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Rosuvastatin calcium

CAS Number
147098-20-2
EC Number
627-028-1
Chemical Formula
C22H28FN3O6S.1/2Ca
Molecular Weight
1001.1 g/mol

Description

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. Contact us for supply of Rosuvastatin calcium Request Quote

Other Names (Synonyms)

ZD 4522 | Rosuvastatin hemicalcium | Crestor | Rosuvastatin Calcium Salt | Fortius | Rostar | Rozavel | Suvikan

Key Technical Features

  • High Purity Grade standard
  • Consistent Batch Quality
  • Full Regulatory & REACH Support
  • Global Logistics Network enabled

Physical Properties

Melting Point89.9 °C
AppearanceWhite to Off-White Crystalline Solid
Colorwhite to beige
Formpowder

Safety & Handling

Danger
GHS08· Health HazardGHS09· Environment

Hazard Statements

H350May cause cancer
H360May damage fertility or the unborn child
H370Causes damage to organs
H372Causes damage to organs through prolonged or repeated exposure
H410Very toxic to aquatic life with long lasting effects

Precautionary Statements

P203Obtain, consult and follow expert instructions for use.
P260Do not breathe dust/fume/gas/mist/vapours/spray.
P264Wash … thoroughly after handling.
P270Do not eat, drink or smoke when using this product.
P273Avoid release to the environment.
P280Wear protective gloves/protective clothing/eye protection/face protection.
P318IF exposed or concerned, get medical advice.
P319Get medical advice/attention if you feel unwell.
P321Specific treatment (see … on this label).
P391Collect spillage.
P405Store locked up.
P501Dispose of contents/container in accordance with local regulations.
P316Get emergency medical help immediately.

Trade & Regulatory

HS Code29350090
Storage Class11 - Combustible Solids
WGK (Germany)3