Description

Rac-Atorvastatin Calcium CAS NO 363599-71-7 is a key pharmaceutical intermediate and reference standard, representing the racemic form of the widely used cholesterol-lowering agent. This compound is essential for research and development, enabling the study of stereochemistry, metabolic pathways, and impurity profiling critical for drug safety and efficacy. It serves as a vital raw material for analytical laboratories, academic researchers, and manufacturers involved in the synthesis and quality control of statin-based active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used for analytical method development, validation, and calibration in HPLC, LC-MS, and other chromatographic systems to ensure accurate quantification of Atorvastatin and its isomers.
• Research & Development: Critical for preclinical and clinical studies investigating the pharmacokinetics, pharmacodynamics, and metabolic fate of statin molecules.
• Impurity Profiling: Serves as a known impurity or starting material control sample in the quality assurance of enantiomerically pure Atorvastatin Calcium API batches.
• Process Chemistry: Utilized in the development and optimization of synthetic routes for statin production, including chiral separation and resolution studies.
• Academic Research: Employed in universities and research institutes for biochemical studies on HMG-CoA reductase inhibition and related cardiovascular research.
• Regulatory Compliance: Acts as a critical component in stability studies and regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate thorough understanding of the drug substance.

Basic Information

Product Name	Rac-Atorvastatin Calcium
CAS No.	363599-71-7
Molecular Formula	C66H68CaF2N4O10
Molecular Weight	1155.36 g/mol
Synonyms	Atorvastatin Calcium Racemate; (±)-Atorvastatin Calcium Salt; Calcium (3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (racemic); CI-981 (Racemic); Lipitor Impurity (Racemate); (R*,R*)-Atorvastatin Calcium; UNII-48A5M73Z4Q (Racemate)
EINECS	Contact for details

Quality Control

Our Rac-Atorvastatin Calcium is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral purity determination, to ensure it meets the high standards required for research and pharmaceutical applications. Certificates of Analysis (COA) are provided, detailing results for identity, assay, chiral purity, and related substances. We support compliance with ICH guidelines and can supply material suitable for use as a reference standard.

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Chiral Purity (HPLC)	Racemic mixture (approx. 50:50 ratio of enantiomers)
Related Substances (HPLC)	Total impurities ≤ 2.0%
Any single unknown impurity	≤ 0.5%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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