Description

(3S,5R,6E) Rosuvastatin Calcium Salt (2:1) is a high-purity, stereochemically defined active pharmaceutical ingredient (API) and a key intermediate in the synthesis of Rosuvastatin, a leading HMG-CoA reductase inhibitor. This specific (3S,5R,6E) isomer is critical for ensuring the desired pharmacological activity and meeting stringent regulatory requirements for finished drug products. It is essential for pharmaceutical manufacturers and advanced research facilities focused on developing and producing high-efficacy cholesterol-lowering medications.

Application

• Primary Pharmaceutical API Synthesis: As the definitive chiral building block for the industrial-scale production of Rosuvastatin calcium, the active ingredient in blockbuster statin drugs.
• Generic Drug Manufacturing: Serves as a core starting material for companies producing bioequivalent generic versions of Rosuvastatin, ensuring cost-effective supply.
• Process Research & Development (R&D): Used by chemists to develop and optimize novel, more efficient synthetic routes for Rosuvastatin and related compounds.
• Analytical Reference Standard: Employed in quality control laboratories as a high-purity standard for HPLC, LC-MS, and NMR methods to assay final drug products and intermediates.
• New Chemical Entity (NCE) Development: Acts as a precursor for medicinal chemists exploring new statin analogs or prodrugs with improved pharmacokinetic profiles.
• Regulatory Filings: Provides the necessary characterized intermediate for Drug Master File (DMF) submissions to agencies like the US FDA and EMA.

Basic Information

Item	Details
Product Name	(3S,5R,6E) Rosuvastatin Calcium Salt (2:1)
CAS No.	2414245-11-5
Molecular Formula	C44H54CaF2N6O12S2
Molecular Weight	1041.21 g/mol
Synonyms	Rosuvastatin Calcium (3S,5R,6E) Isomer; (3S,5R,6E)-Rosuvastatin Hemicalcium; (3S,5R,6E)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid Calcium Salt; Rosuvastatin EP Impurity C Calcium Salt; (E)-(3R,5S)-Rosuvastatin Calcium; ZD-4522 Calcium Salt (Isomer); Crestor® Intermediate (Isomer)
EINECS	Contact for details

Quality Control

Our (3S,5R,6E) Rosuvastatin Calcium Salt (2:1) is manufactured under strict quality systems. Each batch is tested to ensure compliance with high-purity pharmaceutical intermediate standards, with typical purity exceeding 98.5% by HPLC. Analytical methods include HPLC, chiral HPLC, 1H-NMR, and LC-MS for identity confirmation and impurity profiling. Certificates of Analysis (COA) detailing all specifications and 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). This compound is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere (e.g., nitrogen) after opening to prevent degradation. For long-term storage, consider desiccated conditions at 2-8°C.

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 (Chiral HPLC)	≥ 99.0% (3S,5R,6E) Isomer
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 2.0%
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.