Description

Fluvastatin Sodium

Fluvastatin Sodium is a synthetic statin active pharmaceutical ingredient used in regulated pharmaceutical development and manufacturing programs where material identity, purity, stereochemical control, documentation readiness, and dependable sourcing are essential. It has the molecular formula C₂₄H₂₅FNNaO₄, a molecular weight of approximately 433.4 g/mol, and CAS Registry Number 93957-55-2. Fluvastatin Sodium is
• A synthetic statin active pharmaceutical ingredient
• The Sodium salt of Fluvastatin
• Applicable to immediate-release capsules and extended-release tablet development
• Suitable for analytical evaluation, formulation development, scale-up, validation, and qualified commercial manufacturing
• Requires control of identity, assay, stereochemistry, related substances, water content, and residual solvents
• Supported by technical documentation for supplier qualification and quality review
Fluvastatin Sodium is the Sodium salt of Fluvastatin, a fully synthetic inhibitor of 3-Hydroxy-3-methylglutaryl-coenzyme A reductase, commonly abbreviated as HMG-CoA reductase. Reference information describes the material as a white to pale-yellow, hygroscopic powder that is soluble in water, ethanol, and methanol. These physical characteristics should be considered during sampling, weighing, storage, blending, granulation, compression, encapsulation, and analytical method development.
The active ingredient is used in oral pharmaceutical products, including immediate-release capsules and extended-release tablets. Current United States labeling includes Fluvastatin capsules in 20 mg and 40 mg strengths, while historical branded labeling also describes an 80 mg extended-release tablet. The suitability of a particular Fluvastatin Sodium grade for either dosage form depends on its material specification, particle characteristics, manufacturing process, excipient system, release profile, and destination-market requirements.
Formulation teams developing immediate-release capsules may evaluate particle-size distribution, bulk density, flow, blend uniformity, dissolution behavior, hygroscopicity, and compatibility with capsule excipients. Extended-release tablet programs may additionally require careful assessment of polymer compatibility, compression behavior, release-controlling matrices, moisture sensitivity, and dissolution performance across the intended shelf life. Product-specific studies are necessary to determine whether the selected material meets the required processing and finished-dosage-form performance criteria.
For companies looking to buy Fluvastatin Sodium, supplier qualification should extend beyond price and immediate availability. A qualified Fluvastatin Sodium supplier should provide an unambiguous chemical identity, current material specification, traceable batch information, assay data, related-substance testing, water-content limits, residual-solvent information, and appropriate storage guidance. Because the compound contains defined stereochemistry, customers should also review the controls used to confirm the required stereochemical form and limit unwanted isomers.
CarboMer approaches Fluvastatin Sodium sourcing with a regulation-first and manufacturing-centered perspective. Research and development teams benefit from a supplier capable of supporting material evaluation, excipient compatibility studies, analytical method development, dissolution testing, stability planning, and scale-up. Quality and regulatory professionals require complete lot documentation, clearly defined acceptance criteria, and dependable change communication. Procurement teams need confidence that the selected material can be purchased consistently as demand progresses from laboratory quantities to validation and commercial production.
When customers purchase Fluvastatin Sodium for pharmaceutical use, the current product specification and Certificate of Analysis should be reviewed against the proposed dosage form and regulatory strategy. Relevant parameters may include identification, assay, related substances, stereochemical purity, water content, residual solvents, elemental impurities, particle-size distribution, bulk properties, microbial requirements, appearance, storage conditions, and retest period. The chemical name alone does not establish suitability for a specific capsule, tablet, modified-release product, or market.
The material is supported by standard technical documentation, including a Certificate of Analysis, Safety Data Sheet, and related product information where applicable. Available analytical methods, impurity controls, residual-solvent limits, elemental-impurity information, particle specifications, storage requirements, and regulatory support should be confirmed for the individual grade before ordering. Batch-to-batch consistency, traceability, and controlled handling remain central to reliable pharmaceutical sourcing.
Fluvastatin Sodium should be handled by trained personnel using appropriate pharmaceutical or laboratory controls. Because the material is hygroscopic, unnecessary exposure to atmospheric moisture should be minimized. Personnel should review the current Safety Data Sheet and follow site-specific procedures for receiving, sampling, weighing, transferring, processing, storage, and disposal.
The material is packaged in appropriate containers selected to protect its quality from moisture, light, contamination, and environmental exposure during storage and transportation. Packaging formats, minimum order quantities, availability, and lead times may be discussed according to analytical, development, validation, and commercial purchasing requirements.
As with all CarboMer products, customers receive responsive technical communication and documentation support intended to advance material qualification, formulation development, analytical evaluation, scale-up, and long-term supply planning.