Description

Atorvastatin 10-Trans (Atorvastatin Impurity At10) is a specified stereoisomeric impurity critical for the quality control and regulatory compliance of Atorvastatin Active Pharmaceutical Ingredients (APIs) and finished drug products. This compound is essential for pharmaceutical manufacturers and analytical laboratories to develop, validate, and perform accurate impurity profiling and stability studies. It is primarily used by pharmaceutical R&D teams, quality control (QC) analysts, and regulatory affairs specialists to ensure product safety, efficacy, and adherence to stringent pharmacopeial standards like USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of the 10-trans isomer impurity in Atorvastatin calcium.
• Method Development and Validation: Used in analytical laboratories to develop and validate HPLC, UPLC, or LC-MS methods for impurity detection as per ICH Q2(R1) and Q3B(R2) guidelines.
• Stability Testing and Forced Degradation Studies: Employed to monitor impurity levels in stability samples to establish shelf-life and understand degradation pathways.
• Quality Control and Batch Release: Critical for in-house QC testing to ensure every batch of Atorvastatin API meets the specified impurity limits before release.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate thorough impurity control.
• Pharmacopeial Testing: Used to perform tests as per United States Pharmacopeia (USP) or European Pharmacopoeia (EP) monographs for Atorvastatin.

Basic Information

Product Name	Atorvastatin 10-Trans (Atorvastatin Impurity At10)
CAS No.	131275-93-9
Molecular Formula	C33H35FN2O5
Molecular Weight	558.65 g/mol
Synonyms	(3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid (10-trans Isomer); Atorvastatin EP Impurity J; Atorvastatin USP Impurity J; Atorvastatin Related Compound J; (10-trans)-Atorvastatin; Atorvastatin 10-trans Isomer; Atorvastatin Impurity J (10-trans); AT10 Impurity
EINECS	Contact for details

Quality Control

Our Atorvastatin 10-Trans impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from orthogonal methods like HPLC, LC-MS, and NMR. Our quality commitment aligns with ICH guidelines and supports compliance with current Good Manufacturing Practices (cGMP).

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 product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Assay (on dried basis)	97.0% - 102.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C Class 2 & 3 limits
Loss on Drying	≤ 0.5%

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