Description

Fulvestrant Impurity 4 CAS NO 1621885-82-2 is a high-purity reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Fulvestrant. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is essential for research and development, stability studies, and the routine batch release testing of Fulvestrant drug substances and finished products.

Application

• Primary use as a certified reference standard for the identification and quantification of Fulvestrant Impurity 4 in Fulvestrant API and drug products.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for impurity profiling.
• Essential for conducting stability and forced degradation studies to understand the degradation pathways of Fulvestrant.
• Used in quality control laboratories for routine batch analysis to ensure compliance with ICH Q3A/B guidelines.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive impurity characterization data.
• Valuable for pharmaceutical R&D in process chemistry optimization to minimize impurity formation.

Basic Information

Item	Detail
Product Name	Fulvestrant Impurity 4
CAS No.	1621885-82-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fulvestrant Related Compound 4; Fulvestrant EP Impurity D; Fulvestrant USP Impurity; 7α-[9-(4,4,5,5,5-Pentafluoropentylsulfinyl)nonyl]estra-1,3,5(10)-triene-3,17β-diol (Sulfide Impurity); Fulvestrant Sulfoxide Impurity; ICI 182,780 Impurity 4; (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 Impurity 4 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is subjected to comprehensive analytical testing, including HPLC purity determination, identity confirmation by spectroscopic methods, and stringent control of related substances. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with relevant specifications.

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 Certificate of Analysis. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. The container should be opened under inert atmosphere and resealed immediately after use to minimize exposure to moisture.

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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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