.0 | 1.5 |
Residue on ignition | 14.0-28.0 | 15 |
Solubility | Complies | Conforms |
Total aerobic microbial count | Complies | Conforms |
Total molds and yeasts count | Complies | Conforms |
Escherichia coli | Absence | Conforms |
Conclusion:The product conforms to above test of [USP35/EP7.0/BP2013]. |
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