Description

Ataluren Impurity J is a specified impurity and degradation product of the pharmaceutical compound Ataluren. This compound is critical for analytical reference standards in pharmaceutical research and development, ensuring the quality, safety, and efficacy of the final drug product. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Ataluren Impurity J in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Essential for developing and validating sensitive analytical methods, such as HPLC and LC-MS, to monitor impurity profiles.
• Quality Control (QC) Testing: Used in routine QC laboratories to ensure Ataluren batches comply with stringent regulatory limits for specified impurities.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug substance impurity profile.
• Process Chemistry Research: Aids chemists in understanding degradation pathways and optimizing synthesis and purification processes to minimize impurity formation.

Basic Information

Product Name	Ataluren Impurity J
CAS No.	1141475-82-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	3-[5-(2-Fluorophenyl)-1,2,4-oxadiazol-3-yl]benzoic acid Impurity J; PTC124 Impurity J; Translarna Impurity J; Ataluren Related Compound J; 3-(5-(2-Fluorophenyl)-1,2,4-oxadiazol-3-yl)benzoic acid impurity
EINECS	Contact for details

Quality Control

Every batch of Ataluren Impurity J is manufactured and handled under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 must be kept under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%

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