Itraconazole
Description
Itraconazole (CAS 84625-61-6), also referenced under the development code R-51211 and the brand name Sporanox, is a broad-spectrum triazole antifungal active pharmaceutical ingredient.
It targets a wide range of fungal pathogens and serves as the basis for both systemic and topical antifungal drug products across human and veterinary medicine. This versatile API is essential for modern treatments.
The material is the primary API in oral capsule and oral solution formulations indicated for systemic fungal infections, including aspergillosis, candidiasis, and onychomycosis. It is a staple in clinical settings.
Formulators working on bioavailability enhancement frequently incorporate it into amorphous solid dispersions, cyclodextrin complexes, and nanoparticle systems to address its low aqueous solubility in various applications.
In veterinary pharmaceutical manufacturing, it is used in antifungal preparations targeting dermatophyte and systemic infections in companion animals. It provides reliable efficacy for animal health products.
Generic drug manufacturers source it as a bulk API for capsule and liquid dosage form development, where particle size and polymorphic form are critical specification parameters for regulatory compliance.
The product is supplied as a white to off-white crystalline powder in bulk quantities suited to pharmaceutical manufacturing scale. It is available in pharmaceutical-grade specifications for global distribution.
Material is typically characterized by defined polymorphic form and particle size distribution relevant to downstream performance. Micronized grades are available to support enhanced dissolution strategies.
Physical Properties
| Melting Point | 166.2 °C |
| Boiling Point | 850.0±75.0 °C(Predicted) |
| Density | 1.35 g/cm³ |
| Flash Point | >110°(230°F) |
| Appearance | Off-White Crystalline Solid |
| Color | white |
| Form | White powder |
| Water Solubility | Insoluble in water. Solube in chloroform at 50 mg/ml. Slightly soluble in ethanol or methanol |
Safety & Handling (Learn More)
Trade & Regulatory
| HS Code | 2934990002 |
| UN Number | 3286 |
| ADR Class | 8 |
| Packing Group | II |
| Storage Class | 11 - Combustible Solids |
| WGK (Germany) | 3 |
Documentation
Other Names
R-51211|ITCZ|Sporanox|Sporonox|Onmel
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