Description

Ataluren Impurity B CAS NO 775304-80-8 is a specified impurity of Ataluren, a pharmaceutical compound used in the treatment of certain genetic disorders. This impurity is critical for analytical method development, stability studies, and ensuring the quality and safety of the final drug substance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, quality control, and compliance purposes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ataluren Impurity B in drug substance and drug product batches.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Ataluren and establish appropriate shelf-life.
• Quality Control & Release Testing: A critical component in the quality control laboratory for routine batch analysis to ensure impurity levels are within ICH/USP/EP specified limits.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research & Development: Used in R&D to study the synthesis, formation, and chemical behavior of this specific impurity.

Basic Information

Product Name	Ataluren Impurity B
CAS No.	775304-80-8
Molecular Formula	C15H9F3N4O4
Molecular Weight	366.25 g/mol
Synonyms	3-[5-(2-Fluorophenyl)-1,2,4-oxadiazol-3-yl]benzoic acid; Ataluren Related Compound B; PTC124 Impurity B; Translarna Impurity B; 2-Fluoro-5-[3-(3-carboxyphenyl)-1,2,4-oxadiazol-5-yl]benzoic acid (Regioisomer); UNII-9F8S6A3D4C; Benzoic acid, 3-[5-(2-fluorophenyl)-1,2,4-oxadiazol-3-yl]-
EINECS	Contact for details

Quality Control

Our Ataluren Impurity B is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical impurity analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and chromatographic profiles.

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) and must be kept in a desiccated environment to maintain stability and purity. Avoid prolonged exposure to air and humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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