Description

Fulvestrant 9-Sulfone CAS NO 98008-06-1 is a high-purity synthetic organic compound, specifically a key sulfone metabolite of the selective estrogen receptor degrader (SERD) Fulvestrant. This compound is of significant importance in pharmaceutical research and development, serving as a critical reference standard and an advanced intermediate. It is primarily needed by research institutions, pharmaceutical companies, and contract development and manufacturing organizations (CDMOs) engaged in the synthesis, metabolism studies, and analytical method development for hormone-based cancer therapies.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the quantitative and qualitative analysis of Fulvestrant and its metabolites in drug substances and products via HPLC, LC-MS, or GC-MS.
• Metabolite Studies: Essential for in-vitro and in-vivo pharmacokinetic and pharmacodynamic (PK/PD) research to understand the metabolic pathway and biological activity of Fulvestrant.
• Process Chemistry & Impurity Profiling: Employed as a marker to monitor synthesis processes, optimize reaction conditions, and control related substance levels during the manufacturing of Fulvestrant API.
• Bioanalytical Method Development: Serves as a critical calibrant for developing and validating sensitive analytical methods in biological matrices for clinical trial support.
• Stability Testing: Used to identify and quantify degradation products in stability studies of Fulvestrant formulations to ensure shelf-life and efficacy.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., with FDA, EMA) as part of the impurity and metabolite identification package.

Basic Information

Product Name	Fulvestrant 9-Sulfone
CAS No.	98008-06-1
Molecular Formula	C32H47F5O4S
Molecular Weight	622.77 g/mol
Synonyms	7α-[9-(4,4,5,5,5-Pentafluoropentylsulfinyl)nonyl]estra-1,3,5(10)-triene-3,17β-diol; Fulvestrant Sulfoxide; ICI 182,780 Sulfone; Faslodex Metabolite (Sulfone); (7α,17β)-7-{9-[(4,4,5,5,5-Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10)-triene-3,17-diol
EINECS	Contact for details

Quality Control

Our Fulvestrant 9-Sulfone is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including identity confirmation by spectroscopic methods (NMR, IR, MS), purity determination by HPLC, and control of specific impurities. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to ensure traceability and compliance with research and development standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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