Crospovidone-Based Pellets are pharmaceutical-grade excipient pellets formulated with Crospovidone as a major functional component. Crospovidone is a cross-linked, water-insoluble homopolymer of N-vinyl-2-pyrrolidone and is widely used as a pharmaceutical excipient. It can also be used as a pelletization aid in multiparticulate formulation development.
Crospovidone has the CAS Number 9003-39-8 and molecular formula (C₆H₉NO)n. Pharmacopoeial specifications identify Crospovidone by infrared identification and control its nitrogen content, moisture, ash, pH and residual monomer levels.
Crospovidone-based pellet systems can be produced using pelletization techniques such as extrusion-spheronization. The resulting pellets may be used as excipient-based cores for subsequent coating, layering or other pharmaceutical formulation processes.
Crospovidone-Based Pellets can be considered for:
Crospovidone is a cross-linked polymer rather than a conventional low-molecular-weight active ingredient. It is therefore more appropriate to specify its quality using nitrogen content, loss on drying, residue on ignition, pH and residual 1-vinyl-2-pyrrolidinone rather than an API-style HPLC assay.
USP-NF identifies Crospovidone as (C₆H₉NO)n and specifies 11.0%–12.8% nitrogen on the dried basis. Crospovidone is also classified into Type A and Type B according to particle-size characteristics.
Crospovidone-Based Pellets can be supplied according to the required grade, particle-size range, quantity, packaging configuration and applicable product specification. Appropriate packaging should protect the material from excessive moisture during storage and transportation.
| 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% |