Description

Rosuvastatin 3S, 5S-Isomer is a high-purity, stereochemically defined intermediate critical for the synthesis of the blockbuster cholesterol-lowering drug, Rosuvastatin calcium. This specific isomer is essential for ensuring the correct biological activity and efficacy of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers and advanced research organizations engaged in the development and production of high-quality statin medications.

Application

• Pharmaceutical Intermediate: Key chiral building block in the synthesis of Rosuvastatin calcium API.
• Active Pharmaceutical Ingredient (API) Development: Used in R&D for process optimization and new formulation studies of statin drugs.
• Reference Standard: Serves as a critical analytical standard for quality control and regulatory compliance testing.
• Process Chemistry: Employed in scaling up and validating robust, GMP-compliant manufacturing processes.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for commercial API production.
• Academic & Biomedical Research: Used in studies investigating the structure-activity relationships of HMG-CoA reductase inhibitors.

Basic Information

Product Name	Rosuvastatin 3S, 5S-Isomer
CAS No.	1584149-34-7
Molecular Formula	C₂₂H₂₈FN₃O₆S
Molecular Weight	481.54 g/mol
Synonyms	(3S,5S)-Rosuvastatin; (3S,5S)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid; Rosuvastatin (3S,5S) Isomer; Rosuvastatin Stereoisomer; ZD4522 (3S,5S)-Isomer; Crestor® Intermediate
EINECS	Contact for details

Quality Control

Our Rosuvastatin 3S, 5S-Isomer is manufactured under strict quality systems to meet the exacting standards of the pharmaceutical industry. Each batch is subjected to comprehensive analytical testing, including chiral purity assay and impurity profiling via HPLC, to ensure identity, strength, quality, and purity. Certificates of Analysis (COA) detailing all specifications are provided and can be tailored to support regulatory filings (e.g., DMF, CMC sections).

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 material is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or in a desiccated environment after opening to maintain stability and prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Chiral Purity (Chiral HPLC)	≥ 99.0% (3S,5S-Isomer)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5%

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