Crospovidone Pellets are pharmaceutical-grade excipient pellets containing Crospovidone, a cross-linked, water-insoluble homopolymer of N-vinyl-2-pyrrolidone. Crospovidone is widely used as a pharmaceutical excipient and can also function as a pelletization aid in multiparticulate formulation development. USP identifies Crospovidone as (C₆H₉NO)n, CAS 9003-39-8, with two grades, Type A and Type B, based on particle-size characteristics.
Crospovidone-based pellet systems can be developed using extrusion-spheronization and related pelletization processes. Published research has demonstrated Crospovidone's use as a pelletization aid and reported its ability to produce rapidly disintegrating/releasing pellet systems.
Crospovidone Pellets can be considered for:
Crospovidone is a water-insoluble synthetic cross-linked homopolymer of N-vinyl-2-pyrrolidone. USP specifies nitrogen content of 11.0%–12.8% on the dried basis.
Crospovidone is available in Type A and Type B, differentiated by particle-size characteristics.
For finished Crospovidone Pellets, the pellet specification should be distinguished from the raw-material Crospovidone monograph. Parameters such as pellet size, mechanical properties, moisture and formulation composition are product-specific.
Crospovidone Pellets can be supplied according to the required grade, particle-size range, quantity, packaging configuration and applicable product specification. Crospovidone should be protected from moisture during storage.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 11.0%–12.8% on dried basis |
| Loss on Drying | NMT 5.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.0–8.0 |
| Water Content | NMT 5.0% |