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 critical 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 active ingredient in cholesterol-lowering tablet formulations (e.g., Crestor® equivalents).
• Generic Drug Manufacturing: Core component for producing bioequivalent generic rosuvastatin calcium medications.
• Clinical Research: Used in preclinical and clinical studies for cardiovascular disease therapeutics.
• Dosage Form Development: Employed in R&D for developing fixed-dose combination drugs and novel delivery systems.
• Reference Standard: Serves as an analytical standard for quality control and regulatory testing in laboratories.
• Biochemical Research: Tool compound for studying the mevalonate pathway and sterol biosynthesis in cellular models.

Basic Information

Product Name	Rosuvastatin
CAS No.	287714-41-4
Molecular Formula	C22H28FN3O6S
Molecular Weight	481.54 g/mol
Synonyms	Rosuvastatin Calcium; ZD-4522; S-4522; Crestor; (3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic Acid; Rosuvastatin Free Acid
EINECS	Contact for details

Quality Control

Our Rosuvastatin is manufactured under strict quality management systems. It is tested to meet stringent specifications for identity, purity, and potency, aligning with major pharmacopoeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological limits is provided with each batch to ensure traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.2%
Microbiological Enumeration	Complies with EP/USP criteria

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