Description

(3S,5R)-Atorvastatin CAS NO 887324-52-9 is a high-purity, single-enantiomer pharmaceutical intermediate, representing a critical isomer in the synthesis of the widely prescribed cholesterol-lowering drug atorvastatin. Its precise stereochemistry is essential for ensuring the efficacy and safety of the final active pharmaceutical ingredient (API). This compound is a vital building block for pharmaceutical manufacturers and advanced research institutions focused on cardiovascular therapeutics and chiral synthesis development.

Application

• Pharmaceutical Intermediate: Primary use as a key chiral synthon in the commercial synthesis of Atorvastatin Calcium (API).
• Active Pharmaceutical Ingredient (API) Research: Serves as a critical precursor in R&D for developing and optimizing atorvastatin manufacturing processes.
• Chiral Reference Standard: Used as a high-purity standard in analytical laboratories for method development, validation, and quality control of atorvastatin-based products.
• Metabolite Studies: Employed in pharmacological and pharmacokinetic research to study the metabolism and biological activity of atorvastatin isomers.
• Process Chemistry Development: Utilized for scaling up and troubleshooting stereoselective synthesis routes in process chemistry.
• Regulatory Submissions: Provides essential material for generating impurity profiles and stability data required for drug master files (DMFs) and regulatory filings.

Basic Information

Product Name	(3S,5R)-Atorvastatin
CAS No.	887324-52-9
Molecular Formula	C33H35FN2O5
Molecular Weight	558.65 g/mol
Synonyms	(3S,5R)-Atorvastatin; (3R,5S)-Atorvastatin (enantiomer); Atorvastatin (3S,5R)-isomer; (βR,δS)-Atorvastatin; (3S,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid; Lipitor Intermediate; CI-981 Isomer
EINECS	Contact for details

Quality Control

Our (3S,5R)-Atorvastatin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral purity verification by HPLC, to ensure it meets stringent specifications for pharmaceutical intermediate use. A Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with every shipment. Production can be aligned with cGMP guidelines for advanced applications.

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 conditions (e.g., nitrogen atmosphere) after opening to prevent degradation. Keep away from incompatible materials.

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%
Chiral Purity (HPLC)	≥99.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.