Description

Fulvestrant 3-β-D-Glucuronide 17-Acetate is a high-purity, synthetic reference standard and key intermediate in the development and production of advanced pharmaceutical compounds. This compound is critical for analytical research, method validation, and quality control processes in the manufacture of active pharmaceutical ingredients (APIs). It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers specializing in oncology and endocrine therapies.

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: Serves as a critical standard in pharmacokinetic and pharmacodynamic studies to understand the metabolic pathway and clearance of Fulvestrant.
• Analytical Method Development: Essential for developing and validating high-performance liquid chromatography (HPLC), LC-MS/MS, and other chromatographic methods in quality control laboratories.
• Impurity Profiling: Employed to identify, quantify, and monitor process-related impurities and degradation products during API manufacturing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with the FDA, EMA) to demonstrate analytical control and product consistency.
• Stability Studies: Acts as a benchmark in forced degradation and long-term stability testing of pharmaceutical formulations containing Fulvestrant.

Basic Information

Product Name	Fulvestrant 3-β-D-Glucuronide 17-Acetate
CAS No.	403656-84-8
Molecular Formula	C34H43FO11S
Molecular Weight	678.77 g/mol
Synonyms	Fulvestrant 3-Glucuronide 17-Acetate; Fulvestrant Glucuronide Acetate; 7α-[9-(4,4,5,5,5-Pentafluoropentylsulfinyl)nonyl]estra-1,3,5(10)-triene-3,17β-diol 3-β-D-Glucopyranosiduronic Acid 17-Acetate; ICI 182,780 Glucuronide Acetate; Faslodex Metabolite Standard
EINECS	Contact for details

Quality Control

Our Fulvestrant 3-β-D-Glucuronide 17-Acetate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Meets ICH guidelines
Heavy Metals	< 20 ppm

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