Pharmaceutical-Grade Donepezil HCl IR Pellets for Immediate-Release Oral Formulations
Donepezil HCl IR Pellets are multiparticulate pharmaceutical formulations designed for immediate-release oral dosage applications. The active ingredient is Donepezil Hydrochloride, identified by CAS Number 120011-70-3, with molecular formula C₂₄H₃₀ClNO₃ and molecular weight 416.0 g/mol.
The SDP pellet product portfolio lists Donepezil HCl IR Pellets in 10% and 16% strengths, providing two defined active-loading options for pharmaceutical formulation development.
The immediate-release pellet format provides a multiparticulate platform for oral formulation development, including suitable capsule-filling applications. Final release performance depends on the pellet composition, active loading, particle characteristics and applicable finished-product specification.
Donepezil Hydrochloride is the hydrochloride salt of Donepezil. PubChem identifies Donepezil Hydrochloride with CAS 120011-70-3, molecular formula C₂₄H₃₀ClNO₃, and molecular weight 416.0 g/mol.
Donepezil Hydrochloride Monohydrate is a distinct form with CAS 884740-09-4, molecular formula C₂₄H₃₂ClNO₄, and molecular weight 434.0 g/mol.
For the finished pellet product, the active-loading percentage should be distinguished from the purity assay of the raw material. The 10% and 16% values represent the specified pellet strengths listed for Donepezil HCl IR Pellets.
Donepezil HCl IR Pellets can be considered for:
Donepezil HCl IR Pellets can be supplied in suitable bulk packaging according to customer requirements. Strength, batch quantity, packaging configuration and applicable technical documentation can be specified according to the intended pharmaceutical formulation.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Loss on Drying | NMT 5.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 5.0% |