Choline Fenofibrate SR Pellets are pharmaceutical-grade sustained-release multiparticulate pellets containing Choline Fenofibrate as the active ingredient. Choline Fenofibrate is the choline salt of fenofibric acid and has CAS Number 856676-23-8, molecular formula C₂₂H₂₈ClNO₅, and molecular weight 421.91 g/mol. USP defines Choline Fenofibrate as containing 97.0%–103.0%, calculated on the anhydrous basis.
The sustained-release pellet format is designed to provide controlled release of the active ingredient over an extended period. The release profile can be regulated through suitable matrix or functional coating technology, with the final performance depending on active loading, pellet size, coating characteristics and formulation composition.
Choline Fenofibrate is a relatively specialized pharmaceutical ingredient, and reliable public documentation for a universal commercial strength specifically for Choline Fenofibrate SR Pellets is limited. Therefore, an unsupported pellet percentage should not be added to the SDP page. The exact active loading should be taken from the current SDP specification or COA.
Choline Fenofibrate SR Pellets can be positioned for multiparticulate oral formulation development, capsule filling, sustained-release formulation manufacturing and bulk pharmaceutical supply. Product-specific specifications should define assay, moisture, impurities, pellet-size distribution and dissolution/release requirements.
Choline Fenofibrate SR Pellets are designed for oral formulations requiring controlled release of the active ingredient.
The multiparticulate format is suitable for incorporation into capsule dosage forms according to the selected formulation and active loading.
Individual pellets provide a flexible platform for developing sustained-release oral formulations with controlled release characteristics.
The pellets can be used as a formulation intermediate for pharmaceutical manufacturers developing sustained-release products.
Choline Fenofibrate SR Pellets can be supplied in bulk according to the approved active loading and finished-product quality specification.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0–103.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.15% |
| Heavy Metals | NMT 10 ppm |
| Total Impurities | NMT 0.50% |
| Water Content | NMT 1.0% |