Description

Macitentan Impurity 11 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Macitentan. This compound is critical for ensuring the purity, safety, and efficacy of the final pharmaceutical product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Macitentan API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure compliance with pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Macitentan.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and improve the manufacturing process of Macitentan.

Basic Information

Item	Details
Product Name	Macitentan Impurity 11
CAS No.	1642873-04-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Macitentan Related Compound 11; Macitentan EP Impurity J; Macitentan USP Impurity 11; Macitentan Process Impurity; N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide; Propylsulfamide impurity of Macitentan; Opsumit Impurity 11
EINECS	Contact for details

Quality Control

Our Macitentan Impurity 11 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and identification.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C

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