Description

Atorvastatin Epoxy Tetrahydrofuran Impurity is a key process-related impurity and degradation product encountered during the synthesis and stability studies of Atorvastatin calcium, a leading statin medication. This compound is critical for pharmaceutical research and development, serving as a reference standard for method development, validation, and quality control to ensure drug purity and safety. It is primarily utilized by analytical laboratories, quality assurance departments, and regulatory affairs teams within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of this specific impurity in Atorvastatin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine batch release testing to ensure compliance with stringent pharmacopeial limits (e.g., ICH Q3A/B, USP, EP) for impurities.
• Stability Studies: Acts as a marker to study the degradation pathways and shelf-life of Atorvastatin under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic route of Atorvastatin to minimize the formation of this impurity.

Basic Information

Product Name	Atorvastatin Epoxy Tetrahydrofuran Impurity
CAS No.	873950-19-7
Molecular Formula	C33H35FN2O5
Molecular Weight	558.65 g/mol
Synonyms	(4R,6R)-6-{2-[(2S,4S)-4-(4-Fluorophenyl)-2-oxido-5-oxo-1,3,2λ5-dioxaphosphinan-2-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl acetate; Atorvastatin Epoxide Impurity; Atorvastatin EP Impurity F; Atorvastatin Related Compound F; Atorvastatin 2,3-Epoxide; (βR,δR)-2-(4-Fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic Acid Epoxide Derivative
EINECS	Contact for details

Quality Control

Our Atorvastatin Epoxy Tetrahydrofuran Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP 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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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