CROSCARMELLOSE SODIUM

  1. Home
  2. Product

Automative parts & system

Download Doc

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.

DISOTAB - CROSCARMELLOSE SODIUM


TEST SPECIFICATION
Description/Appearance 1. A White or greyish-white powder
2. White or greyish-white hygroscopic powder
3. White, free-flowing powder
Solubility 1. Partially soluble in water; insoluble in alcohol, in ether, and in other organic solvents
2. Practically insoluble in acetone, in anhydrous ethanol and in toluene
Identification Test - A 1. Settles as a blue, fibrous mass
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
Identification Test - C A dense white precipitate is formed
pH Between 5.0 – 7.0
Sodium chloride & sodium glycolate NMT 0.5%
Water soluble substances NMT 10.0%
Loss on drying NMT 10.0%
Sulphated ash/ Residue on Ignition 14.0% to 28.0%
Settling volume 10.0 ml– 30.0 ml
Degree of substitution 0.60 to 0.85
Heavy metals NMT 20 ppm
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

APPLICATIONS IN PHARMACEUTICALS :

  • 1) In formulations as a disintegrant for capsules tablets and granules.
  • 2) In wet granulations, DISOTAB 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.
  • 3) Concentrations of normally 2% w/w is used in tablets in direct compression and 3% w/w in tablets in wet-granulation process.
  • 4) Suitable for products where the use of starch products is contraindicated.
  • 5) Works by attracting water into the tablet pores (wicking) followed by swelling.

WHY CHOOSE US?

  • 1 Producing various grades | Specification customization available.
  • 2 Heavily invested in R&D with lab instruments such as specific surface analyser, Gas chromatograph, Malvern etc
  • 3 Consistent excellence in product quality.
  • 4 An entirely automated facility, adhering to better hygiene & finished product quality.
  • Packaging – Standard packaging consists of 25 kg, with PP Bag or Paper Bag.
    (Customized packaging options available such as Fibre Drum or HDPE Drum etc.)
WhatsApp