Fluconazole IR Pellets are pharmaceutical-grade multiparticulate pellets containing Fluconazole and designed for immediate-release oral dosage-form development. The pellet format provides a flexible platform for capsule filling and other multiparticulate formulation applications.
Fluconazole has CAS Number 86386-73-4, molecular formula C₁₃H₁₂F₂N₆O, and molecular weight 306.27 g/mol. The current USP-NF monograph specifies Fluconazole at 98.0%–102.0% calculated on the dried basis.
Fluconazole IR Pellets are commercially available in the Indian pharmaceutical pellet market. Published commercial listings report different active-ingredient loadings, including 25%, 40%, 41.6% and 60%, depending on the manufacturer and formulation. This variation means that active loading should be treated as product-specific and should not be presented as an SDP specification unless confirmed by the applicable SDP product documentation.
Fluconazole Immediate-Release Pellets are formulated to provide an appropriate release profile for immediate-release oral formulations. The final performance depends on the active loading, excipient composition, pellet size, manufacturing process and other formulation parameters.
The pellet format can provide a practical intermediate for capsule filling and multiparticulate dosage-form development. Commercial product references specifically list Fluconazole IR Pellets, confirming that this formulation format is used within the pharmaceutical pellet market.
Fluconazole IR Pellets can be considered for:
Fluconazole IR Pellets may be manufactured using suitable pelletization, layering or other multiparticulate processing technologies.
Important product parameters can include:
The final limits should be established through the applicable finished-pellet product specification.
Fluconazole IR Pellets may be evaluated for:
The USP-NF Fluconazole API monograph specifies 98.0%–102.0% assay on the dried basis. This is an API reference specification, not automatically the acceptance range for finished Fluconazole IR Pellets.
Fluconazole Pharmaceutical Pellets provide a multiparticulate platform for formulation developers requiring a convenient pellet intermediate for oral dosage-form development.
The Fluconazole IR pellet format can be suitable where immediate release is the intended formulation characteristic. Active loading, particle size, moisture and dissolution requirements should be established according to the individual finished-product specification.
Fluconazole IR Pellets can be supplied in suitable pharmaceutical bulk packaging according to the applicable product specification. Active loading, pellet size, packaging configuration and analytical requirements should be confirmed before commercial supply.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 1.0% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 2.0% |