Description

Fulvestrant 3-β-D-Glucuronide is a key glucuronide metabolite of the selective estrogen receptor degrader (SERD) Fulvestrant, widely used in pharmaceutical research and development. This high-purity reference standard is critical for conducting accurate bioanalytical studies, including metabolite profiling, pharmacokinetic analysis, and drug metabolism and pharmacokinetics (DMPK) investigations. It is an essential material for pharmaceutical companies, contract research organizations (CROs), and academic institutions focused on oncology drug development and regulatory submission support.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantification and identification of Fulvestrant metabolites in biological matrices.
• Bioanalytical Method Development: Used to develop and validate sensitive LC-MS/MS or HPLC-UV methods for pharmacokinetic (PK) and toxicokinetic (TK) studies.
• Drug Metabolism Studies: Essential for in vitro and in vivo studies to understand the metabolic pathways and clearance mechanisms of Fulvestrant.
• DMPK (Drug Metabolism and Pharmacokinetics): A critical tool for assessing the absorption, distribution, metabolism, and excretion (ADME) profile of Fulvestrant and related SERDs.
• Regulatory Compliance & Submission: Supports the generation of data required for regulatory filings with agencies like the FDA and EMA by providing a traceable metabolite standard.
• Quality Control in API Manufacturing: Used to monitor and control potential glucuronide-related impurities during the active pharmaceutical ingredient (API) manufacturing process.

Basic Information

Product Name	Fulvestrant 3-β-D-Glucuronide
CAS No.	261506-27-8
Molecular Formula	C32H43FO8S • (C6H9NO6)
Molecular Weight	Contact for details
Synonyms	Fulvestrant 3-Glucuronide; Fulvestrant Glucuronide; ICI 182,780 Glucuronide; 7α-[9-(4,4,5,5,5-Pentafluoropentyl)sulfinyl]nonyl]estra-1,3,5(10)-triene-3,17β-diol 3-β-D-Glucopyranosiduronic Acid; Faslodex Metabolite; Estrogen Receptor Antagonist Glucuronide
EINECS	Contact for details

Quality Control

Our Fulvestrant 3-β-D-Glucuronide is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (NMR, MS), to ensure it meets the high standards required for pharmaceutical research. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. 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 (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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