Description

Macitentan Impurity CAS NO 556796-88-4 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Macitentan, a potent endothelin receptor antagonist. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and batch release testing to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Macitentan API and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing, optimizing, and validating chromatographic methods to ensure accurate impurity detection.
• Quality Control and Assurance (QC/QA): Essential for routine batch analysis in pharmaceutical manufacturing to confirm impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance and Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed to monitor the formation and growth of this specific impurity during forced degradation and long-term stability testing of drug substances and products.
• Research and Development (R&D): Used in synthetic chemistry R&D to understand degradation pathways and to develop robust purification processes for the API.

Basic Information

Product Name	Macitentan Impurity
CAS No.	556796-88-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Macitentan Related Compound; Macitentan Process Impurity; Macitentan Degradant; N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide (possible structure-based name); Propylsulfamide impurity of Macitentan; OPSUMIT Impurity
EINECS	Contact for details

Quality Control

Every batch of Macitentan Impurity (CAS 556796-88-4) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider conditions recommended for pharmaceutical 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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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