Rabeprazole Sodium EC Pellets are pharmaceutical-grade enteric-coated multiparticulate pellets containing Rabeprazole Sodium. Rabeprazole Sodium has the anhydrous molecular formula C₁₈H₂₀N₃NaO₃S, molecular weight 381.42 g/mol, and CAS Number 117976-90-6. USP specifies Rabeprazole Sodium at 98.0–102.0%, calculated on the dried basis for the anhydrous material or anhydrous basis for the hydrated form.
Rabeprazole Sodium is sensitive to acidic conditions. Enteric-coated pellet technology is therefore used to provide acid resistance followed by release under suitable gastrointestinal conditions. Published formulation work has demonstrated Rabeprazole Sodium pellets with an enteric coating designed around a pH-dependent dissolution threshold, including coatings based on polymers that dissolve at approximately pH 5.5 and above.
Commercial Rabeprazole Sodium EC pellet products are available in several active loadings. Documented commercial strengths include 7.5%, 8.5%, 15%, 20%, 22.5% and 25% w/w, depending on the manufacturer and formulation.
For SDP, the final published strength should be taken from the current SDP product specification or COA rather than assuming the entire commercial range.
Rabeprazole Sodium EC Pellets are designed for formulations requiring protection from acidic gastric conditions.
The multiparticulate pellet format is suitable for incorporation into capsule dosage forms according to the required strength and formulation specification.
The enteric coating provides acid resistance followed by release under the defined pH conditions.
The pellets can be used as a formulation intermediate for development, optimization and manufacturing of oral multiparticulate products.
Rabeprazole Sodium EC Pellets can be supplied for bulk formulation requirements with product-specific loading, pellet size, coating and dissolution specifications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 5.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 5.0% |