Description

Elagolix Sodium Impurity4 is a specified impurity of the active pharmaceutical ingredient Elagolix Sodium, a gonadotropin-releasing hormone (GnRH) antagonist. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for ensuring the purity, safety, and efficacy of Elagolix Sodium drug substances and products. Professionals in pharmaceutical R&D, quality assurance, and regulatory affairs rely on this high-purity impurity standard to meet stringent regulatory requirements.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Elagolix Sodium Impurity4 in drug substances and finished products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles during drug development and manufacturing.
• Quality Control & Batch Release: Used in QC laboratories to establish specification limits and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to determine product shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the impurity profile.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this impurity.

Basic Information

Product Name	Elagolix Sodium Impurity4
CAS No.	2248628-92-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Elagolix Related Compound; Elagolix Sodium Impurity D; Elagolix EP Impurity D; Elagolix USP Related Compound; 4-[[(1R)-2-[5-(2-Fluoro-3-methoxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-4-methyl-2,6-dioxo-3-pyrimidinyl]-1-phenylethyl]amino]butanoic acid sodium salt; Orilissa Impurity; GnRH Antagonist Impurity
EINECS	Contact for details

Quality Control

Our Elagolix Sodium Impurity4 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, residual solvent analysis (GC), and structural confirmation (NMR, MS) to ensure identity and purity. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data and results. Our quality commitment aligns with ICH Q3A/B and USP guidelines for pharmaceutical impurities, supporting your regulatory compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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