Microcrystalline Cellulose-Containing Pellets are pharmaceutical excipient-based multiparticulate pellets in which microcrystalline cellulose (MCC) is incorporated as one component of the pellet formulation. Unlike pure Microcrystalline Cellulose Pellets, the term “containing” does not indicate that MCC represents 100% of the finished pellet composition.
Microcrystalline cellulose is a purified, partially depolymerized cellulose excipient identified by CAS Number 9004-34-6 and polymeric formula (C₆H₁₀O₅)n. It is widely used in pharmaceutical formulations because of its useful binding, water-retention and pelletization characteristics.
The International Pharmacopoeia specifies MCC with a degree of polymerization not exceeding 350, loss on drying not more than 6.0%, sulfated ash not more than 0.1%, heavy metals not more than 10 ppm, and pH 5.0–7.5 under the specified test conditions. These values describe the MCC excipient and should not automatically be applied to the complete finished pellet.
Microcrystalline Cellulose-Containing Pellets can be considered for:
The final properties depend on the MCC percentage, other excipients, binder system, pelletization process and intended application.
Therefore, the finished-product specification should establish MCC loading, particle-size distribution, moisture, bulk density, friability and mechanical properties specifically for the formulation.
Microcrystalline Cellulose-Containing Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. MCC content, pellet size, composition, packaging configuration and finished-product specifications should be confirmed against the applicable product specification and COA.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0% – 100.0% |
| Loss on Drying | NMT 6.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.0–7.5 |
| Water Content | NMT 6.0% |