Description

(3R,5R)-Rosuvastatin is a high-purity, stereochemically defined active pharmaceutical ingredient (API) and a key intermediate in the synthesis of Rosuvastatin calcium, a leading statin medication. This specific enantiomer is critical for ensuring the desired pharmacological activity and minimizing off-target effects in the final drug product. It is essential for pharmaceutical manufacturers and advanced research institutions engaged in the development and production of cardiovascular therapeutics, generic drugs, and novel chemical entities.

Application

• Primary Pharmaceutical Ingredient: Serves as a crucial chiral intermediate in the synthesis of Rosuvastatin calcium API.
• Generic Drug Manufacturing: Used by generic pharmaceutical companies for the production of bioequivalent Rosuvastatin formulations.
• Research & Development: Employed in pharmaceutical R&D for process optimization, analytical method development, and stability studies.
• Reference Standard: Acts as a high-purity chemical reference standard for quality control and regulatory compliance testing.
• New Drug Application (NDA): Supports the development of new dosage forms or combination therapies containing Rosuvastatin.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for cGMP production.

Basic Information

Product Name	(3R,5R)-Rosuvastatin
CAS No.	1094100-06-7
Molecular Formula	C22H28FN3O6S
Molecular Weight	481.54 g/mol
Synonyms	(3R,5R)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid; (3R,5R)-E-Rosuvastatin; (E)-(3R,5R)-Rosuvastatin; Rosuvastatin (3R,5R)-Isomer; (3R,5R)-Rosuvastatin Free Acid; ZD4522 (3R,5R)-Isomer
EINECS	Contact for details

Quality Control

Our (3R,5R)-Rosuvastatin is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including chiral purity verification by HPLC, to ensure it meets stringent specifications for pharmaceutical use. Certificates of Analysis (COA) detailing identity, purity, and impurity profiles are provided with every shipment. We support compliance with cGMP, ICH Q7, and other relevant pharmacopeial guidelines (USP/EP) as required.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

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%
Chiral Purity (HPLC)	≥99.0% (3R,5R)-Isomer
Related Substances (HPLC)	Total impurities ≤1.0% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.2%

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