Description

Macitentan Impurity 17 is a designated impurity of the active pharmaceutical ingredient Macitentan, an endothelin receptor antagonist used to treat pulmonary arterial hypertension. This compound is of critical importance for pharmaceutical research and development, serving as a key reference standard in analytical method development, stability studies, and quality control processes to ensure drug safety and efficacy. It is primarily needed by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the synthesis, purification, and rigorous testing of Macitentan.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Macitentan drug substance and finished products.
• Method Development and Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor and control impurity profiles.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to identify and quantify degradation products.
• Quality Control & Assurance: A critical component in the batch release testing of Macitentan to ensure compliance with ICH guidelines and pharmacopeial standards.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify the control strategy.
• Process Chemistry Research: Used to study and optimize the synthetic pathway of Macitentan to minimize the formation of this specific impurity.

Basic Information

Product Name	Macitentan Impurity 17
CAS No.	615571-91-0
Molecular Formula	C19H14Br2N6O4S
Molecular Weight	582.22 g/mol
Synonyms	Macitentan Related Compound 17; Macitentan EP Impurity J; Macitentan USP Impurity; 5-(4-Bromophenyl)-6-[2-(5-bromopyrimidin-2-yl)oxyethoxy]pyrimidine-4-carboxylic acid; N-[5-(4-Bromophenyl)-6-[2-(5-bromopyrimidin-2-yl)oxyethoxy]pyrimidin-4-yl]-N'-propylsulfamide (process intermediate derivative); ACT-064992 Impurity; Opsumit Impurity
EINECS	Contact for details

Quality Control

Every batch of Macitentan Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. Quality is assured with reference to relevant ICH Q3A, Q3B, and pharmacopeial (USP, EP) guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after each use to prevent absorption of atmospheric moisture, which could affect purity and stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5%; Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
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.