Clascoterone
General Information
Clascoterone Impurities and Clascoterone
Daicel Pharma is a reliable source in synthesizing excellent-quality Clascoterone impurities and isotope-labeled standards. They are vital for evaluating the quality, stability, and biological safety of Clascoterone. Furthermore, Daicel Pharma specializes in the custom synthesis of Clascoterone impurities and ensures their global delivery.
Clascoterone [CAS: 19608-29-8] is an androgen receptor inhibitor. Androgen receptors is a steroid nuclear receptor. It blocks the binding of dihydrotestosterone and reduces androgen influence on sebaceous glands1. Further, it lowers sebum production and acne formation.
Clascoterone: Use and Commercial Availability
Clascoterone is available as Winlevi, a topical cream. It treats acne vulgaris in patients who are twelve years or older. It is a part of the alopecia treatment. Because of its anti-inflammatory properties, Clascoterone can reduce the severity of acne in patients.
Clascoterone Structure and Mechanism of Action
The chemical name of Clascoterone is 21-Hydroxy-17-(1-oxopropoxy)pregn-4-ene-3,20-dione. The chemical formula for Clascoterone is C24H34O5, and its molecular weight is approximately 402.52 g/mol.
Clascoterone inhibits androgen receptor. However, its mechanism of action is not known.
Clascoterone Impurities and Synthesis
During Clascoterone synthesis2, impurities form that may affect the safety and efficacy of the drug. They form during the synthetic process, purification, or storage of Clascoterone. Clascoterone impurities must be controlled and monitored throughout the drug development process.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Clascoterone impurities and isotope-labeled standards. Daicel Pharma offers CoA from a cGMP-compliant analytical facility. It provides complete characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. We give additional analytical data on request. Daicel Pharma can prepare any unidentified Clascoterone impurity or degradation product. In addition, Daicel Pharma offers a highly purified, stable deuterium-labeled standard of Clascoterone D6. The clients of Daicel Pharma can expect a complete characterization report on delivery.
References
FAQ's
References
- Drugs, 2020 Nov;80(16):1745-1750, DOI: (1007/s40265-020-01417-6)
- Ajani, Mauro; Moro, Luigi, 17alfa, 21-dihydroxypregnene esters as antiandrogenic agents, WO03014141A1, Feb 20. 2003, Cosmo S.P.A., Italy (https://patents.google.com/patent/WO2003014141A1/zh)
Frequently Asked Questions
2. How do the degradation products form in Clascoterone drug product?
Light, heat, humidity, and hydrolysis are responsible for the degradation of Clascoterone.
3. Why is it necessary to eliminate nitrosamine impurities from Clascoterone?
Nitrosamine impurities are carcinogenic and affect drug safety. So, it is necessary to remove nitrosamine impurities from Clascoterone.
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