Description

Atorvastatin Lactam Lactone CAS NO 1795791-15-9 is a key pharmaceutical intermediate and impurity standard in the synthesis of atorvastatin calcium, the active ingredient in leading cholesterol-lowering medications. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by serving as a reference marker for process-related impurities. It is primarily required by pharmaceutical manufacturers, research institutions, and quality control laboratories engaged in the development, production, and regulatory compliance of statin-based therapies.

Application

• Primary reference standard for the identification and quantification of the lactam-lactone impurity in Atorvastatin Calcium API.
• Critical intermediate in the research, development, and optimization of synthetic pathways for atorvastatin.
• Essential component in analytical method development and validation for pharmaceutical quality control laboratories.
• Used in stability studies to monitor degradation products and ensure drug product shelf-life.
• Key material for regulatory submissions (e.g., ANDA, DMF) to demonstrate control over potential impurities.
• Valuable reagent in academic and industrial research exploring the structure-activity relationships of statin molecules.

Basic Information

Product Name	Atorvastatin Lactam Lactone
CAS No.	1795791-15-9
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 lactam 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 lactone; 1H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-, (βR,δR)-, γ-lactone
EINECS	Contact for details

Quality Control

Our Atorvastatin Lactam Lactone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity to stringent specifications. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot, supporting its use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled under controlled humidity conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%

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