Description

Fulvestrant Ep Impurity E is a designated impurity reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Fulvestrant. This compound is critical for ensuring the quality, safety, and efficacy of the final drug product by enabling accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments involved in the development and manufacturing of Fulvestrant-based therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Fulvestrant API and drug products.
• Analytical Method Development: Used to establish and optimize chromatographic conditions (e.g., HPLC, UPLC) for the precise separation and detection of specific impurities.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Stability Studies: Employed as a marker to monitor impurity formation and degradation pathways in Fulvestrant formulations under various stress conditions.
• Process Chemistry Optimization: Used by chemical development teams to identify and mitigate the formation of this specific impurity during the API synthesis and purification stages.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP) that specify limits for related substances.

Basic Information

Product Name	Fulvestrant Ep Impurity E
CAS No.	2170200-14-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fulvestrant Related Compound E; Fulvestrant Impurity E; 7α-[9-(4,4,5,5,5-Pentafluoropentylsulfinyl)nonyl]estra-1,3,5(10)-triene-3,17β-diol Impurity; Fulvestrant EP Impurity E; Fulvestrant Process Impurity E; ICI 182,780 Impurity E
EINECS	Contact for details

Quality Control

Every batch of Fulvestrant Ep Impurity E is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical characterization using advanced techniques such as HPLC, NMR, and MS to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality standards are designed to meet the rigorous demands of pharmaceutical reference material applications, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store under an inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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