General Information

Etonogestrel Impurities and Etonogestrel

Daicel Pharma offers high-quality impurities for Etonogestrel, an active pharmaceutical ingredient. These impurities, including 6α-hydroxy peroxide etonogestrel and 6β-hydroxy peroxide etonogestrel, play a vital role in assessing the purity, reliability, and safety of Etonogestrel. Daicel Pharma also offers a customized synthesis of Etonogestrel impurities to cater to client requirements, with worldwide delivery options available.

Etonogestrel [CAS: 54048-10-1] is a synthetic progestin derived from progesterone, a natural hormone in females. It is a 17-beta-hydroxy steroid and a 3-oxo-Delta (4) steroid. Etonogestrel acts as a contraceptive drug for females.

Etonogestrel: Use and Commercial Availability  

Etonogestrel is available under various brand names, including Implanon and Nexplanon. It is administered through subdermal implants, offering long-acting reversible contraception. These implants are effective for up to 5 years in postpartum women, including breastfeeding women. Etonogestrel is a chief component of these contraceptive implants, providing a reliable method of preventing pregnancy.

Etonogestrel Structure and Mechanism of Action

The chemical name of Etonogestrel is (17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one. Its chemical formula is C₂₂H₂₈O₂, and its molecular weight is approximately 324.5 g/mol.

Etonogestrel suppresses ovulation and increases cervical mucus viscosity and endometrium alterations.

Etonogestrel Impurities and Synthesis

Impurities in Etonogestrel are unintended substances or contaminants that can be present in the medication. These impurities can occur during the manufacturing¹, synthesis, or storage processes. They may include related compounds, degradation products, residual solvents, or other impurities introduced during production. The impurities can affect the purity, stability, and overall quality of Etonogestrel. Strict regulatory guidelines and quality control measures help monitor and limit the levels of impurities to ensure the safety and efficacy of Etonogestrel medications.

Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Etonogestrel impurity standards, including 6α-hydroxy peroxide etonogestrel and 6β-Hydroxy peroxide etonogestrel. They generate from 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 Etonogestrel impurities or degradation products. Every delivery has a complete characterization report.