Description

Bosentan Impurity CAS NO 1268612-25-4 is a high-purity chemical reference standard used in the pharmaceutical development and manufacturing process. This compound is critical for the quality control and regulatory compliance of Bosentan, an endothelin receptor antagonist medication. It is primarily required by analytical laboratories and pharmaceutical companies engaged in research, method development, and impurity profiling. Ensuring the identity and purity of this impurity is fundamental to meeting stringent pharmacopeial standards for drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Bosentan drug substances and products.
• Impurity Profiling and Identification: Essential for method development and validation in HPLC, UPLC, and LC-MS to identify, characterize, and quantify this specific impurity.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in in-process testing and release testing of active pharmaceutical ingredients (APIs) to ensure impurity levels are within ICH guidelines.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to monitor the formation of degradation products in Bosentan formulations under various stress conditions.
• Research and Development (R&D): Utilized in synthetic chemistry research to study the formation pathway and to develop purification processes for the main API.

Basic Information

Product Name	Bosentan Impurity
CAS No.	1268612-25-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bosentan Related Compound; Bosentan Process Impurity; Bosentan Specified Impurity; 4-tert-Butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzenesulfonamide (related impurity); Tracleer Impurity; Endothelin Receptor Antagonist Impurity; UNII-Contact for details
EINECS	Contact for details

Quality Control

Our Bosentan Impurity is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting our clients' needs for reliable and traceable impurities.

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 Certificate of Analysis. The container should be kept in a dry, well-ventilated area. For long-term storage, consider conditions recommended for high-value reference standards.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report individual and total impurities
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.