Fluvastatin Sodium IR Pellets are pharmaceutical-grade immediate-release multiparticulate pellets containing Fluvastatin Sodium as the active pharmaceutical ingredient. They are designed for oral formulation applications where rapid release of the active ingredient from individual pellet units is required.
Fluvastatin Sodium is identified by CAS Number 93957-55-2, molecular formula C₂₄H₂₅FNNaO₄, and molecular weight 433.45 g/mol. The USP reference specifies Fluvastatin Sodium at 98.0%–102.0% on an anhydrous basis. This is an API specification and should not be directly applied as the finished Fluvastatin Sodium IR Pellets assay range.
Commercial pharmaceutical pellet portfolios document Fluvastatin Sodium IR Pellets at 15% w/w. This 15% strength is also listed alongside a 23% sustained-release format in commercial pellet portfolios. Therefore, 15% w/w is a documented commercial IR pellet strength; the strength displayed on the SDP website should correspond to the current SDP product specification or COA.
Fluvastatin Sodium is a sodium salt of Fluvastatin and has defined chemical and physical characteristics that are important during pharmaceutical formulation development. The immediate-release pellet format provides a multiparticulate platform in which active loading, pellet size, physical properties, active distribution and dissolution performance can be controlled according to the intended formulation.
Fluvastatin Sodium Immediate-Release Pellets are developed as multiple individual pellet units rather than a single-unit formulation. This multiparticulate structure provides flexibility in formulation development and downstream processing.
The performance of an immediate-release pellet system can be influenced by the pellet core composition, active loading, particle-size distribution, porosity, surface characteristics and manufacturing process. Excipients and pellet structure can also influence the rate at which Fluvastatin Sodium becomes available during dissolution.
Consistent pellet characteristics are important for pharmaceutical formulation because variations in pellet size, density, active distribution or mechanical integrity may affect processing and finished-product performance.
Fluvastatin Sodium 15% IR Pellets are a commercially documented immediate-release pellet format. Commercial pharmaceutical pellet portfolios specifically list Fluvastatin Sodium IR Pellets at 15% w/w.
For the SDP website:
Available Strength: 15% w/w
should be displayed when this strength is confirmed by the current SDP product specification.
The active loading represents the quantity of Fluvastatin Sodium incorporated into the finished pellet system. Active loading is an important parameter because it affects formulation composition, pellet mass, excipient ratio and downstream capsule-filling requirements.
The multiparticulate structure of Fluvastatin Sodium IR Pellets provides flexibility for oral formulation development. Each pellet acts as an individual unit, while the complete formulation contains a controlled population of pellets.
Fluvastatin Sodium IR Pellets can be considered for:
The final suitability depends on the intended formulation, manufacturing process and applicable finished-product specification.
Capsule filling is an important application for pharmaceutical multiparticulate pellets. Fluvastatin Sodium IR Pellets can be developed with appropriate particle-size distribution, density and physical characteristics to support capsule-filling operations.
Consistent pellet characteristics can help support reproducible filling and active distribution. Parameters such as particle size, bulk density, tapped density, friability, sphericity and pellet morphology may therefore be considered during product development.
The appropriate physical specifications should be established according to the intended formulation and finished-product requirements.
The release performance of Fluvastatin Sodium IR Pellets depends on the formulation and manufacturing design. Important variables can include:
An immediate-release pellet system should be evaluated using an appropriate validated dissolution method. The exact dissolution acceptance criteria are product-specific and should not be assumed to be identical across different pellet formulations.
Active loading is a key quality attribute for Fluvastatin Sodium IR Pellets. The intended concentration of Fluvastatin Sodium should remain consistent throughout the manufactured batch.
Content uniformity is important for multiparticulate formulations because consistent active distribution helps support reproducible finished-product performance. Appropriate process controls and analytical testing can be used to evaluate active distribution and batch consistency.
The API specification should always be distinguished from the finished-pellet specification. For example, the USP reference assay for Fluvastatin Sodium is 98.0%–102.0% on an anhydrous basis, whereas a 15% Fluvastatin Sodium pellet requires its own finished-product assay specification.
High-quality Fluvastatin Sodium Pharmaceutical Pellets can be evaluated through chemical, physical and performance-related characteristics.
Chemical evaluation may include:
Physical evaluation may include:
Performance evaluation may include:
The final acceptance criteria should be based on the applicable finished-product specification.
Fluvastatin Sodium IR Pellets provide a flexible multiparticulate platform for immediate-release formulation development. Formulation developers can evaluate active loading, pellet size, core composition and physical characteristics according to the intended formulation.
The pellet format can also support process optimization and scale-up by providing defined physical characteristics for downstream manufacturing operations.
For pharmaceutical manufacturers developing oral multiparticulate formulations, consistent pellet characteristics can support reproducible processing, capsule filling and finished-product quality.
Fluvastatin Sodium IR Pellets from Swapnroop are positioned as pharmaceutical-grade multiparticulate pellets for immediate-release formulation and bulk pharmaceutical applications.
Key product advantages include:
As a Fluvastatin Sodium IR Pellets Manufacturer and Supplier in India, Swapnroop can position Fluvastatin Sodium immediate-release pellets for pharmaceutical formulation development, multiparticulate applications, capsule filling and bulk pharmaceutical requirements, subject to the applicable product specification.
The product can be developed around relevant formulation parameters including active loading, pellet size, physical characteristics, active distribution and immediate-release dissolution performance.
Customers searching for Fluvastatin Sodium IR Pellets Manufacturer in India, Fluvastatin Sodium IR Pellets Supplier in India, Fluvastatin Sodium 15% IR Pellets, Fluvastatin Sodium Pharmaceutical Pellets, Fluvastatin Sodium Immediate-Release Pellets, Fluvastatin Sodium Multiparticulate Pellets, and Fluvastatin Sodium Pellets for Capsule Filling can be naturally addressed through the product page's topical content.
Fluvastatin Sodium IR Pellets can be supplied in suitable pharmaceutical packaging according to the required:
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Water Content | NMT 0.5% |