Croscarmellose Sodium
Croscarmellose Sodium
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. It is an odourless, relatively free flowing, white powder.
Croscarmellose Sodium
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. It is an odourless, relatively free flowing, white powder.
Application in Pharmaceuticals
In formulations as a disintegrant for capsules tablets and granules
In wet granulations, CICSEL can be added in both the wet and dry stages of the process so that the wicking and swelling ability of the disintegrant is best utilized.
Concentrations of normally 2% w/w is used in tablets in direct compression and 3% w/w in tablets inwet-granulation process.
Suitable for products where the use of starch products is contraindicated.
Works by attracting water into the tablet pores (wicking) followed by swelling.
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Croscarmellose Sodium IP/BP/USP
| Test | Specification |
|---|---|
| Description/ Appearance | 1. A White or greyish-white powder as IP. 2. White or greyish-white hygroscopic powder as BP. 3. White, free-flowing powder as USP |
| Solubility | 1. Partially soluble in water; insoluble in alcohol, in ether, and in other organic solvents as IP/USP. 2. Practically insoluble in acetone, in anhydrous ethanol and in toluene as BP |
| Identification Test – A | 1. Settles as a blue, fibrous mass as IP/BP. 2. Croscarmellose Sodium absorbs the methylene blue and settles as a blue, fibrous mass. |
| Identification Test B | A reddish-violet color develops at the interface as IP/BP/USP |
| Identification Test – C | A dense white precipitate is formed as IP/BP/USP. |
| pH | Between 5.0 – 7.0 as IP/BP/USP |
| Sodium chloride & sodium glycolate | NMT 0.5% as IP/BP/USP |
| Water soluble substances | NMT 10.0% as IP/BP/USP |
| Loss on drying | NMT 10.0% as IP/BP/USP |
| Sulphated ash/ Residue on Ignition | 14.0% to 28.0% as IP/BP/USP |
| Loss on drying | NMT 15% as IP/BP, NMT 14% as USP |
| Sulphated ash/ Residue on Ignition | NMT 0.6% as IP/BP, NMT 0.5% as USP |
| Settling volume | 10.0 ml– 30.0 ml as IP/BP/USP |
| Degree of substitution | 0.60 to 0.85 as IP/USP, 0.65 to 0.85 as BP |
| Heavy metals | NMT 20 ppm as IP |
Microbiological Analysis
| Total Aerobic Microbial Count, CFU/g | NMT 1000 |
| Total Combined Yeasts & Molds Count, CFU/g | NMT 100 |
| Staphylococcus aureus, / g | Should be absent |
| Pseudomonas aeruginosa, / g | Should be absent |
| Escherichia coli, / g | Should be absent |
| Salmonella, /10g | Should be absent |
NMT: NOT MORE THAN | NLT: NOT LESS THAN | TAMC: TOTAL AEROBIC MIRCOBIAL COUNT | TYMC: TOTAL YEAST AND MOLD COUNT