Description

Atorvastatin is a synthetic lipid-lowering agent belonging to the statin class of drugs, widely recognized for its potent inhibition of HMG-CoA reductase. This active pharmaceutical ingredient (API) is the critical component in formulations designed to manage hypercholesterolemia and reduce the risk of cardiovascular events. It is essential for pharmaceutical manufacturers and R&D institutions developing generic and branded cholesterol-lowering medications.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral solid dosage forms (tablets, capsules) for lowering LDL cholesterol and triglycerides.
• Generic Drug Manufacturing: Serves as the core component for the production of bioequivalent generic versions of lipid-regulating therapies.
• Cardiovascular Research: Used in preclinical and clinical research studies investigating atherosclerosis, lipid metabolism, and cardiovascular disease pathways.
• Combination Therapies: Employed in the development of fixed-dose combination drugs that include atorvastatin with other cardiovascular agents.
• Reference Standard: High-purity grades are utilized as analytical reference standards in quality control laboratories for HPLC and spectroscopic assays.

Basic Information

Product Name	Atorvastatin
CAS No.	134523-00-5
Molecular Formula	C33H35FN2O5
Molecular Weight	558.64 g/mol
Synonyms	Atorvastatin Calcium; Atorvastatin Hemicalcium; Lipitor (Brand Name); CI-981; (βR,δR)-2-(4-Fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic Acid; SQ 33,600; Atorvastatin Free Acid
EINECS	Contact for details

Quality Control

Our Atorvastatin is manufactured under strict quality management systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical applications, with specifications aligning with major pharmacopoeial guidelines. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with every shipment to ensure full traceability and regulatory compliance.

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.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Total impurities ≤ 1.0%; Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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