Croscarmellose sodium is a kind of white to milky white, finely dispersed, almost odorless, and odorless hygroscopic powder that is insoluble in water and ordinary solvents. It has strong hydrophobicity, high water absorption, and expands when exposed to water.
CAS No. :
74811-65-7EINECS :
1312995-182-4Package :
25KG/DRUMBrand :
TOPINCHEM®Origin :
CHINAMinimum Order :
200KGItem :
Croscarmellose SodiumCroscarmellose Sodium Pharmaceutical Grade CAS 74811-65-7
Description
Croscarmellose sodium is a white powder with excellent properties such as disintegration, suspension, and non toxicity. Due to the presence of cross-linking bonds, it is insoluble in water and has strong hygroscopicity in water.
Specification
| Tests | Specification | Result |
| Identification | A.The Croscarmellose Sodium absorbs the methylene blue and settles as a blue,fibrous mass. | Consistents with the regulations |
| B. Incline the test tube,and carefully add 2 mL of sulfuric acid down the side so that it forms a lower layer: a reddish-violet color develops at the interface | Consistents with the regulations | |
| C. A portion of the mixture of Croscarmellose Sodium with water, prepared as directed in Identification B, imparts an intense yellow color to a nonluminous flame | Consistents with the regulations | |
| pH | 5.0～7.0 | 6.7 |
| Settling Volume | The volume of the settled mass is 10.0～30.0 mL | 15.5ml |
| Degree of Substitution | The degree of substitution is 0.60～0.85 on the dried basis | 0.78 |
| Sodium Cholride and Sodium Glycolate | The sum of the percentages of sodium chloride and sodium glycolate is NMT 0.5% | 0.02% |
| Content of Water-Soluble Material | NMT 10.0% | 4.66% |
| Loss on Drying | NMT 10.0% | 1.63% |
| Residue on Ignition | 14.0%～28.0% | 19.70% |
| Microbial Enumeration Tests and Tests Fot Specified Microorganisms | The total aerobic microbial count does not exceed 1000 cfu/g | <10cfu/g |
| The total combined molds and yeasts count does not exceed 100 cfu/g. | <10cfu/g | |
| It meets the requirements of the test for absence of Escherichia coli. | Absence |
Application
Croscarmellose sodium is used as a disintegrant for tablets, capsules, and granules in oral formulations, relying on capillary and swelling effects to achieve disintegration. Its characteristics are good compressibility and strong disintegration force.
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