Itraconazole

CAS Number
84625-61-6
EC Number
617-596-9

What is Itraconazole?

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.

Where is Itraconazole used?

  • Human medicine: basis for systemic and topical antifungal drug products
  • Oral capsule and oral solution formulations for systemic fungal infections, including aspergillosis, candidiasis, and onychomycosis
  • Bioavailability enhancement: amorphous solid dispersions, cyclodextrin complexes, and nanoparticle systems addressing low aqueous solubility
  • Veterinary medicine: antifungal preparations targeting dermatophyte and systemic infections in companion animals
  • Generic drug manufacturers source it as a bulk API for capsule and liquid dosage form development.

Good to know: Particle size and polymorphic form are critical specification parameters for regulatory compliance.

Commercial specifications

  • Defined polymorphic form and particle size distribution
  • Micronized grades for enhanced dissolution strategies

Other Names (Synonyms)

R-51211|ITCZ|Sporanox|Sporonox|Onmel

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What are the physical properties of Itraconazole?

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

How is Itraconazole classified and handled safely? Learn More

Warning
GHS07· Irritant

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.

Which trade and regulatory codes apply to Itraconazole?

HS Code 2934990002
UN Number 3286
ADR Class 8
Packing Group II
Storage Class 11 - Combustible Solids
WGK (Germany) 3
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