Butoconazole Nitrate is a pivotal antifungal API and certified reference standard used extensively in the treatment of vulvovaginal candidiasis. As an imidazole antifungal agent, Butoconazole Nitrate inhibits the biosynthesis of ergosterol, a critical component of fungal cell membranes, leading to growth inhibition and cell death . In quality control and pharmaceutical development contexts, Butoconazole Nitrate reference standards are essential for analytical method development, method validation, quality control testing, and regulatory submissions. With its broad antifungal spectrum and established clinical efficacy, Butoconazole Nitrate has been formulated in various topical products for the treatment of fungal infections caused by Candida species . The high-purity nitrate salt form ensures consistent pharmaceutical performance and stability.
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Parameter |
Specification |
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Product Name |
Butoconazole Nitrate |
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CAS Number |
64872-77-1 |
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Molecular Formula |
C₁₉H₁₇Cl₃N₂S·HNO₃ |
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Molecular Weight |
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Appearance |
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Melting Point |
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Solubility |
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Storage Condition |
Room temperature, cool and dark place (<15°C) |
The antimicrobial spectrum of butoconazole nitrate is similar to that of other imidazole compounds. It has antibacterial activity against Gram-positive bacteria, no activity against Gram-negative bacteria, and good antibacterial activity against Aspergillus fungi and Candida. It has an inhibitory effect on Candida, Trichophyton, Microsporum and Epidermophyton in vitro, and also has a certain inhibitory effect on some Gram-positive bacteria. It is highly effective in clinical treatment of vaginal infections caused by Candida albicans, Candida tropicalis, etc. Studies on mouse models of Candida albicans infection have shown that the in vivo antifungal activity of butoconazole nitrate is better than that of miconazole solution (trade name: Daktarin), 1% clotrimazole (trade name: Canesten) and 100,000 U•g⁻¹ nystatin (trade name: Mycostatin). Dose-effect experiments show that 0.25% butoconazole has similar pharmacological activity to 4% miconazole.
Butoconazole nitrate (RS-35887) is an antifungal agent that inhibits the secretion of cytokines (such as IL-2, TNFα, IFN and GM-CSF) in human peripheral blood lymphocytes stimulated by PHA, with IC50 values of 7.2 μg/mL, 14.4 μg/mL, 7.36 μg/mL and 7.6 μg/mL, respectively.
Imidazoles generally inhibit the conversion of lanosterol to ergosterol, leading to changes in the lipid composition of the fungal cell membrane. Such structural changes alter the permeability of the cell, ultimately resulting in osmotic damage or growth inhibition of the fungal cell.
Securing Butoconazole Nitrate for your antifungal therapeutic development program or analytical method validation should be straightforward. Cosperpharm makes it simple. Reach out today to discuss your specifications.
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