Beclomethasone
General Information
Beclomethasone Impurities and Beclomethasone
Daicel Pharma offers the best-quality Beclomethasone impurities, such as Beclomethasone EP impurity F. It is vital to evaluate Beclomethasone quality, stability, and biological safety. Furthermore, Daicel Pharma specializes in the custom synthesis of Beclomethasone impurities and ensures their worldwide delivery.
Beclomethasone [CAS: 4419-39-0] is a synthetic corticosteroid medicine that has anti-inflammatory properties. It treats asthma and allergic rhinitis, seasonal and perennial. It has immunomodulating properties. The Glaxo Group in the UK first developed Beclomethasone as a metered dose inhaler.
Beclomethasone: Use and Commercial Availability
Beclomethasone was US FDA-approved to treat asthma as a nasal spray. It is for maintenance treatment of asthma as prevention therapy. In addition, it treats skin infections such as dermatitis, psoriasis, eczema, and allergies. It treats ulcerative colitis. It is available as an oral inhaler, topical cream, and other formulations. Many generic manufacturers prepare Beclomethasone under various brands like Beclovent, Beconase, Qnasl, Vancenase, Vanceril, and more.
Beclomethasone Structure and Mechanism of Action
The chemical name of Beclomethasone is 9-Chloro-11β,17,21-trihydroxy-16β-methyl-pregna-1,4-diene-3,20-dione. Beclomethasone’s chemical formula is C22H29ClO5, and its molecular weight is approximately 408.92 g/mol.
Beclomethasone is a prodrug that converts to its active metabolite, beclomethasone-17-monopropionate. The exact mechanism of action of Beclomethasone is not known.
Beclomethasone Impurities and Synthesis
When synthesizing Beclomethasone, impurities form that may affect the safety and efficacy of the drug. These impurities form during the synthetic process, purification, and storage of Beclomethasone. As a result, Beclomethasone impurities must be controlled and monitored throughout the drug development process.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Beclomethasone impurities, which includes Beclomethasone EP impurity F. A cGMP-compliant analytical facility furnishes the CoA. It provides complete characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity1,2. We give additional spectral data on request. Daicel Pharma can prepare any unidentified Beclomethasone impurity or degradation product. In addition, Daicel Pharma offers highly purified stable isotope-labeled standards of Beclomethasone for bioanalytical research and BA/BE studies. Customers can expect a complete characterization report on delivery.
References
- Stanley, S. M. R.; Wilhelmi, B. S.; Rodger, J. P.; Guthrie, A., Detection of corticosteroids by high-performance liquid chromatography/negative ion chemical ionization mass spectrometry using a particle beam interface, Biological Mass Spectrometry, Volume: 23, Issue: 8, Pages: 483-91, 1994 DOI: (1002/bms.1200230805)
- Fu, Qiang; Shou, Minshan; Chien, Dwight; Markovich, Robert; Rustum, Abu M., Development and validation of a stability-indicating RP-HPLC method for assay of betamethasone and estimation of its related compounds, Journal of Pharmaceutical and Biomedical Analysis, Volume: 51, Issue: 3, Pages: 617-625, 2010 DOI: (10.1016/j.jpba.2009.09.034)
Frequently Asked Questions
2.How do we characterize the unknown impurities of Beclomethasone?
Analytical methods like HPLC, 1H NMR, 13C NMR, and MS characterize the unknown impurities of Beclomethasone.
3.How do Beclomethasone impurities form in the drug substance?
Beclomethasone impurities form from unreacted starting materials, by-products, intermediates, reagents, ligands, heavy metals, inorganic salts, and residual solvents.
4.Why is it essential to study the impurities in Beclomethasone?
Impurities in Beclomethasone will affect the drug’s quality, safety, and stability.
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