Empowering Quality Control with Croscarmellose Sodium Analysis Excellence

Croscarmellose sodium is an odorless white powder and a crosslinked, partially carboxymethylated sodium salt of cellulose, or a crosslinked polymer of sodium carboxymethyl cellulose. Croscarmellose sodium is often regarded as an essentially non-toxic, non-irritating pharmaceutical excipient. CD BioGlyco provides custom croscarmellose sodium analysis services to our clients with cutting-edge Pharmaceutical Excipient Analysis technology.

• Properties
  Croscarmellose sodium is a white or off-white powder that dissolves and forms a suspension in water and is insoluble in anhydrous ethanol, ether, acetone, or toluene.
• Identification
  • If a blue precipitate appears after the addition of an appropriate amount of methylene blue solution to the sample, the sample is croscarmellose sodium.
  • After adding water, α-naphthol methanol solution, anhydrous methanol, and sulfuric acid to the sample, a purplish-red color will appear at the junction of the liquid levels if the sample is croscarmellose sodium.
• Acidity
  The acidity of croscarmellose sodium is tested using a pH meter. The pH of croscarmellose sodium should be 5.0 to 7.0.
• Sedimentation volume
  An appropriate amount of water is added to croscarmellose sodium in portions, and shaken, after a while, the settling volume is measured.
• Degree of substitution calculation
  We utilize the acid-base titration method to calculate the degree of substitution of carboxymethyl acid with sodium carboxymethyl in croscarmellose sodium. Throughout the titration, we use hydrochloric acid and sodium hydroxide solution as the titrant for the two titration processes and m-cresol violet as the indicator solution, respectively.
• Sodium chloride content
  We titrate croscarmellose sodium using silver nitrate solution as titrant and indicate the titration endpoint by silver electrode potentiometric method. In this case, each 1 ml of silver nitrate titrant (0.05 mol/L) is equivalent to 2.922 mg of sodium chloride.
• Croscarmellose sodium ethanoate content
  We measure the absorbance of the acetone solution of croscarmellose sodium at 540 nm using ultraviolet-visible spectrophotometry with a standard solution of ethanoic acid as a control and then calculate the content of sodium ethanoate in croscarmellose sodium.
• Loss on drying
  The croscarmellose sodium is dried at 105°C for several hours with a weight loss of not more than 10.0%.
• Cauterization of the residue
  The croscarmellose sodium is subjected to thorough cauterization. The residue remaining of croscarmellose sodium should constitute 14.0% to 28.0% of the total amount, based on the dried product.

Publication Data

Frequently Asked Questions

• What is croscarmellose sodium?
  Croscarmellose sodium is a cross-linked polymerized fibrous ether produced by chemical modification of natural cellulose, the structure of which is mainly composed of D-glucose units connected by β(1→4) glycosidic bonds.
• What is the function of croscarmellose sodium?
  Croscarmellose sodium refers to a good pharmaceutical excipient that can be used as an excipient, disintegrant, or disintegration aid. In oral dosage forms, croscarmellose sodium is used as a disintegrant in capsules, tablets, and granules. In tablets, croscarmellose sodium is suitable for direct compression and wet granulation tableting processes. In addition, croscarmellose sodium can be used as a disintegrant at concentrations up to 5%.

Advantages

• CD BioGlyco has cutting-edge analysis tools and technologies to efficiently and accurately examine the nature, structure, and function of Pharmaceutical and Biological.
• CD BioGlyco offers custom croscarmellose sodium analysis services based on client needs and has excellent project management capabilities to ensure on-time project delivery.
• CD BioGlyco offers croscarmellose sodium analysis services suitable for food processing, pharmaceutical research, and many other areas.

CD BioGlyco provides efficient, accurate croscarmellose sodium analysis services that are customized to meet the needs of our clients. Please feel free to contact us for more information about our pharmaceutical excipient analysis services.