Description

17Alpha-Ethynylestradiol-2,4,16,16-D4 is a high-purity, deuterium-labeled analog of the synthetic estrogen ethynylestradiol, a key component in many oral contraceptive formulations. This stable isotope-labeled compound is essential for use as an internal standard in quantitative analytical methods, ensuring accuracy and reliability in complex biological matrices. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities specializing in bioanalytical method development, pharmacokinetic studies, and drug metabolism research.

Application

• Bioanalytical Internal Standard: Serves as a critical reference compound in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of ethynylestradiol in plasma, serum, and other biological samples.
• Pharmacokinetic & Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) for hormone-based therapeutics.
• Clinical Research & Drug Development: Supports method validation and compliance with Good Laboratory Practice (GLP) and FDA/EMA bioanalytical method guidance in clinical trials.
• Environmental & Forensic Analysis: Used as a labeled standard for detecting and quantifying synthetic estrogen residues in environmental water samples and forensic toxicology.
• Pharmaceutical Quality Control: Applied in the analysis of finished pharmaceutical products (FPPs) and active pharmaceutical ingredient (API) batches for potency and purity verification.

Basic Information

Product Name	17Alpha-Ethynylestradiol-2,4,16,16-D4
CAS No.	350820-06-3
Molecular Formula	C20H20D4O2
Molecular Weight	300.42 g/mol
Synonyms	Ethynylestradiol-d4; 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol-d4; EE2-d4; Deuterated Ethinyl Estradiol; 17α-Ethynyl-1,3,5(10)-estratriene-3,17β-diol-2,4,16,16-d4; NSC-10973-d4; 17α-Ethynylestra-1,3,5(10)-triene-3,17β-diol-2,4,16,16-d4
EINECS	Contact for details

Quality Control

Our deuterated compounds are manufactured under strict quality systems to ensure the high isotopic purity and chemical integrity required for analytical applications. Each batch is characterized by advanced spectroscopic techniques, including NMR and Mass Spectrometry, to confirm deuteration level and structural identity. Certificates of Analysis (COA) are provided, detailing specifications for chemical purity, isotopic enrichment, and solvent content, supporting traceability and compliance with research and regulatory standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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