Description

Ethynodiol Impurity (17-Alfa-Ethinyl-17-β-Acettoxy-3,5-Estradien Impurity) is a high-purity chemical reference standard, specifically a process-related impurity of the synthetic progestin ethynodiol diacetate. This compound is critical for pharmaceutical research and development, serving as a key marker for ensuring the purity, safety, and efficacy of active pharmaceutical ingredients (APIs). It is primarily required by analytical laboratories, quality control departments, and R&D teams within the pharmaceutical and biotechnology sectors for method development, validation, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of related substances in ethynodiol diacetate and its derivative drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods to monitor synthetic processes and final product quality.
• Quality Control & Assurance: Essential for routine batch testing in QC laboratories to ensure API and finished drug product specifications meet pharmacopeial standards (e.g., USP, EP).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Stability Studies: Employed as a reference to track the formation of degradation products under various stress conditions.
• Chemical Research: Used in academic and industrial research focused on steroid chemistry, metabolism studies, and synthetic pathway optimization.

Basic Information

Product Name	Ethynodiol Impurity (17-Alfa-Ethinyl-17-β-Acettoxy-3,5-Estradien Impurity)
CAS No.	64850-62-0
Molecular Formula	C24H30O3
Molecular Weight	366.50 g/mol
Synonyms	17α-Ethynyl-17β-acetoxy-3,5-estradiene; 17α-Ethynyl-17β-hydroxyestra-3,5-dien-3-yl acetate; 3,5-Estradien-17β-ol, 17α-ethynyl-, acetate; Ethynodiol Diacetate Impurity; Ethynodiol Related Compound A; 17-Ethynyl-17-hydroxyestra-3,5-dien-3-yl acetate; NSC 121698
EINECS	Contact for details

Quality Control

Every batch of Ethynodiol Impurity (CAS 64850-62-0) is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to support pharmaceutical applications, with testing typically including HPLC for assay and related substances, IR for identification, and residual solvent analysis. A comprehensive Certificate of Analysis (COA) detailing all test results and methods is provided with each shipment to support your regulatory and quality requirements.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 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.