Description

Rosuvastatin Isomer-11 is a specific stereoisomer of the widely used HMG-CoA reductase inhibitor, Rosuvastatin, identified by CAS NO 2162136-65-2. This high-purity intermediate is critical for pharmaceutical research and development, particularly in the synthesis and analytical characterization of active pharmaceutical ingredients (APIs). It serves as an essential reference standard for quality control laboratories and process development chemists working in the cardiovascular drug sector. The availability of this well-defined isomer is paramount for ensuring the stereochemical purity, efficacy, and safety profile of final drug products.

Application

• Pharmaceutical Reference Standard: Used as a critical comparator in HPLC, LC-MS, and NMR for the identification and quantification of Rosuvastatin and its related substances.
• Process Research & Development (R&D): Essential for studying metabolic pathways, degradation profiles, and for the development of stereoselective synthesis routes for Rosuvastatin API.
• Analytical Method Development: Serves as a key component in validating chromatographic methods to separate and analyze different Rosuvastatin isomers and impurities.
• Impurity Profiling: Employed to identify, characterize, and control isomeric impurities during the manufacturing of Rosuvastatin calcium, ensuring compliance with ICH guidelines.
• Metabolite Studies: Used in pharmacological and toxicological research to investigate the behavior and activity of specific Rosuvastatin stereoisomers.
• Regulatory Submissions: Provides necessary data and materials for drug master files (DMFs) and regulatory filings to demonstrate comprehensive impurity control.

Basic Information

Product Name	Rosuvastatin Isomer-11
CAS No.	2162136-65-2
Molecular Formula	C22H28FN3O6S
Molecular Weight	481.54 g/mol
Synonyms	(3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid Isomer-11; Rosuvastatin Related Compound; Rosuvastatin Impurity; (E)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethanesulfonamido)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid Isomer; ZD4522 Isomer-11
EINECS	Contact for details

Quality Control

Our Rosuvastatin Isomer-11 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral HPLC for isomeric purity and identity confirmation by spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic and spectral data are provided for traceability and regulatory compliance.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC, Area%)	≥ 98.0%
Isomeric Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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