Description

Rosuvastatin is a synthetic, selective, and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme in the cholesterol biosynthesis pathway. This high-purity active pharmaceutical ingredient (API) is essential for the formulation of effective lipid-lowering medications. It is primarily required by pharmaceutical manufacturers and research institutions developing treatments for hypercholesterolemia and dyslipidemia to reduce the risk of cardiovascular events.

Application

• Pharmaceutical API: Primary use as the active ingredient in finished dosage forms (e.g., tablets, capsules) for cholesterol management.
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent generic versions of rosuvastatin calcium medications.
• Clinical Research: Utilization in preclinical and clinical studies for new cardiovascular drug formulations and combination therapies.
• Reference Standard: Serves as a high-purity chemical reference standard for quality control and analytical method development in laboratories.
• Drug Intermediate: Used in the further chemical synthesis of rosuvastatin calcium or related derivative compounds.

Basic Information

Product Name	Rosuvastatin
CAS No.	1714147-49-5
Molecular Formula	C22H28FN3O6S
Molecular Weight	481.54 g/mol
Synonyms	Rosuvastatin Free Acid; (3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid; ZD-4522; S-4522; Crestor (API); Rosuvastatin (Acid Form)
EINECS	Contact for details

Quality Control

Our Rosuvastatin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. We provide Certificates of Analysis (COA) detailing specifications for identity, purity, and impurities, with testing performed via validated methods such as HPLC, NMR, and IR spectroscopy.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This compound is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.10%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤20 ppm
Loss on Drying	≤0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.