Description

Estradiol Impurity 7 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing estradiol. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control. The material is supplied with comprehensive analytical data to support method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Estradiol Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods (HPLC, GC) and spectroscopic techniques in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in estradiol formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Research & Development: Serves as a key intermediate or metabolite analog in pharmacological and toxicological studies related to estrogenic compounds.
• Quality Assurance/Quality Control (QA/QC): Used for routine batch testing to ensure estradiol products meet stringent pharmacopeial specifications (USP, EP, ICH).

Basic Information

Product Name	Estradiol Impurity 7
CAS No.	1852-86-4
Molecular Formula	C18H24O2
Molecular Weight	272.38 g/mol
Synonyms	8,9-Dehydroestradiol; Estra-1,3,5(10),8-tetraene-3,17β-diol; 8,9-Dehydro-17β-estradiol; 17β-Estra-1,3,5(10),8-tetraene-3,17-diol; 3,17β-Dihydroxyestra-1,3,5(10),8-tetraene; Estradiol 8,9-Dehydro Derivative; Estradiol Related Compound
EINECS	Contact for details

Quality Control

Every batch of Estradiol Impurity 7 is manufactured and tested under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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