Description

Estradiol Impurity 5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products containing estradiol by enabling accurate identification and quantification of related substances. It is an essential tool for analytical chemists and quality control laboratories in the pharmaceutical and biotechnology sectors. This material supports compliance with stringent regulatory requirements for drug development and manufacturing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Estradiol Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, in quality control laboratories.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of degradation products in estradiol-based formulations.
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Quality Control and Batch Release: Acts as a system suitability standard and for routine quality control testing to ensure batch-to-batch consistency and purity of estradiol.
• Research and Development: Used in academic and industrial R&D settings for studying the metabolism, degradation pathways, and analytical behavior of estradiol and its analogs.

Basic Information

Product Name	Estradiol Impurity 5
CAS No.	345317-41-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Estradiol Related Compound 5; Estradiol Impurity C; 17β-Estradiol Impurity 5; 1,3,5(10)-Estratrien-3,17β-diol Impurity; Estra-1,3,5(10)-triene-3,17β-diol Impurity 5; 345317-41-1; Estradiol EP Impurity C
EINECS	Contact for details

Quality Control

Our Estradiol Impurity 5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) providing batch-specific results is supplied with every shipment to support your quality and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term stability, consider storage at 2-8°C. Handle the material in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines

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