Rosuvastatin calcium

Rosuvastatin calcium (CAS 147098-20-2), also known by the brand reference Crestor and as rosuvastatin hemicalcium, is a synthetic statin compound used as the active pharmaceutical ingredient (API) in cholesterol-lowering medications. It functions by inhibiting HMG-CoA reductase, making it the core ingredient in finished-dose cardiovascular drug products. The primary commercial application is the manufacture of oral solid dosage forms.

These include tablets and film-coated tablets targeting hypercholesterolemia and mixed dyslipidemia. Generic pharmaceutical manufacturers source this API to produce bioequivalent formulations following patent expiry of the originator product. Contract development and manufacturing organizations (CDMOs) also use it in early-phase and commercial-scale formulation development. Regulatory drug product filings across major markets require API sourced to documented standards.

These markets include FDA, EMA, and ICH-aligned jurisdictions. Rosuvastatin calcium is supplied as a white to off-white crystalline powder available in pharmaceutical-grade specifications aligned with USP and Ph. Eur. It is also available in EP and in-house monographs accepted by major regulatory agencies. Standard commercial supply includes defined particle size distributions to support manufacturing processes.

These processes include direct compression or wet granulation. The material is handled according to strict quality protocols to ensure stability and efficacy in the final pharmaceutical application.