Description

Macitentan Impurity 16 is a designated impurity reference standard used in the pharmaceutical development and quality control of Macitentan, an endothelin receptor antagonist. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by serving as a benchmark for identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, process validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for analytical method development and validation in accordance with ICH guidelines.
• Quality Control (QC) Testing: Essential for the identification, qualification, and control of this specific impurity during the release testing of Macitentan API and finished drug products.
• Stability Studies: Employed to monitor the formation and levels of Macitentan Impurity 16 in stability samples under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Macitentan to minimize the formation of this impurity.
• Pharmacopoeial Testing: Supports testing to meet the requirements of pharmacopoeial monographs where applicable.

Basic Information

Product Name	Macitentan Impurity 16
CAS No.	2211054-17-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Macitentan Related Compound 16; Macitentan EP Impurity J; Macitentan USP Impurity; Macitentan Process Impurity; 5-(4-Bromophenyl)-6-[2-(5-bromopyrimidin-2-yl)oxyethoxy]pyrimidin-4-amine (Proposed); UNII-7Y3J6Q8V8F; Macitentan Impurity J (EP); Macitentan Impurity (EP)
EINECS	Contact for details

Quality Control

Our Macitentan Impurity 16 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure identity, strength, and composition. Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to high-purity reference materials. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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