Description

Bosentan Impurity 1 is a specified impurity of the active pharmaceutical ingredient (API) 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, validation, and quality control processes. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Bosentan-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Bosentan API and finished drug products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish product shelf life.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and develop purification processes.

Basic Information

Product Name	Bosentan Impurity 1
CAS No.	1218951-81-5
Molecular Formula	C27H29N5O6S
Molecular Weight	551.61 g/mol
Synonyms	Bosentan Related Compound 1; Bosentan Impurity A; 4-tert-Butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzenesulfonamide; 4-(1,1-Dimethylethyl)-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(2-pyrimidinyl)-4-pyrimidinyl]benzenesulfonamide; UNII-8F3Y1F8Q5F; 8F3Y1F8Q5F
EINECS	Contact for details

Quality Control

Every batch of Bosentan Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The container should be kept in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches 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.