Description

Atorvastatin Dehydro Lactone is a key pharmaceutical intermediate and impurity reference standard used in the synthesis and quality control of atorvastatin, a leading statin medication. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API). It is primarily utilized by research institutions, analytical laboratories, and manufacturers within the global pharmaceutical and fine chemical industries for process development, validation, and regulatory compliance.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthetic pathway for Atorvastatin Calcium (API).
• Reference Standard: Used as an impurity standard in HPLC and other chromatographic methods to monitor and control the quality of atorvastatin API and formulations.
• Process Research & Development (R&D): Employed in route scouting, optimization, and scale-up studies for atorvastatin manufacturing.
• Analytical Method Development: Serves as a critical component for developing and validating stability-indicating assay methods.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require characterization and quantification of process-related impurities.
• Academic & Contract Research: Used in pharmacological and metabolic studies related to statin drugs.

Basic Information

Product Name	Atorvastatin Dehydro Lactone
CAS No.	442851-50-5
Molecular Formula	C33H33FN2O4
Molecular Weight	540.63 g/mol
Synonyms	(3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid δ-lactone; Atorvastatin Lactone Impurity; Atorvastatin EP Impurity F; Atorvastatin Related Compound F; (βR,δR)-2-(4-Fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid δ-lactone
EINECS	Contact for details

Quality Control

Our Atorvastatin Dehydro Lactone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets stringent specifications for use as a reference standard and intermediate. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.