Description

Atorvastatin Cyclic Sodium Salt (Isopropyl) Impurity is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the identification, quantification, and control of a specific process-related impurity during the synthesis of Atorvastatin, a leading cholesterol-lowering drug. It is primarily used by analytical laboratories and quality control units within pharmaceutical companies and contract research organizations (CROs) to ensure drug safety and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the accurate identification and quantification of the (Isopropyl) cyclic sodium salt impurity in Atorvastatin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Batch Release: Employed in routine quality control testing to monitor impurity levels, ensuring every batch of Atorvastatin API meets stringent internal and pharmacopoeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation or increase of this specific impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the impurity profile.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway to minimize the formation of this impurity, improving overall yield and purity.

Basic Information

Product Name	Atorvastatin Cyclic Sodium Salt (Isopropyl) Impurity
CAS No.	1316291-19-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3R,5R)-7-[2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid Cyclic Sodium Salt; Atorvastatin Isopropyl Impurity Sodium Salt; Atorvastatin Related Compound; Atorvastatin Cyclic Sodium Ester Impurity; Atorvastatin EP Impurity G (Isopropyl Analog); Atorvastatin Process Impurity
EINECS	Contact for details

Quality Control

Our Atorvastatin Cyclic Sodium Salt (Isopropyl) Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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