Overview
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.
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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
Warning GHS07 Hazard Statements H302 Harmful if swallowed H315 Causes skin irritation H319 Causes serious eye irritation H335 May cause respiratory irritation Precautionary Statements P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P264 Wash … thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P271 Use only outdoors or in a well-ventilated area. P280 Wear protective gloves/protective clothing/eye protection/face protection. P319 Get medical advice/attention if you feel unwell. P321 Specific treatment (see … on this label). P330 Rinse mouth. P405 Store locked up. P501 Dispose of contents/container in accordance with local regulations. P264+P265 Wash … thoroughly after handling. P301+P317 Get emergency medical help. P302+P352 IF ON SKIN: Wash with plenty of water. P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P332+P317 Get emergency medical help. P337+P317 If eye irritation persists: Get medical advice/attention. Get emergency medical help. P362+P364 Take off contaminated clothing and wash it before reuse. P403+P233 Store in a well-ventilated place. Keep container tightly closed. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Trade & Regulatory
| HS Code | 2934990002 |
| UN Number | 3286 |
| ADR Class | 8 |
| Packing Group | II |
| Storage Class | 11 - Combustible Solids |
| WGK (Germany) | 3 |
Other Names
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Chemical Properties
- CAS Number
- 84625-61-6
- EC Number
- 617-596-9
- Mol. Weight
- 705.6
- HS Code
- 2934990002
- Category
- Heterocyclic Compounds