Description

Atorvastatin Oxirane Impurity is a key process-related impurity and a critical intermediate in the synthesis of the widely prescribed cholesterol-lowering drug, Atorvastatin. Its precise identification and quantification are essential for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API). This high-purity reference standard is primarily required by pharmaceutical manufacturers and analytical laboratories for research, method development, and stringent quality control processes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the oxirane impurity in Atorvastatin API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor and control impurity profiles during API manufacturing.
• Process Chemistry Research: Serves as a key intermediate for studying and optimizing the synthetic pathway of Atorvastatin to minimize impurity formation.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies (ICH Q3A/B).
• Quality Control & Batch Release Testing: Employed in routine QC labs to ensure that Atorvastatin batches meet strict pharmacopeial (USP, EP) specifications for related substances.
• Stability Studies: Used to track the formation of degradation products in stability samples of Atorvastatin under various stress conditions.

Basic Information

Product Name	Atorvastatin Oxirane Impurity
CAS No.	1246818-88-1
Molecular Formula	C33H35FN2O5
Molecular Weight	558.65 g/mol
Synonyms	(4R,6R)-6-{2-[(2R,4R)-4-(4-Fluorophenyl)-5-(1-methylethyl)-2-phenyl-1,3-dioxolan-2-yl]ethyl}-2,2-dimethyl-1,3-dioxane-4-acetic Acid 1,2-Epoxide; Atorvastatin Epoxide Impurity; Atorvastatin Oxirane; Atorvastatin Related Compound Oxirane; (4R-cis)-6-[2-[4-(4-Fluorophenyl)-5-(1-methylethyl)-2-phenyl-1,3-dioxolan-2-yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-acetic Acid, 1,2-Epoxide
EINECS	Contact for details

Quality Control

Our Atorvastatin Oxirane Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting compliance with ICH and cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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