Description

Relugolix Impurity 17 is a designated process-related impurity or degradation product of the active pharmaceutical ingredient Relugolix. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable materials for impurity profiling and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of impurities in Relugolix drug substance and finished products.
• Analytical Method Development: Used to develop and optimize chromatographic methods (e.g., HPLC, UPLC) for impurity separation and detection.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity levels, ensuring product safety and efficacy.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions to establish product shelf-life.
• Research & Development: Aids in understanding the degradation pathways and chemical behavior of Relugolix during synthesis and formulation.

Basic Information

Product Name	Relugolix Impurity 17
CAS No.	1801551-07-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Relugolix Related Compound 17; Relugolix EP Impurity G; Relugolix USP Impurity; NBI-56418 Impurity; TAK-385 Impurity; (3S)-3-[5-[(2,6-difluorobenzyl)oxy]-1-(2-fluoro-6-methylbenzyl)-2,4-dioxo-3-propyl-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl]-2,2-dimethylpropanoic acid (tentative)
EINECS	Contact for details

Quality Control

Our Relugolix Impurity 17 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

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 area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
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.