Pharmaceutical-Grade Fluoxetine EC Pellets for Enteric-Coated Oral Formulations
Fluoxetine EC Pellets are multiparticulate pharmaceutical formulations designed for enteric-coated oral dosage applications. The active ingredient is Fluoxetine Hydrochloride, identified by CAS Number 56296-78-7, molecular formula C₁₇H₁₉ClF₃NO, and molecular weight 345.79 g/mol. These chemical details are supported by USP reference-standard information and chemical databases.
Fluoxetine EC Pellets are available in 35% and 50% strengths in established pharmaceutical pellet product portfolios.
The enteric-coated pellet format uses a functional coating system to modify the release characteristics of the multiparticulate formulation. Published patent literature describes enteric-coated Fluoxetine formulations using methacrylic-acid-based coating polymers, demonstrating the technical basis for enteric coating of Fluoxetine multiparticulates.
Fluoxetine Hydrochloride is the hydrochloride salt of Fluoxetine. The standard material is identified by CAS 56296-78-7, with molecular formula C₁₇H₁₉ClF₃NO and molecular weight 345.79 g/mol.
Fluoxetine Hydrochloride is a racemic material containing both enantiomeric forms. The CAS number 56296-78-7 should therefore be used for the standard Fluoxetine Hydrochloride material rather than the CAS numbers assigned to individual enantiomers.
For the finished pellet product, the 35% and 50% values represent active ingredient loading and should not be interpreted as the purity assay of the Fluoxetine Hydrochloride raw material.
These strengths are consistently reported in multiple Indian pharmaceutical pellet product portfolios.
Fluoxetine EC Pellets can be considered for:
Fluoxetine EC 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 |
| Assay (HPLC) | 95.0% – 105.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |