Description

Rosuvastatin Sodium is the active pharmaceutical ingredient (API) of the widely prescribed statin medication, Rosuvastatin. This high-purity compound is critical for the formulation of cholesterol-lowering drugs that help manage hyperlipidemia and reduce cardiovascular risk. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of solid oral dosage forms, such as tablets and capsules.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of Rosuvastatin calcium tablets and other dosage forms for treating high cholesterol and related conditions.
• Generic Drug Production: Serves as the key raw material for formulating generic versions of branded statin medications.
• Research & Development: Used in preclinical and clinical studies for investigating new therapeutic applications, formulations, or delivery systems for statins.
• Reference Standard: Employed as an analytical standard in quality control laboratories for HPLC, UV, and other spectroscopic methods to ensure product identity and purity.
• Biochemical Research: Utilized in studies focusing on HMG-CoA reductase inhibition, lipid metabolism, and atherosclerosis pathways.

Basic Information

Product Name	Rosuvastatin Sodium
CAS No.	147098-18-8
Molecular Formula	C22H27FN3NaO6S
Molecular Weight	503.52 g/mol
Synonyms	Rosuvastatin Sodium Salt; (3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic Acid Sodium Salt; ZD-4522 Sodium; Crestor API (Sodium Form); S-4522/1; Bis(rosuvastatin) sodium
EINECS	Contact for details

Quality Control

Our Rosuvastatin Sodium is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profiling via HPLC, to ensure it meets high-purity standards suitable for pharmaceutical use. Certificates of Analysis (COA) detailing all test results are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption.

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 single impurity ≤ 0.5%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.2%
Heavy Metals	≤ 20 ppm

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