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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.
| 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 | ||
| Container | Palletized | Non-Palletized |
|---|---|---|
| 20 Ft. (Approx Wt.) | 10,000 Kg | 12,000 Kg |
| 40 Ft. (Approx Wt.) | 20,000 Kg | 24,000 Kg |
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Dadri, Gautam Buddha Nagar, Uttar Pradesh 
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