Description

Rosuvastatin Calcium CAS NO 147098-20-2 is the active pharmaceutical ingredient (API) of the widely prescribed cholesterol-lowering medication. This compound is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme in cholesterol biosynthesis. It is essential for the formulation of finished dosage forms, primarily tablets, used in the treatment of hypercholesterolemia and dyslipidemia to reduce the risk of cardiovascular events.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of finished solid dosage forms (e.g., tablets, capsules) for cholesterol management.
• Generic Drug Formulation: Critical raw material for the production of generic rosuvastatin calcium tablets following patent expirations in various markets.
• Cardiovascular Therapeutics: Formulated into medications prescribed to lower LDL ("bad") cholesterol and triglycerides while raising HDL ("good") cholesterol.
• Clinical Research: Used as a reference standard or active component in bioequivalence studies and new drug development research.
• Contract Manufacturing: Supplied to pharmaceutical contract development and manufacturing organizations (CDMOs) for production.

Basic Information

Product Name	Rosuvastatin Calcium
CAS No.	147098-20-2
Molecular Formula	C44H54CaF2N6O12S2
Molecular Weight	1001.14 g/mol
Synonyms	Rosuvastatin Calcium; (3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic Acid Calcium Salt (2:1); ZD-4522 Calcium; Crestor® (Brand Name); Rosuvastatin Calcium Salt; Bis[(3R,5S,6E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[N-methyl-N-(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid] Calcium
EINECS	Contact for details

Quality Control

Our Rosuvastatin Calcium is manufactured under strict quality management systems. It is produced to meet the exacting standards required for pharmaceutical active ingredients, with specifications typically aligned with major pharmacopoeias such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia). Every batch undergoes rigorous analytical testing including assay, impurity profiling, and residual solvent analysis. Certificates of Analysis (COA) are provided to ensure full traceability and compliance with your quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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