Description

Fulvestrant Impurity 7 is a designated impurity standard used in 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 the purity, safety, and efficacy of the final drug product. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Fulvestrant Impurity 7 in Fulvestrant API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles during stability studies.
• Quality Control & Batch Release: Used in routine QC testing to confirm that impurity levels in commercial batches are within International Council for Harmonisation (ICH) guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing impurity characterization data and setting appropriate specification limits.
• Stability Studies: Helps track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes for Fulvestrant by identifying and controlling the source of this impurity.

Basic Information

Product Name	Fulvestrant Impurity 7
CAS No.	1673530-91-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fulvestrant Related Compound 7; Fulvestrant EP Impurity 7; Fulvestrant USP Impurity 7; (7R,8S,9S,13S,14S,17S)-17-Hydroxy-13-methyl-7-[9-(4,4,5,5,5-pentafluoropentylsulfinyl)nonyl]-6,7,8,9,11,12,13,14,15,16-decahydrocyclopenta[a]phenanthren-3-one; Fulvestrant Process Impurity; ICI 182,780 Impurity 7
EINECS	Contact for details

Quality Control

Our Fulvestrant Impurity 7 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic techniques (NMR, MS) for structural verification, to ensure compliance with pharmacopeial standards (USP/EP). 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 at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
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.