Cortexolone
General Information
Cortexolone Impurities and Cortexolone
Daicel Pharma offers high-quality Cortexolone impurities such as Cortexolone 21-propionate. It is vital for evaluating Cortexolone’s quality, stability, and biological safety. Furthermore, Daicel Pharma specializes in the custom synthesis of Cortexolone impurities and ensures their worldwide delivery.
17,21-Dihydroxypregn-4-ene-3,20-dione, known as cortexolone [CAS: 152-58-9], is a 17-hydroxycorticosteroid exhibiting glucocorticoid and anti-inflammatory properties. It serves as an intermediate in the biosynthesis of cortisol in the adrenal gland.
Cortexolone: Use and Commercial Availability
Cortexolone is a derivative of cortisol, a topical androgen antagonist that treats acne. It functions as a metabolite in both mice and humans. Cortexolone is classified as a glucocorticoid and falls into categories including primary alpha-hydroxy ketones, tertiary alpha-hydroxy ketones, and deoxycortisol.
Cortexolone Structure and Mechanism of Action
Cortexolone is also known as 11-Deoxycortisol. The chemical formula for Cortexolone is C21H30O4, and its molecular weight is approximately 346.5g/mol.
The exact mechanism of action of Cortexolone is not known.
Cortexolone Impurities and Synthesis
While synthesizing Cortexolone, care is crucial to maintain the drug’s purity and efficacy. Despite these efforts, impurities can emerge, potentially impacting the drug’s quality. Sophisticated purification techniques such as chromatography and crystallization can minimize impurities. Continuous monitoring and adherence to stringent quality standards are essential in Cortexolone synthesis.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Cortexolone impurities, such as Cortexolone 21-propionate. The CoA is from a cGMP-compliant analytical facility and encompasses complete characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC2 purity. On request, we give additional data like 13C-DEPT and CHN. Daicel Pharma prepares any unidentified Cortexolone impurity or degradation product. Furthermore, Daicel Pharma offers highly purified isotope-labeled standards of Cortexolone for bioanalytical research and BA/BE studies. We provide a complete characterization report upon delivery.
References
- Hartmann, Fred; Ilner, Wolfgang R., Quantitative estimation of unconjugated cortisol, cortisone, corticosterone, cortexone, and cortexolone by thin-layer chromatography, Research in Experimental Medicine, Volume: 161, Issue: 2, Pages: 165-74, 1973, DOI: (10.1007/BF01855109)
- Carson, Stanley W.; Jusko, William J., Simultaneous analysis of cortexolone and cortisol by high-performance liquid chromatography for use in the metyrapone test, Journal of Chromatography, Biomedical Applications, Volume: 306, Pages: 345-50, 1984, DOI: (10.1016/s0378-4347(00)80897-x)
Frequently Asked Questions
How are impurities detected in Cortexolone?
Impurities in Cortexolone can be detected using various analytical techniques such as HPLC.
What is the impact of impurities on the stability of Cortexolone?
Impurities can affect the stability of Cortexolone, leading to a decrease in its shelf life.
Are there specific methods available for removing Cortexolone impurities from the drug?
Purification methods such as recrystallization, chromatography, and distillation can remove Cortexolone impurities from the drug.
Are there regulatory guidelines for controlling Cortexolone impurities from the drug?
Regulatory agencies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) provide guidelines for controlling impurities in pharmaceutical products, including Cortexolone.
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