Description

Macitentan Impurity 2 is a designated impurity standard of the active pharmaceutical ingredient Macitentan, a potent endothelin receptor antagonist. This high-purity reference material is critical for ensuring the quality, safety, and efficacy of Macitentan drug products by enabling accurate identification and quantification of this specific impurity during pharmaceutical development and manufacturing. It is an essential tool for analytical chemists and quality control laboratories in the pharmaceutical industry, particularly those involved in the production of pulmonary arterial hypertension (PAH) therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Macitentan.
• Method Development and Validation: Critical for developing and validating robust analytical methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control and Batch Release: Used in QC labs to monitor and control the levels of this specific impurity in active pharmaceutical ingredient (API) and finished drug product batches to comply with ICH guidelines.
• Stability Studies: Employed to identify and track the formation of degradation products in stability testing of Macitentan under various conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research and Development: Supports synthetic route optimization and process chemistry research by identifying and quantifying process-related impurities.

Basic Information

Product Name	Macitentan Impurity 2
CAS No.	2211054-90-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Macitentan Related Compound 2; Macitentan EP Impurity 2; Macitentan USP Impurity 2; Macitentan Process Impurity; N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide (likely structure); ACT-064992 Impurity; Opsumit Impurity
EINECS	Contact for details

Quality Control

Every batch of Macitentan Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopeial monographs (e.g., USP, EP). Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profile are 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. For long-term storage, consider storing desiccated at 2-8°C.

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
Water Content (KF)	≤ 5.0%

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