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.

Where is Rosuvastatin calcium used?

• Cardiovascular drug products: inhibits HMG-CoA reductase as core ingredient
• Oral solid dosage forms: tablets and film-coated tablets for hypercholesterolemia and mixed dyslipidemia
• Generic manufacturers produce bioequivalent formulations following patent expiry of the originator product
• CDMOs use it in early-phase and commercial-scale formulation development
• Regulatory drug product filings across major markets require API sourced to documented standards

Good to know: Regulatory markets include FDA, EMA, and ICH-aligned jurisdictions.

Commercial specifications

• Pharmaceutical-grade specifications aligned with USP, Ph. Eur., EP and in-house monographs accepted by major regulatory agencies
• Defined particle size distributions to support direct compression or wet granulation