Description

3-o-Methyl Fulvestrant is a synthetic steroidal antiestrogen and a key metabolite of the active pharmaceutical ingredient Fulvestrant. This compound serves as a critical reference standard and an important intermediate in pharmaceutical research and development. It is primarily utilized by research institutions and pharmaceutical companies engaged in the development and quality control of hormone receptor-targeting cancer therapies. The high-purity material is essential for analytical method validation, pharmacokinetic studies, and metabolic profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Fulvestrant and its metabolites in drug substances and products.
• Metabolite Research: Critical for in vitro and in vivo studies investigating the metabolic pathways, pharmacokinetics, and bioavailability of Fulvestrant.
• Analytical Method Development: Serves as a key component in developing and validating high-performance liquid chromatography (HPLC), LC-MS/MS, and other chromatographic methods for impurity profiling.
• Drug Impurity Characterization: Employed to identify, quantify, and monitor process-related impurities and degradation products during Fulvestrant API manufacturing.
• Biomedical Research: Used as a tool compound in preclinical research to study estrogen receptor (ER) antagonism, downregulation, and resistance mechanisms in hormone-dependent cancers.
• Quality Control (QC) & Quality Assurance (QA): Essential for ensuring batch-to-batch consistency and compliance with regulatory specifications (e.g., ICH guidelines) in pharmaceutical production.

Basic Information

Product Name	3-o-Methyl Fulvestrant
CAS No.	1221256-46-7
Molecular Formula	C32H47F5O3S
Molecular Weight	606.78 g/mol
Synonyms	3-O-Methyl Fulvestrant; Fulvestrant 3-Methyl Ether; 7α-[9-(4,4,5,5,5-Pentafluoropentylsulfinyl)nonyl]estra-1,3,5(10)-triene-3,17β-diol 3-Methyl Ether; ICI 182,780 Metabolite; FASLODEX® Metabolite; (7α,17β)-7-{9-[(4,4,5,5,5-Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10)-triene-3,17-diol 3-Methyl Ether
EINECS	Contact for details

Quality Control

Our 3-o-Methyl Fulvestrant is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis, and identity confirmation (IR, MS) to ensure it meets the high standards required for pharmaceutical research. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications 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. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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