Croscarmellose sodium

Product Details

CasNo： 74811-65-7

MF： C28H36O26Na4

Appearance： powder

Delivery Time： 15 days

Packing： 25kg/bag

Purity： 99%

• Basic Information
  • Generic Name: Croscarmellose Sodium
  • English Name: Croscarmellose Sodium (CCNa)
  • Chemical Name: Cellulose, carboxymethyl ether, sodium salt, crosslinked
  • CAS No. : 74811 - 65 - 7
  • Molecular Formula: C28H36O26Na4
  • Appearance: Colorless, white or off - white powder.
• Physicochemical Properties
  • Solubility: Insoluble in water, but it will rapidly swell to 4 - 8 times its original volume when in contact with water. It is also insoluble in anhydrous ethanol, diethyl ether, acetone or toluene.
  • Stability: It has stable chemical properties, but is hygroscopic.
  • Other Properties: The adhesion index is 0.0456, and the friability index is 0.1000.
• Preparation Method
  • Cellulose derived from wood pulp or cotton fiber is impregnated in sodium hydroxide solution, and then the alkalized cellulose reacts with sodium monochloroacetate to obtain sodium carboxymethyl cellulose. After the substitution reaction is completed and the sodium hydroxide is exhausted, the excess sodium monochloroacetate is slowly hydrolyzed into glycolic acid. Glycolic acid converts part of the sodium carboxymethyl groups into free acids and catalyzes the cross - linking to produce croscarmellose sodium. Then, croscarmellose sodium is extracted with alcohol - water to remove the residual sodium chloride and sodium glycolate. After purification, the purity of croscarmellose sodium is greater than 99.5%. It can be ground to reduce the length of polymer fibers, thereby improving fluidity.
• Quality Standards
  • pH Value: 5.0 - 7.0
  • Loss on Drying: ≤10.0%
  • Settling Volume: 10.0 - 30.0ml
  • Residue on Ignition: 14.0% - 28.0%
  • Degree of Substitution: 0.60 - 0.85
  • Water - soluble Substances: 1.0% - 10.0%
  • Sodium Chloride and Sodium Glycolate: ≤0.5%
  • Heavy Metals: ≤10ppm
  • Arsenic Salt: ≤0.0002%
  • Microbiological Limits and Residual Organic Solvents: Meet the specified requirements.
• Functions and Uses
  • It is used as a disintegrant for tablets, capsules and granules in oral preparations, and plays a disintegration role by capillary and swelling effects. It has the characteristics of good compressibility and strong disintegration force, which can significantly improve the disintegration and dissolution performance of drugs. It can also be applied to nutritional health products.
• Usage and Dosage
  • It is suitable for direct - compression and wet - granulation tableting processes. When used as a disintegrant, the dosage can reach 5.0% (W/W), but usually the dosage is 2.0% (W/W) in the direct - compression process and 3.0% (W/W) in the wet - granulation process.
• Storage Conditions
  • It should be stored in a closed container in a cool and dry place.
• Compatibility Taboos
  • It has compatibility taboos with strong acids and soluble salts of iron or other metals (such as aluminum, mercury, zinc). In addition, in both wet - granulation and direct - compression processes, the presence of hygroscopic excipients (such as sorbitol) may slightly reduce the disintegration efficiency of this product.
• Safety
  • It is generally considered non - toxic and non - irritating, but may cause slight irritation to the eyes. A large amount of oral administration may have a laxative effect, but the dosage in solid preparations is not likely to cause this problem.