Description

(3S,5S)-Atorvastatin Sodium Salt is a high-purity, stereochemically defined active pharmaceutical ingredient (API) and key intermediate. This compound is critical for the research and development of advanced statin-based therapeutics targeting cholesterol management. It is essential for pharmaceutical manufacturers, R&D laboratories, and analytical reference standard producers focused on cardiovascular disease treatment.

Application

• Pharmaceutical API Synthesis: A key chiral intermediate in the production of high-purity Atorvastatin and its related drug substances.
• Reference Standard: Used as a certified reference material (CRM) for quality control, method validation, and regulatory submissions in pharmaceutical analysis.
• Process Chemistry R&D: Serves as a critical building block for exploring novel synthetic routes and process optimization in statin manufacturing.
• Metabolite Studies: Employed in pharmacokinetic and metabolic pathway research for statin drugs.
• Formulation Development: Used in pre-formulation studies for developing stable and bioavailable dosage forms.
• Impurity Profiling: Acts as a marker or precursor for identifying and quantifying related substances and degradation products.

Basic Information

Product Name	(3S,5S)-Atorvastatin Sodium Salt
CAS No.	501121-34-2
Molecular Formula	C33H34FN2NaO5
Molecular Weight	580.63 g/mol
Synonyms	(3S,5S)-Atorvastatin Sodium; Sodium (3S,5S)-Atorvastatin; Atorvastatin (3S,5S) Sodium Salt; (3R,5R)-Atorvastatin Sodium Salt (enantiomer); [R-(R*,R*)]-2-(4-Fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid sodium salt; Lipitor Intermediate; Atorvastatin EP Impurity G Sodium Salt
EINECS	Contact for details

Quality Control

Our (3S,5S)-Atorvastatin Sodium Salt is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including chiral purity verification, to ensure it meets stringent specifications for pharmaceutical use. Certificates of Analysis (COA) with detailed chromatographic data (HPLC, chiral HPLC) are provided, supporting compliance with ICH Q7, GMP, and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment. For long-term storage, consider inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Chiral Purity (Chiral HPLC)	≥99.0% (3S,5S) isomer
Water Content (KF)	≤5.0%
Residue on Ignition	≤0.5%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Total impurities ≤2.0%
Individual Unknown Impurity	≤0.5%

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