Description

Macitentan Impurity A 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 drug 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 dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating stability-indicating analytical methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: A critical component in routine QC testing to ensure API batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Process Chemistry: Used to study the formation pathways of this impurity during the synthesis of Macitentan, aiding in process optimization and impurity minimization.

Basic Information

Product Name	Macitentan Impurity A
CAS No.	441798-25-0
Molecular Formula	C19H14Br2N6O4S
Molecular Weight	582.22 g/mol
Synonyms	N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide; Propylsulfamide Impurity A of Macitentan; Macitentan Related Compound A; UNII-8C4C4C6T0P; Macitentan EP Impurity A; Macitentan USP Impurity A; Opsumit Impurity A
EINECS	Contact for details

Quality Control

Our Macitentan Impurity A is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity. Certificates of Analysis (COA) are provided, detailing batch-specific results and traceability. The material is suitable for use in compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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