Ketoconazole (CAS No. 65277-42-1), chemically named cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine, has the molecular formula C26H28Cl2N4O4. It is a broad-spectrum imidazole antifungal agent. Its mechanism of action involves inhibiting ergosterol biosynthesis in fungal cell membranes, thereby altering membrane permeability and inhibiting fungal growth. Ketoconazole is used to treat superficial and systemic fungal infections, including skin and nail fungal infections, vaginal candidiasis, and gastrointestinal fungal infections. It is also active against systemic infections caused by organisms such as Candida albicans, Coccidioides species, and Histoplasma species.
Product Description and Specifications
Ketoconazole is a synthetic imidazole-based pharmaceutical raw material. It appears as a white to off-white crystalline powder and is a broad-spectrum antifungal active pharmaceutical ingredient (API). By inhibiting ergosterol biosynthesis, it disrupts fungal cell membrane structure and exhibits inhibitory activity against a wide range of fungi and yeasts.
We supply Ketoconazole API with consistent batch-to-batch quality, high HPLC purity, stringent impurity controls, and comprehensive analytical documentation. The product is suitable for topical formulation development, personal care and cleansing product formulation research, and laboratory research applications. Adequate stock is available to support both small- and large-volume orders, as well as import and export business.
| English Name | Ketoconazole |
| CAS No. | 65277-42-1 |
| Molecular Formula | C₂₆H₂₈Cl₂N₄O₄ |
| Molecular Weight | 531.43 |
| Appearance | White to off-white crystalline powder |
| Melting Point | 148–152℃ |
| Boiling Point | 753.4℃ (predicted, 760 mmHg) |
| Solubility | Practically insoluble in water; soluble in methanol and DMSO; slightly soluble in ethanol |
| LogP | 4.35 |
| Purity (HPLC) | ≥99.0% |
| Water Content | ≤0.5% |
| Maximum Single Impurity | ≤0.10% |
| Total Impurities | ≤0.50% |
| Residue on Ignition | ≤0.10% |
| Heavy Metals | ≤10ppm |
| Identification | IR spectrum, mass spectrometry, and HPLC retention time comparison with a reference standard |
| Storage Conditions | Store tightly sealed and protected from light in a cool, dry place. Refrigerated storage at 2–8℃ is recommended. Keep away from high temperatures and intense light. |
| Shelf Life | 24 months when stored in the original, properly sealed packaging. |
| Packaging | Aluminum foil bags for samples; 1kg aluminum foil bags for bulk quantities; 25kg fiber drums lined with double-layer PE bags. Customized packaging is available. |
Product Applications
1. Formulation development and screening of topical antifungal preparations.
2. Laboratory-scale and pilot-scale process validation studies for generic drug development projects.
3. Fungal pharmacology-related experiments conducted by research institutes and universities.
4. Establishment of pharmaceutical quality standards and validation of analytical methods.
5. Use as a starting material for the preparation of fungal-related impurity reference standards.
6. Pharmaceutical testing projects, including stability studies and accelerated aging studies.
7. Formulation development and compatibility studies for antimicrobial ingredients used in personal care and cleansing products.
8. Custom synthesis of pharmaceutical intermediates and supply of raw materials for import and export.
Storage, Packaging and Transportation
This product must be stored in a tightly sealed container, protected from light, in a cool, dry warehouse. The recommended storage temperature is 2–8℃, with relative humidity maintained at no more than 60%. Keep away from intense light, heat sources, and oxidizing agents. Avoid prolonged exposure to moisture, which may adversely affect product quality and specification compliance.
Samples are packaged in vacuum-sealed aluminum foil bags. Bulk quantities are supplied in aluminum foil inner packaging, enclosed in 25kg fiber drums lined with double-layer PE bags. Customized packaging specifications are available according to customer requirements.
All packaging is inspected for proper sealing before dispatch, and appropriate moisture-protection measures are implemented. The product is transported through standard ambient-temperature logistics channels. Handle with care during loading and unloading to prevent packaging damage.
For export orders shipped by sea, additional moisture-resistant pallets and stretch-film wrapping are used to reinforce the packaging. Exposure to rain and direct sunlight is avoided throughout transportation.
The product has a shelf life of up to 24 months when kept in its original, intact packaging and stored under the specified conditions.
Product Advantages
Our Ketoconazole API offers an HPLC purity of ≥99.0%, with strictly controlled impurity specifications and excellent batch-to-batch consistency. Every batch undergoes comprehensive quality testing before release. A complete set of supporting documentation, including a Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS), can be provided with each shipment to ensure product traceability.
We maintain sufficient inventory to support prompt fulfillment, with same-day dispatch available upon order confirmation for in-stock products, helping customers maintain their research and development schedules.
We support both small- and large-volume purchases. Powder particle size can be adjusted according to customer requirements to accommodate different formulation systems.
Comprehensive logistics support is available. In the event of cargo loss during transportation, we provide full compensation, helping to minimize procurement risks.
Our professional technical team provides consultation and support, addressing customer inquiries regarding storage, compatibility, and related technical matters. We also support global import and export operations, offering a one-stop raw material procurement solution for customers in domestic and international markets.
After-Sales Support and Quality Assurance
We have established a comprehensive after-sales support system for pharmaceutical raw materials and provide continuous follow-up throughout the entire order process.
All products undergo rigorous quality inspections before dispatch to ensure that the actual product specifications are consistent with the corresponding COA test report.
For in-stock orders, dispatch is arranged on the same day after order confirmation to improve delivery efficiency. In the event of cargo loss during transportation, we guarantee full compensation to help minimize procurement risks.
If customers have any concerns regarding product test results or specifications after receipt, they may submit the relevant analytical data within the agreed period. Our technical team will promptly coordinate a review, conduct verification, and provide an appropriate solution.
We also provide technical consultation on raw material storage and formulation applications.
We maintain continuous oversight of the entire order process and respond promptly to all after-sales inquiries and issues, providing domestic and international pharmaceutical R&D customers with a reliable and consistent raw material procurement experience.
Hot Tags: high-quality ketoconazole api, China high-quality ketoconazole api manufacturers, suppliers, factory
