Description

Atorvastatin Sodium CAS NO 134523-01-6 is the sodium salt form of atorvastatin, a synthetic lipid-lowering agent. This high-purity active pharmaceutical ingredient (API) is the critical component in the production of cholesterol-lowering medications. It is essential for pharmaceutical manufacturers developing and producing generic and branded formulations of statin-based therapies. The compound's efficacy in inhibiting HMG-CoA reductase makes it a cornerstone in cardiovascular disease management.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of generic and branded atorvastatin calcium tablets and capsules for hyperlipidemia treatment.
• Cardiovascular Drug Formulations: Used in solid oral dosage forms (tablets) and other delivery systems aimed at reducing LDL cholesterol and triglyceride levels.
• Research & Development: Serves as a key reference standard and starting material in pharmaceutical R&D for new cardiovascular drug combinations and delivery mechanisms.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of finished dosage forms under cGMP guidelines.
• Regulatory Submissions: Used to generate batches for stability studies, bioequivalence testing, and regulatory filing dossiers (e.g., ANDA, DMF).

Basic Information

Product Name	Atorvastatin Sodium
CAS No.	134523-01-6
Molecular Formula	C33H34FN2NaO5
Molecular Weight	580.62 g/mol
Synonyms	Atorvastatin Sodium Salt; Atorvastatin Na; (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid sodium salt; Lipitor Sodium Salt; CI-981 Sodium; SQ-330 Sodium; Atorvastatin Sodium API
EINECS	Contact for details

Quality Control

Our Atorvastatin Sodium is manufactured under strict quality management systems in compliance with cGMP guidelines. Each batch undergoes comprehensive analytical testing, including HPLC for purity and related substances, identification by IR and NMR, and residual solvent analysis. We provide full traceability and support regulatory filings with comprehensive documentation. Certificates of Analysis (COA) are available upon request, detailing compliance with in-house specifications aligned with major pharmacopoeial standards.

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 must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Maximum Impurity	≤ 0.5%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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