Description
A co-processed combination of microcrystalline cellulose with a small fraction of carmellose sodium that self-disperses under shear to form a stable three-dimensional colloidal gel. Used in pharmaceutical oral liquids, suspensions, and topical systems as a suspending agent, viscosity modifier, and texture builder.
White to off-white free-flowing powder. On hydration under high shear it forms a thixotropic gel network of cellulose microcrystals with characteristic dimensions on the order of 0.2 microns, providing yield stress, heat stability, and acid tolerance that native MCC cannot match.
We supply pharmaceutical-grade Colloidal Microcrystalline Cellulose from manufacturers in China holding ISO, GMP, USP/EP/JP DMF, Halal, Kosher, and other certifications relevant to the product and production.
Common market grades are differentiated by MCC-to-CMC ratio (typically 85:15 to 92:8), viscosity in dispersion, and intended functionality (suspension, foam stabilization, heat-shock resistance, protein stabilization). Pharmaceutical grades are produced on segregated lines and supported by full pharmacopoeial documentation.
Bulk and reduced-MOQ shipments. Batch-level COA covering MCC and CMC content, loss on drying, pH, viscosity in dispersion, colloidal fraction, particle size, heavy metals, and microbiology against USP, EP, JP, and BP monographs.
Introduction
Colloidal Microcrystalline Cellulose was developed in the 1960s as a co-processed excipient that overcomes the principal limitation of native MCC for liquid systems: native MCC is insoluble and sediments rapidly, while co-processing with a small fraction of carmellose sodium produces a self-dispersing system that forms a stable colloidal gel under shear.
Production begins with pharmaceutical-grade MCC that is wet-blended with carmellose sodium in a controlled mass ratio, co-processed by attrition and spray drying, and milled to a defined particle size. The CMC fraction prevents the cellulose microcrystals from re-aggregating during drying, preserving the colloidal dispersibility of the finished excipient.
The dispersed gel is thixotropic with a yield stress that supports particles of any density indefinitely, heat-stable to 120 degrees Celsius (which is essential for retort-sterilized pharmaceutical liquids), and acid-tolerant from pH 3.0 to 9.0. These properties together explain its dominance in pharmaceutical suspension formulation where physical stability over shelf life is a regulatory requirement.
Listed in USP-NF and EP under the Cellulose, microcrystalline and carmellose sodium monograph and supported by FDA DMFs from major manufacturers. Used in oral, topical, and ophthalmic preparations.
Strategic position: the standard suspending excipient for ready-to-use and reconstituted pharmaceutical liquid suspensions, particularly antibiotic suspensions and pediatric formulations.
Where it is used
- Suspending agent in pharmaceutical oral suspensions and syrups
- Viscosity builder for poorly soluble API suspensions
- Heat-shock stabilizer in reconstituted antibiotic suspensions
- Texture builder in pediatric oral liquid formulations
- Foam and emulsion stabilizer in topical pharmaceutical creams
- Carrier in nutraceutical oral suspensions and shots
- Body and mouthfeel modifier in liquid OTC products
- Stabilizer for protein-containing liquid pharmaceutical preparations
Technical data
| Item | Specification |
|---|---|
| Appearance | White to off-white powder |
| Compliance | USP/NF, EP current edition |
| Identification | Conforms to pharmacopoeial tests |
| Microcrystalline cellulose content | ≥ 85.0% |
| CMC-Na content | 8% to 18% |
| Loss on drying | ≤ 8.0% |
| pH (1.2% dispersion) | 6.0 to 8.0 |
| Viscosity (1.2% dispersion, 25 °C) | 40 to 200 mPa·s (grade dependent) |
| Colloidal fraction | ≥ 60% |
| Heat stability | Stable to 120 °C |
| Particle size (D50, dispersed) | ≤ 5 microns |
| Heavy metals (as Pb) | ≤ 10 mg/kg |
| Arsenic | ≤ 3 mg/kg |
| Total aerobic count | ≤ 1,000 CFU/g |
| Yeast and mould | ≤ 100 CFU/g |
| E. coli, Salmonella | Absent |
| Source | Purified wood pulp cellulose, co-processed with CMC-Na |
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