Croscarmellose sodium is a cross linked polymer of carboxy methyl cellulose sodium and used in pharmaceutical formulation as a disintegrant. Croscarmellose sodium occurs as an odorless, white or grayish white powder.
Disintegrants facilitate the breakup of a tablet in the intestinal tract after oral administration. Cross-linking allows enhanced bioavailability of the drug through superior drug dissolution. Without a disintegrant, tablets may not dissolve appropriately and may affect the amount of active ingredient absorbed, thereby decreasing effectiveness.
ADVANTAGES
- Fast disintegration & dissolution
- Better stability
- Good Flowability and mixing properties
- Facilitate breakup of tablets
APPLICATIONS
- It is used in oral pharmaceutical formulations as a disintegrant for capsules, tablets and Granules
- It is used in both direct-compression and wet-granulation processes
UNIQUE FEATURES of SANCEL
- Greater level of dissolution of tablets
- Excellent API stability
- Cost-effectiveness
- GMO Free
Product Specification
| Compendial Standards | USP – NF | BP | |||
| Description | Fine to coarse, White or off White, free flowing Powder, Odourless or almost odourless | White or greyish white powder | |||
| Identification A, B,C | Complies | Complies | |||
| pH | 5.0 – 7.0 | 5.0 – 7.0 | |||
| Loss on Drying % | NMT 10 | NMT 10 | |||
| Sodium Chloride and Sodium Glycolate, Sum % | NMT 0.5 | NMT 0.5 | |||
| Heavy Metals, PPM | NMT 10 | NMT 20 | |||
| Degree of Substitution | 0.60 to 0.85 | 0.60 to 0.85 | |||
| Water Soluble Material % | NMT 10.0 | NMT 10.0 | |||
| Settling Volume, ml | 10 to 30 | 10 to 30 | |||
| Residue on Ignition, % | 14 to 28 | 14 to 28 | |||
| Microbiology Limits: | |||||
| Total Aerobic Microbial Count, cfu/g | NMT 1000 | NMT 1000 | |||
| Total Yeast And Mold Count, cfu/g | NMT 100 | NMT 100 | |||
| Escherichia Coli | Absent in 1g Sample | Absent in 1g Sample | |||
| Salmonella Species | Absent in a 10g Sample | Absent in a 10g Sample | |||
| Pseudomonas Aeruginosa | Absent in 1g Sample | Absent in 1g Sample | |||
| Staphylococcus Aureus | Absent in 1g Sample | Absent in 1g Sample | |||
Packaging Details
Available Packaging Type
| Type | Size |
| HDPE Bags | 25 Kg |
| HDPE Bags | 20 Kg |
| Paper Bags | 25 Kg |
| Paper Bags | 20 Kg |
| FIBC | 300 Kg |
*Our standard packaging is in 25 kg Bags. We can also customize packaging as per customers request at additional cost.
| Container | Palletized | Non-Palletized |
|---|---|---|
| 20 Ft. (Approx Wt.) | 10,000 Kg | 12,000 Kg |
| 40 Ft. (Approx Wt.) | 20,000 Kg | 24,000 Kg |