Description

Fulvestrant Ep Impurity C is a designated impurity reference standard used in the analytical profiling of the active pharmaceutical ingredient, Fulvestrant. This compound is critical for ensuring the purity, safety, and efficacy of Fulvestrant drug substances and products through rigorous quality control protocols. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and compliance testing of oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Fulvestrant Ep Impurity C in Fulvestrant API and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Fulvestrant formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity characterization and control strategies.
• Research and Development: Supports impurity profiling and route scouting during the synthetic process development of Fulvestrant.

Basic Information

Item	Detail
Product Name	Fulvestrant Ep Impurity C
CAS No.	2482852-42-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fulvestrant EP Impurity C; Fulvestrant Related Compound C; Fulvestrant Impurity C; (7α,17β)-7-{9-[(4,4,5,5,5-Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10)-triene-3,17-diol (Sulfoxide Isomer); Fulvestrant Sulfoxide Impurity; ICI 182,780 Impurity C
EINECS	Contact for details

Quality Control

Our Fulvestrant Ep Impurity C is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS) and purity determination by HPLC, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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