Description

Elagolix Impurity 4 CAS NO 2486454-63-9 is a high-purity reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient Elagolix. This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is primarily used in research and development, method validation, and routine quality testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Elagolix Impurity 4 in drug substance and drug product batches.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Elagolix.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for preparing calibration curves in routine QC testing to monitor impurity levels against ICH guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and demonstrate control strategies.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress and long-term storage conditions.
• Process Chemistry Research: Used to study and optimize synthesis pathways to minimize the formation of this impurity during Elagolix manufacturing.

Basic Information

Item	Detail
Product Name	Elagolix Impurity 4
CAS No.	2486454-63-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Elagolix Related Compound 4; Elagolix EP Impurity 4; Elagolix USP Impurity 4; Elagolix Process Impurity 4; 4-[(2R)-2-[5-(2-Fluoro-3-methoxyphenyl)-3-methyl-1,2-oxazol-4-yl]pyrrolidin-1-yl]benzonitrile (tentative); UNII-Contact for details; Elagolix Specified Impurity 4
EINECS	Contact for details

Quality Control

Every batch of Elagolix Impurity 4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and strength conform to the highest standards suitable for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
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.