Crospovidone-Containing Pellets are pharmaceutical-grade excipient-based multiparticulate pellets containing Crospovidone as one of the formulation components. Crospovidone is a cross-linked, water-insoluble homopolymer of N-vinyl-2-pyrrolidone and is widely used as a pharmaceutical excipient.
Crospovidone has CAS Number 9003-39-8 and molecular formula (C₆H₉NO)n. It is available in different grades, including Type A and Type B, which are differentiated by particle-size characteristics.
In pellet formulations, Crospovidone can be combined with other excipients to modify pellet structure, mechanical properties, porosity and processing characteristics. The resulting Crospovidone-containing pellets can be used as multiparticulate formulation components and may subsequently undergo coating or layering.
Crospovidone-Containing Pellets can be considered for:
Crospovidone is a cross-linked polymer, so its quantitative characterization differs from conventional active pharmaceutical ingredients. USP-NF specifies 11.0%–12.8% nitrogen on the dried basis for Crospovidone. It also specifies requirements for moisture, residue on ignition, pH and residual monomer.
Because the product is Crospovidone-Containing Pellets, the final formulation may contain other excipients. Therefore, the Crospovidone content, particle characteristics and finished-pellet quality parameters should be established according to the actual product specification.
Crospovidone-Containing Pellets can be supplied according to the required composition, Crospovidone grade, particle-size range, quantity, packaging configuration and applicable product specification. Appropriate packaging should protect the material from excessive moisture.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 11.0%–12.8% |
| Loss on Drying | NMT 5.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| Water Content | NMT 5.0% |