Description

Fulvestrant Ep Impurity B is a designated impurity of the active pharmaceutical ingredient Fulvestrant, a selective estrogen receptor degrader (SERD). This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Fulvestrant drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Fulvestrant API and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation and behavior of this specific impurity under various stress conditions.
• Research & Development: Supports studies on the degradation pathways and chemical behavior of Fulvestrant.

Basic Information

Product Name	Fulvestrant Ep Impurity B
CAS No.	1621885-80-0
Molecular Formula	C32H47F5O3S
Molecular Weight	606.78 g/mol
Synonyms	Fulvestrant Impurity B; Fulvestrant EP Impurity B; Fulvestrant Related Compound B; (7R,8R,9S,13S,14S,17S)-17-{[(1E)-1,1,1,3,3,3-Hexafluoro-2-(4-fluorophenyl)propan-2-yl]sulfanyl}-13-methyl-7-{9-[(4,4,5,5,5-pentafluoropentyl)sulfanyl]nonyl}-6,7,8,9,11,12,13,14,15,16-decahydrocyclopenta[a]phenanthrene-3,17-diol; Fulvestrant Sulfoxide Impurity; ICI 182,780 Impurity B
EINECS	Contact for details

Quality Control

Our Fulvestrant Ep Impurity B is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS), to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability.

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 ≤ 0.10% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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