Pharmaceutical-Grade Sertraline IR Pellets for Immediate-Release Oral Formulations
Sertraline IR Pellets are multiparticulate pharmaceutical formulations designed for immediate-release oral dosage applications. The active ingredient is Sertraline Hydrochloride, identified by CAS Number 79559-97-0, with molecular formula C₁₇H₁₇Cl₂N·HCl (C₁₇H₁₈Cl₃N) and molecular weight 342.69 g/mol. These identifiers are supported by the USP-NF monograph and PubChem.
The SDP pellet product portfolio lists Sertraline IR Pellets in 25% and 50% strengths, providing multiple active-loading options for pharmaceutical formulation development.
The immediate-release pellet format provides a multiparticulate platform intended to release the active ingredient according to the specified formulation profile. Pellet composition, active loading, particle characteristics and manufacturing parameters influence final release performance.
Sertraline Hydrochloride is the hydrochloride salt of the S-enantiomer of sertraline. The USP monograph identifies the material as C₁₇H₁₇Cl₂N·HCl, molecular weight 342.69 g/mol, and CAS 79559-97-0. USP specifies Sertraline Hydrochloride at 97.0%–102.0%, calculated on the anhydrous basis.
For the finished Sertraline IR Pellets, the 25% and 50% values represent active ingredient loading and should not be confused with the purity assay of Sertraline Hydrochloride API.
Sertraline IR Pellets can be considered for:
Sertraline 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 |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |