Description

Atorvastatin Diepoxide Calcium Salt is a key pharmaceutical intermediate and impurity reference standard in the synthesis and quality control of atorvastatin, a leading cholesterol-lowering medication. This high-purity compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in process development, impurity profiling, and stability studies of statin-based therapies.

Application

• Pharmaceutical Intermediate: Used in the synthesis and purification of Atorvastatin Calcium API.
• Analytical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in quality control laboratories.
• Process Research & Development (R&D): Essential for studying degradation pathways, optimizing synthesis routes, and validating manufacturing processes.
• Regulatory Compliance & Filing: Provides necessary impurity data for regulatory submissions (e.g., FDA, EMA) to meet ICH guidelines.
• Stability Studies: Used to identify and quantify degradation products in forced degradation and long-term stability testing of drug substances and products.
• Method Development & Validation: A critical component for developing and validating analytical methods for impurity detection and quantification.

Basic Information

Product Name	Atorvastatin Diepoxide Calcium Salt
CAS No.	887470-43-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atorvastatin Epoxide Impurity Calcium Salt; Atorvastatin Dioxirane Calcium Salt; (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid Calcium Salt Diepoxide; Atorvastatin Degradation Product; Atorvastatin Impurity E (Calcium Salt); Atorvastatin Related Compound E
EINECS	Contact for details

Quality Control

Our Atorvastatin Diepoxide Calcium Salt 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 the stringent requirements for pharmaceutical reference standards and intermediates. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. We support compliance with ICH Q3A, Q3B, and Q6A guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	Contact for details

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