Diclofenac Sodium EC Pellets (CAS No: 15307-79-6)
Pharmaceutical-Grade Enteric Coated Pellets for Oral Dosage Forms
Diclofenac Sodium EC Pellets are pharmaceutical-grade enteric-coated multiparticulate pellets containing Diclofenac Sodium, formulated to resist dissolution in gastric acid and release the drug in the intestinal environment. This enteric-coating approach is used to reduce direct gastric mucosal exposure to the drug and support gastro-resistant oral dosage forms. Diclofenac Sodium has the molecular formula C₁₄H₁₀Cl₂NNaO₂ and a molecular weight of approximately 318.1 g/mol (source: PubChem).
Enteric-coated Diclofenac Sodium pellets are typically produced by layering the drug onto an inert or drug-crystal core, followed by application of a pH-dependent enteric polymer coat, with the coating level and polymer system determined by the target gastro-resistance and dissolution profile.
Key Features
Applications
Why Choose Diclofenac Sodium EC Pellets?
Packaging & Supply
Diclofenac Sodium EC Pellets can be supplied in suitable pharmaceutical packaging for formulation development and bulk manufacturing applications. Packaging configuration, drug loading, coating level, 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 2.0% |
| Residue on Ignition | NMT 1.0% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.2% |
| Total Impurities | NMT 0.5% |
| Water Content | NMT 2.0% |