Description

Bosentan Impurity CAS NO 1257099-43-6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Bosentan, a dual endothelin receptor antagonist. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Bosentan drug substance and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component in developing and validating stability-indicating methods for Bosentan.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in pharmaceutical manufacturing to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing characterized impurity data for health authorities like the FDA and EMA.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions as per ICH Q1A(R2).
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Bosentan.

Basic Information

Product Name	Bosentan Impurity
CAS No.	1257099-43-6
Molecular Formula	C27H29N5O6S
Molecular Weight	551.61 g/mol
Synonyms	Bosentan Related Compound; Bosentan Impurity Standard; 4-tert-Butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzenesulfonamide; UNII-7VMA15J2QO; 7VMA15J2QO; Benzenesulfonamide, 4-(1,1-dimethylethyl)-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(2-pyrimidinyl)-4-pyrimidinyl]-
EINECS	Contact for details

Quality Control

Every batch of Bosentan Impurity (CAS 1257099-43-6) 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) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

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)	Any individual 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.