Description

Relugolix Impurity 66 is a designated impurity standard associated with the active pharmaceutical ingredient Relugolix. This high-purity reference material is critical for ensuring the quality, safety, and efficacy of pharmaceutical products during development and manufacturing. It is primarily utilized by analytical laboratories and pharmaceutical companies for method development, validation, and routine quality control testing of Relugolix drug substances and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Relugolix Impurity 66 in drug substances and products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC labs to ensure Relugolix batches meet stringent purity specifications per ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Research & Development: Supports process chemistry research to understand and minimize the formation of this impurity during synthesis.

Basic Information

Product Name	Relugolix Impurity 66
CAS No.	2591260-06-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Relugolix Related Compound 66; Relugolix Impurity C; Relugolix EP Impurity C; UNII-Contact for details; (2R)-2-({5-[(Dimethylamino)methyl]-1-(2-fluoro-6-{[4-(trifluoromethyl)pyridin-2-yl]oxy}benzyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl}thio)-3-(3-fluoro-5-{[4-(trifluoromethyl)pyridin-2-yl]oxy}phenyl)propanoic Acid (tentative); Relugolix Process Impurity; TAK-385 Impurity 66
EINECS	Contact for details

Quality Control

Every batch of Relugolix Impurity 66 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality assurance system is designed to meet the exacting standards of the pharmaceutical industry. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, identification (IR, MS), and residual solvent analysis.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material should be kept in a cool, dry, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.