Diclofenac Potassium SR Pellets (CAS No: 15307-81-0)
Pharmaceutical-Grade Sustained Release Pellets for Oral Dosage Forms
Diclofenac Potassium SR Pellets are pharmaceutical sustained-release multiparticulate pellets containing Diclofenac Potassium, designed for modified-release oral dosage-form applications. These pellets can be used as pharmaceutical formulation intermediates for sustained-release capsules and other suitable multiparticulate oral dosage forms where controlled drug release is required.
Diclofenac Potassium is the potassium salt of diclofenac and is identified by CAS Number 15307-81-0. The compound has the molecular formula C₁₄H₁₀Cl₂KNO₂ and a molecular weight of 334.24 g/mol. The USP monograph defines Diclofenac Potassium as containing 99.0%–101.0% of diclofenac potassium on the dried basis for the API. This API assay should not be confused with the drug loading of finished Diclofenac Potassium SR Pellets.
Diclofenac Potassium SR Pellets are designed as multiparticulate systems in which formulation and release-controlling components can be used to establish the desired sustained-release characteristics. Commercial pharmaceutical pellet manufacturers currently list Diclofenac Potassium SR Pellets with different drug-loading levels, demonstrating that the final pellet composition is formulation-specific.
Diclofenac Potassium SR Pellets can be supplied in suitable pharmaceutical packaging for formulation development and bulk manufacturing applications. Packaging configuration, drug loading, pellet characteristics, dissolution profile, quantity and storage requirements should be confirmed according to the applicable product specification and customer requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |