Description

Fulvestrant Impurity 3 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Fulvestrant API manufacturing, serving as a key marker for process-related impurities. It is primarily required by analytical laboratories, quality assurance departments, and R&D teams within the pharmaceutical and biotechnology sectors to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Fulvestrant Active Pharmaceutical Ingredient (API) batches.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used as a marker to track impurity formation during forced degradation and long-term stability studies of Fulvestrant drug products.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway of Fulvestrant to minimize the formation of this specific impurity.

Basic Information

Product Name	Fulvestrant Impurity 3
CAS No.	1621885-81-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fulvestrant Related Compound 3; Fulvestrant EP Impurity C; Fulvestrant USP Impurity; (7α,17β)-7-{9-[(4,4,5,5,5-Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10)-triene-3,17-diol (Sulfide Impurity); Fulvestrant Sulfoxide Impurity; ICI 182,780 Impurity; ZD9238 Impurity
EINECS	Contact for details

Quality Control

Our Fulvestrant Impurity 3 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under inert atmosphere if recommended for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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