Description

Sufugolix is a selective, non-steroidal gonadotropin-releasing hormone (GnRH) receptor antagonist developed for therapeutic applications in hormone-dependent conditions. It offers precise pharmacological control with high binding affinity and favorable pharmacokinetic properties, enabling reliable dosing in clinical and research settings. This compound is primarily utilized by pharmaceutical R&D laboratories, contract development and manufacturing organizations (CDMOs), and biotech firms engaged in the formulation and preclinical evaluation of next-generation endocrine therapies. Sufugolix CAS NO 308831-61-0 is supplied under strict quality governance to support regulatory-compliant development pathways.

Application

• Preclinical research on prostate cancer and uterine fibroids
• Active pharmaceutical ingredient (API) development for oral GnRH antagonist formulations
• Reference standard in bioanalytical method validation (LC-MS/MS, HPLC)
• Pharmacokinetic and metabolism studies (ADME) in animal models
• Stability-indicating assay development for regulatory submissions
• Comparative efficacy screening against other GnRH antagonists (e.g., relugolix, elagolix)
• Crystallization and solid-state characterization studies
• Impurity profiling and forced degradation studies

Basic Information

Product Name	Sufugolix
CAS No.	308831-61-0
Molecular Formula	C27H25F3N6O3
Molecular Weight	554.53 g/mol
Synonyms	1-(4-((2R,3R)-2-((S)-2-(3,5-Difluorophenyl)-2-hydroxyacetamido)-3-methoxybutanamido)phenyl)ethyl carbamate; TAK-385; TAK385; N-[4-[[(2R,3R)-2-[(1S)-1-(3,5-difluorophenyl)-2-hydroxyethyl]-3-methoxypropanoyl]amino]phenyl]ethoxycarbonylamine; Sufugolix free base; (2R,3R)-N-(4-((1-(ethoxycarbonylamino)ethyl)carbamoyl)phenyl)-2-((S)-2-(3,5-difluorophenyl)-2-hydroxyacetamido)-3-methoxypropanamide
EINECS	Not listed

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. All batches of Sufugolix are tested per ICH Q2(R2) guidelines for identification, assay, related substances, residual solvents, heavy metals, and water content. Testing is performed using validated methods including HPLC, GC, LC-MS, and KF titration. The material meets specifications suitable for pharmaceutical R&D use and is manufactured under ISO 9001-certified quality management systems.

Storage

Preserve in a tightly closed container, protected from light. Store at 15–25°C in a dry, well-ventilated area. Due to its hygroscopic nature, minimize exposure to ambient humidity and avoid repeated opening of the container. Handle under inert atmosphere (nitrogen or argon) when possible to prevent moisture uptake and potential degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0–102.0%
Related Substances	≤ 1.0% total impurities
Single Impurity	≤ 0.3%
Residual Solvents (GC)	Meets ICH Q3C limits
Water (KF)	≤ 0.5%
Heavy Metals	≤ 10 ppm
Residue on Ignition	≤ 0.1%

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