Description

Macitentan Hydroxy Amine Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of Macitentan, an endothelin receptor antagonist. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method validation, stability studies, and impurity profiling to meet stringent ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the hydroxy amine impurity in Macitentan API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels throughout the manufacturing process.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial specifications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as per ICH Q1A(R2) requirements.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification reports required by regulatory bodies like the FDA, EMA, and PMDA.
• Process Chemistry Research: Used by R&D scientists to understand and optimize synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Macitentan Hydroxy Amine Impurity
CAS No.	2211059-05-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Macitentan Impurity H; Macitentan Hydroxy Amine; Macitentan Related Compound H; N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide hydroxy amine; Opsumit Impurity H; ACT-064992 Hydroxy Amine Impurity; Endothelin Receptor Antagonist Impurity
EINECS	Contact for details

Quality Control

Our Macitentan Hydroxy Amine Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, MS, and NMR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data on purity, impurities, and residual solvents. We support compliance with ICH Q3A, Q3B, and Q6A guidelines, and our quality systems are designed to meet the needs of cGMP manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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