Description

Ethinyl Estradiol Dimer Impurity 1 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 used by analytical chemists, quality control laboratories, and regulatory affairs professionals within the global pharmaceutical and biotechnology industries to ensure product safety, efficacy, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for method development and validation in HPLC and LC-MS analyses.
• Quality Control and Assurance (QC/QA): Used as a system suitability standard and for setting impurity acceptance criteria in batch release testing.
• Regulatory Submission and Compliance: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH requirements.
• Stability Studies: Employed to monitor the formation of degradation products in drug substance and drug product stability programs.
• Process Chemistry Optimization: Helps chemists identify and eliminate the root cause of impurity formation during API synthesis and scale-up.
• Pharmacopoeial Testing: Supports testing as per USP, EP, and other pharmacopoeial monographs for related substances.

Basic Information

Product Name	Ethinyl Estradiol Dimer Impurity 1
CAS No.	303014-90-6
Molecular Formula	C40H48O4
Molecular Weight	592.82 g/mol
Synonyms	19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol dimer impurity; EE Dimer Impurity; Ethinylestradiol Dimer; 17α-Ethynylestra-1,3,5(10)-triene-3,17β-diol dimer; Dimer of Ethinyl Estradiol; Process Impurity of Ethinyl Estradiol; Related Substance A of Ethinyl Estradiol
EINECS	Contact for details

Quality Control

Every batch of Ethinyl Estradiol Dimer Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure compliance with industry standards and customer specifications. Certificates of Analysis (COA) detailing batch-specific results from HPLC, NMR, and MS are provided and available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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)	≤ 1.0% w/w

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