Description

Bosentan Related Compound 4 is a high-purity chemical reference standard, identified by CAS NO 1160515-53-6. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Bosentan through rigorous analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for use in method development, validation, and quality control processes.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Bosentan API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to meet ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Release Testing: Essential for routine batch analysis in pharmaceutical QC laboratories to ensure compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to monitor the formation of degradation products in Bosentan formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in preclinical and clinical research to understand the metabolism and degradation pathways of Bosentan.

Basic Information

Product Name	Bosentan Related Compound 4
CAS No.	1160515-53-6
Molecular Formula	C27H29N5O6S
Molecular Weight	551.61 g/mol
Synonyms	Bosentan Impurity 4; Bosentan EP Impurity D; Bosentan Related Substance 4; 4-tert-Butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzenesulfonamide; Bosentan Sulfonamide Derivative; Tracleer Related Compound 4; BOS-Imp-4
EINECS	Contact for details

Quality Control

Every batch of Bosentan Related Compound 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The product is hygroscopic (moisture-sensitive) and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)

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