Key Benefits & Why Formulators Choose NBE SOLUCEL™ Croscarmellose Sodium
Dual-Mechanism Disintegration:
Simultaneous swelling and wicking action delivers faster, more complete tablet disintegration than single-mechanism alternatives.
Effective at Low Levels:
Active at 1–5% w/w — preserving tablet volume for the API and reducing excipient cost.
Intra-granular and Extra-granular Use:
SOLUCEL® can be incorporated intra-granularly, extra-granularly, or both, allowing formulators to optimise disintegration profiles.
Excellent Chemical Stability:
Cross-linked structure ensures stability under typical processing and storage conditions.
Wide pH Activity:
Effective across the full pH range of the GI tract.
Multi-Pharmacopoeial:
Complies with USP-NF, BP, IP, and EP — accepted in all major regulated markets.
| Parameters | 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 |
| Type | Size |
|---|---|
| HDPE Bags | 25 Kg |
| HDPE Bags | 20 Kg |
| Paper Bags | 25 Kg |
| Paper Bags | 20 Kg |
| FIBC | 400 Kg |
| Container | Palletized | Non-Palletized |
|---|---|---|
| 20 Ft. (Approx Wt.) | 10,000 Kg | 12,000 Kg |
| 40 Ft. (Approx Wt.) | 20,000 Kg | 24,000 Kg |
| Parameter | Value |
|---|---|
| Composition | MCC (~98%) + Colloidal Silicon Dioxide (~2% w/w) |
| CAS Number (MCC) | 9004-34-6 |
| CAS Number (CSD) | 7631-86-9 |
| Appearance | White to off-white, odourless, free-flowing powder |
| pH (10% slurry) | 5.0 – 7.5 |
| Loss on Drying | NMT 7.0% |
| Bulk Density | 0.28 – 0.38 g/mL |
| Pharmacopoeial Standards | USP-NF (as SMCC), BP, IP |
Frequently Asked Questions
What is Croscarmellose Sodium used for in pharmaceuticals?
Croscarmellose Sodium is used as a superdisintegrant in pharmaceutical tablets and capsules. It promotes rapid disintegration of the dosage form after ingestion by absorbing water and swelling, and simultaneously wicking water into the tablet’s core. This accelerates drug release and dissolution, which is essential for fast-acting medications.
What is the difference between Croscarmellose Sodium and Sodium Starch Glycolate?
Both are superdisintegrants, but they differ in mechanism and application. Croscarmellose Sodium works through both swelling and wicking (dual mechanism) and is derived from cellulose. SSG works primarily through swelling and is derived from starch. Croscarmellose Sodium is often preferred for formulations where intra-granular incorporation is required, while SSG is frequently used in direct compression.
What is SOLUCEL® and how is it different from generic Croscarmellose Sodium?
SOLUCEL® is NB Entrepreneurs’ branded, consistently manufactured Croscarmellose Sodium product. Every batch of SOLUCEL® undergoes rigorous in-process and final product testing to ensure consistent particle size, degree of substitution, and swelling capacity. This consistency directly translates to reproducible disintegration performance in your formulation — batch after batch.
