Description

Ethinyl Estradiol Dimer Impurity 2 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities in active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) for method development and validation in HPLC, UPLC, and LC-MS analyses.
• Quality Control and Release Testing: Serves as a system suitability standard and for setting specification limits in the quality control of Ethinyl Estradiol and related steroid APIs.
• Regulatory Submissions and Compliance: Provides essential data for Investigational New Drug (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA) filings to agencies like the FDA and EMA.
• Stability Studies: Employed to monitor the formation and growth of this specific dimer impurity over time under various stress conditions.
• Process Chemistry Optimization: Helps chemists identify the source of the impurity during API synthesis, enabling process refinement to minimize its formation.
• Pharmacopoeial Testing: Supports testing in compliance with monographs from USP, EP, BP, and other international pharmacopoeias.

Basic Information

Product Name	Ethinyl Estradiol Dimer Impurity 2
CAS No.	303014-91-7
Molecular Formula	C40H48O4
Molecular Weight	592.81 g/mol
Synonyms	19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol dimer impurity; EE Dimer Impurity B; Ethinylestradiol Dimer; 17α-Ethynylestra-1,3,5(10)-triene-3,17β-diol dimer; Steroid dimer impurity; Process impurity of Ethinyl Estradiol; Related compound of Ethinyl Estradiol
EINECS	Contact for details

Quality Control

Every batch of Ethinyl Estradiol Dimer Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques including HPLC, GC, NMR, and MS to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and storage recommendations.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. This material is light-sensitive (store away from light). For long-term storage, consider storing desiccated at 2-8°C.

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)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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