Description

Atorvastatin Pyrrolidone Lactone is a key pharmaceutical intermediate in the synthesis of the widely prescribed cholesterol-lowering drug, Atorvastatin Calcium. This compound is critical for ensuring the structural integrity and efficacy of the final active pharmaceutical ingredient (API). It is primarily utilized by manufacturers in the pharmaceutical and fine chemical industries engaged in the production of cardiovascular medications.

Application

• Primary Intermediate for the synthesis of Atorvastatin Calcium API.
• Research & Development of new statin-based therapeutic agents and analogs.
• Process Chemistry for optimizing manufacturing routes and scaling up production.
• Quality Control and analytical reference standard in pharmaceutical laboratories.
• Generic Drug Manufacturing for producing cost-effective versions of lipid-regulating drugs.

Basic Information

Product Name	Atorvastatin Pyrrolidone Lactone
CAS No.	906552-19-0
Molecular Formula	C33H34FN3O5
Molecular Weight	571.64 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; Atorvastatin EP Impurity C; Atorvastatin USP Related Compound C; (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 Pyrrolidone Lactone is manufactured under strict quality management systems to meet the rigorous standards of the pharmaceutical industry. Each batch is tested against comprehensive specifications using advanced analytical techniques such as HPLC, NMR, and MS to ensure identity, purity, and consistency. Certificates of Analysis (COA) are provided and can be tailored to meet specific pharmacopeial requirements (e.g., USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The material is moisture-sensitive; ensure the container is kept sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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