Description

Bosentan Impurity 5 is a specified impurity of the active pharmaceutical ingredient Bosentan, a dual endothelin receptor antagonist. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and quality control processes. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the synthesis, purification, and regulatory compliance of Bosentan-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Bosentan drug substance and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to ensure specificity, accuracy, and precision in impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial specifications.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug stability testing programs.
• Regulatory Submissions: Provides necessary data on impurity identity, structure, and toxicological qualification for regulatory filings (e.g., FDA, EMA) to support drug approval.
• Process Chemistry Research: Aids in understanding and optimizing the Bosentan synthesis pathway to minimize the formation of this impurity during manufacturing.

Basic Information

Product Name	Bosentan Impurity 5
CAS No.	1355251-10-3
Molecular Formula	C27H29N5O6S
Molecular Weight	551.61 g/mol
Synonyms	Bosentan Related Compound 5; 4-tert-Butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzenesulfonamide; Bosentan EP Impurity B; Bosentan USP Impurity 5; Bosentan Impurity B; 1355251-10-3; UNII-9G2B2VZ3KJ
EINECS	Contact for details

Quality Control

Our Bosentan Impurity 5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, LC-MS, NMR, and IR to confirm identity, purity, and structure. We provide full traceability and Certificates of Analysis (COA) that detail all test results against established specifications, ensuring compliance with ICH guidelines and supporting your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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