Atorvastatin IR Pellets are pharmaceutical-grade immediate-release multiparticulate pellets containing Atorvastatin Calcium as the active ingredient. Atorvastatin Calcium has the anhydrous CAS Number 134523-03-8, molecular formula C₆₆H₆₈CaF₂N₄O₁₀, and molecular weight 1155.36 g/mol. The USP specification for Atorvastatin Calcium requires 98.0–102.0% on an anhydrous and solvent-free basis.
The immediate-release pellet format is designed to provide rapid availability of the active ingredient after administration. Atorvastatin can be incorporated into multiparticulate pellets using suitable pelletization technology, with the formulation controlling active loading, pellet size, mechanical properties, assay and dissolution characteristics.
Commercially documented Atorvastatin IR Pellets include 10% and 20% w/w strengths. Other commercial portfolios also report 7.5%, 15% and 20% strengths.
For the SDP website, 10% and 20% w/w are the commercially documented strengths most directly supported by the reviewed pellet portfolios. Publish them as SDP strengths only if they match the current SDP product specification or COA.
Atorvastatin IR Pellets are designed for immediate-release oral formulations requiring rapid release of the active ingredient.
The multiparticulate format is suitable for incorporation into capsule dosage forms according to the required strength and formulation specification.
Atorvastatin pellets provide a flexible intermediate for development of oral multiparticulate dosage forms.
The pellets can be used as a formulation intermediate for pharmaceutical manufacturers developing immediate-release products.
Atorvastatin IR Pellets can be supplied in bulk according to active loading, pellet-size distribution and approved quality specifications.
| 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% |
| Heavy Metals | NMT 20 ppm |
| Water Content | NMT 1.0% |