Ketoconazole | GMP-Certified Antifungal API for Topical & Oral Use 💊🦠
USP/EP-Compliant Broad-Spectrum Antimycotic with ≥99% Purity
📌 Product Overview
Ketoconazole is a potent imidazole-class antifungal agent widely used to treat systemic and superficial fungal infections12. It inhibits fungal ergosterol synthesis via CYP3A4 and CYP24A1 enzyme suppression, effectively targeting Candida, Aspergillus, and dermatophytes34. Suitable for topical creams, oral tablets, and shampoos, it addresses infections ranging from athlete’s foot to systemic candidiasis12.
✅ Key Advantages
| 🔥 Feature | 📈 Specification/Effect |
|---|
| ≥99% HPLC Purity | Verified via USP/EP monographs24 |
| Broad Antifungal Spectrum | Targets 15+ fungal strains13 |
| Stability & Solubility | 3-year shelf life (-20°C); soluble in ethanol (7 mg/mL) & DMSO (3 mg/mL)12 |
| Non-GMO & Halal Options | Adaptable for global regulatory compliance25 |
🌍 Applications
- Pharmaceuticals
: Oral antifungals, topical creams, and medicated shampoos12.
- Research
: CYP enzyme inhibition studies and antifungal mechanism research34.
- Chemical Intermediates
: Synthesis of advanced antifungal compounds26.
- Cosmetics
: Antidandruff formulations and skincare products15.
📜 Quality Certifications
- GMP/ISO 9001
: Produced under WHO-aligned quality systems24.
- USP/EP Compliance
: Rigorous testing via HPLC, GC-MS, and microbial limits24.
- Residual Solvents
: ≤10 ppm (ICH Q3C compliant)24.
📈 Market Trends
The global antifungal API market is projected to reach $9.2B by 2030, driven by rising fungal resistance and demand for cost-effective treatments25. Dermatology applications dominate 40% of antifungal consumption, emphasizing Ketoconazole’s role in skincare and infection control12.
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