TekLeu® CSS is an insoluble and hydrophilic polymer with excellent water uptake and rapid swelling properties; supporting faster disintegration and drug dissolution at lower use levels (1-2%).
CAS# 74811-65-7
EINECS # 1312995-182-4
Croscarmellose sodium is a commonly used pharmaceutical excipient, primarily employed as a disintegrant in oral dosage forms. It's a cross-linked sodium carboxymethylcellulose and is derived from wood pulp or cotton.
In simple terms, when you take a tablet containing croscarmellose sodium orally, it helps the tablet to break apart or disintegrate rapidly in the gastrointestinal tract, allowing the active ingredients to be released and absorbed efficiently. This is particularly important for drugs that are formulated into tablets or capsules, as it ensures they can dissolve quickly and be absorbed into the bloodstream for therapeutic effect.
Features & Benefits
■ Super disintegrant
■ Superior performance at lower concentration
■ High-purity
■ Broad functionality
■ Improved cost performance
Storage & Handling
This product has strong hygroscopicity. It should be stored in a sealed, cool and dry place. Packing: 25kg drum
Safety
Safety Data Sheet has been compiled for Croscarmellose Sodium (TekLeu® CSS) that contains up-to-date information on questions relevant to safety.
Regulatory
DMF,CEP,GMP
This product is usually used as a disintegrating agent for capsules, tablets and granules, e.g.Finasteride Dispersible Tablets
■ Its water-swelling capacity is better than that of low-substituted sodium carboxymethyl cellulose and microcrystalline cellulose, and has better disintegrating effect, e.g. Triazolam Pulse Tablets
■ In tablets, this product is suitable for direct tableting and wet granulation. In wet granulation, internal and external processes can be used to better display the disintegration effect.
■ Generally the concentration of it is up to 5% (W/W) used as a disintegrating agent, the usual amount of direct tableting is about 2% (W/W), the usual amount of wet granulation is about 3% (W/W).
■ For hydrophobic auxiliary (such as calcium phosphate) compressed tablets, the disintegration effect is better, the minimum 0.5% (W/W) can exert the disintegration effect. However, when methyl cellulose is as a binder, it will prolong the disintegration time of this product. The greater the viscosity of methyl cellulose, the longer the extension time.
■ this product can be used for swelling materials of pulse preparations, solid dispersion carriers, gastrointestinal dwelling bioadhesive drug release systems, etc.
Pyhsical Properties
Standard | CP2020/USP43-NF38/EP10.0 |
Whiteoroff-whitepowder; | |
Hygroscopic | |
Ethanol | NMT0.01% |
pH | 5.9-7.0 |
Lossondrying | NMT6.0% |
Controlledparticlesize | D10:25ummax |
D50:25-55um | |
D90:60ummax |