Pantoprazole EC Pellets are pharmaceutical-grade enteric-coated multiparticulate pellets containing Pantoprazole, commonly supplied in the form of Pantoprazole Sodium, as the active ingredient. Pantoprazole Sodium is available as the sesquihydrate form with CAS Number 164579-32-2, molecular formula C₁₆H₁₄F₂N₃NaO₄S · 1.5H₂O, and molecular weight 432.37 g/mol. Pantoprazole itself has CAS 102625-70-7, molecular formula C₁₆H₁₅F₂N₃O₄S, and molecular weight 383.38 g/mol.
Pantoprazole is sensitive to acidic conditions, making an enteric-coated multiparticulate system suitable for formulations where protection from gastric acidity and delayed release are required. The pellet system generally consists of an active-loaded core followed by functional coating layers designed to provide acid resistance and the required release profile.
Pantoprazole EC Pellets manufacturer in India products are suitable for capsule filling, multiparticulate oral dosage forms and formulation development. Commercially documented Pantoprazole EC pellet strengths include 8.5%, 10%, 15%, 20%, 22.5% and 24%, depending on the manufacturer and formulation. These market values should not automatically be presented as SDP-available strengths unless confirmed against the current SDP product specification.
The final pellet specification should control active loading, assay, related substances, moisture, pellet size, enteric coating characteristics, acid resistance and dissolution performance. This provides flexibility for pharmaceutical manufacturers developing delayed-release oral formulations.
Pantoprazole EC Pellets are designed for oral formulations requiring protection of the active ingredient from acidic gastric conditions.
The multiparticulate pellet format is suitable for incorporation into capsule dosage forms according to the required formulation and active loading.
The functional enteric coating is designed to provide acid resistance followed by release under appropriate gastrointestinal conditions.
Pantoprazole EC Pellets can be used as a formulation intermediate for development, optimization and scale-up of oral multiparticulate products.
The pellets can be supplied for bulk formulation requirements with product-specific active loading, pellet size and release 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 1.0% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.20% |
| Total Impurities | NMT 0.50% |
| Water Content | 5.0–8.0% |