General Information

Ethinylestradiol Impurities and Ethinylestradiol

Daicel Pharma offers high-quality impurities for Ethinylestradiol, an active pharmaceutical ingredient. These impurities, including Ethinyl estradiol Impurity H, Ethinyl Estradiol EP Impurity F, Ethinyl estradiol Impurity, Ethinyl estradiol Impurity I, Ethinyl Estradiol Impurity-K, Ethinyl Estradiol Impurity M, Ethinylestradiol Impurity Dimer and so on, play a vital role in assessing the purity, reliability, and safety of Ethinylestradiol. Daicel Pharma also offers a customized synthesis of Ethinylestradiol impurities to cater to client requirements, with worldwide delivery options available.

Ethinyl estradiol [CAS: 57-63-6] is a semisynthetic estrogen. It is a modified form of estradiol with a 17-alpha-Ethinyl substitution. It exhibits high estrogenic potency and is the estrogen component in oral contraceptives. Additionally, Ethinyl estradiol may delay the progress of prostate cancer.

Ethinylestradiol: Use and Commercial Availability  

Ethinyl estradiol, a synthetic estrogen, is widely available under various brand names such as Alesse, Tri-Cyclen, Triphasil, etc., as a combination oral contraceptive. When combined with a progestogen, Ethinyl estradiol is used as an oral contraceptive to prevent pregnancy, with FDA approval. It also protects against osteoporosis and may delay the progress of prostate cancer.

Ethinylestradiol Structure and Mechanism of Action

The chemical name of Ethinylestradiol is (17α)-19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol. Its chemical formula is C₂₀H₂₄O₂, and its molecular weight is approximately 296.4 g/mol.

Ethinylestradiol acts by binding to the estrogen receptor complex and entering the nucleus. It triggers the activation of DNA transcription, leading to gene expression in estrogenic cellular responses. It inhibits 5-alpha reductase in epididymal tissue, lowers testosterone levels, and delays the progress of prostate cancer.

Ethinylestradiol Impurities and Synthesis

Impurities in Ethinylestradiol are unintended substances or byproducts that can be present in the medication. They can emerge during the synthesis¹, manufacturing, or storage processes. They may include related compounds, degradation products, residual solvents, or other impurities introduced during synthesis or handling. The presence of impurities can impact Ethinylestradiol quality, stability, and effectiveness. Strict regulatory guidelines and quality control measures help monitor and control the levels of impurities in Ethinylestradiol.

Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Ethinylestradiol impurity standards, including Ethinyl estradiol Impurity H, Ethinyl Estradiol EP Impurity F, Ethinyl estradiol Impurity, Ethinyl estradiol Impurity I, Ethinyl Estradiol Impurity-K, Ethinyl Estradiol Impurity M, Ethinylestradiol Impurity Dimer and so on. These impurities are produced by an analytical facility that complies with cGMP standards. The CoA provides a detailed characterization report with data obtained through techniques such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². We give additional data like 13C-DEPT upon request. Daicel Pharma synthesizes unknown Ethinylestradiol impurities or degradation products. Every delivery has a complete characterization report.