Dutasteride Pellets are pharmaceutical-grade multiparticulate pellets containing Dutasteride as the active ingredient. These pellets are designed for incorporation into oral dosage formulations and provide formulation flexibility through controlled active-ingredient loading and pellet-based dosage-form development.
Dutasteride has the molecular formula C₂₇H₃₀F₆N₂O₂, molecular weight 528.5 g/mol, and CAS Number 164656-23-9, as reported by PubChem.
Dutasteride pellets are available from pharmaceutical pellet manufacturers in different active-loading levels. Published industry product lists show examples such as 0.25% and 0.5% w/w, although the exact strength for an individual supplier should be confirmed against its current product specification.
The exact SDP strength should be entered according to the current approved product specification. Do not automatically use competitor strengths as the SDP strength.
Published Indian pellet portfolios commonly list Dutasteride Pellets at 0.25% and 0.5% w/w.
Dutasteride Pellets can be considered for:
Dutasteride is a synthetic steroidal compound with the molecular formula C₂₇H₃₀F₆N₂O₂. PubChem reports a molecular weight of 528.5 g/mol and CAS Number 164656-23-9.
The finished Dutasteride pellet is a formulation system rather than the neat active ingredient. Therefore, parameters such as assay, moisture, impurities, pellet appearance and other quality characteristics should be evaluated against the finished-pellet product specification.
Dutasteride Pellets can be supplied according to the required strength, batch quantity, packaging configuration and applicable product specifications. Packaging should provide suitable protection from moisture and environmental exposure during storage and transportation.
| 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 1.0% |