Description

Macitentan Impurity 33 is a designated impurity standard used in the pharmaceutical development and quality control of Macitentan, an endothelin receptor antagonist. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, pharmaceutical manufacturers, and research institutions involved in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Macitentan API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor and control impurity levels.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions during drug shelf-life studies.
• Quality Control & Batch Release: A critical tool for in-process testing and final release testing of Macitentan to ensure it meets stringent pharmacopeial specifications (e.g., ICH Q3A/B).
• Regulatory Submissions: Provides necessary data on impurity identity and levels for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during the drug development process.

Basic Information

Product Name	Macitentan Impurity 33
CAS No.	2089065-77-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Macitentan Related Compound 33; Macitentan EP Impurity 33; Macitentan USP Impurity 33; N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide; UNII-9F4WYA8S4M; 9F4WYA8S4M; Sulfamide, N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propyl-
EINECS	Contact for details

Quality Control

Every batch of Macitentan Impurity 33 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions if the container is opened frequently to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with customer requirements
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.