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Itraconazole

CAS Number
84625-61-6
EC Number
617-596-9
Chemical Formula
C35H38Cl2N8O4
Molecular Weight
705.6 g/mol

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. Contact us for supply of Itraconazole Request Quote

Other Names (Synonyms)

R-51211 | ITCZ | Sporanox | Sporonox | Onmel

Key Technical Features

  • High Purity Grade standard
  • Consistent Batch Quality
  • Full Regulatory & REACH Support
  • Global Logistics Network enabled

Physical Properties

Melting Point166.2 °C
Boiling Point850.0±75.0 °C(Predicted)
Density1.35 g/cm³
Flash Point>110°(230°F)
AppearanceOff-White Crystalline Solid
Colorwhite
FormWhite powder
Water SolubilityInsoluble in water. Solube in chloroform at 50 mg/ml. Slightly soluble in ethanol or methanol

Safety & Handling

Warning
GHS07· Irritant

Hazard Statements

H302Harmful if swallowed
H315Causes skin irritation
H319Causes serious eye irritation
H335May cause respiratory irritation

Precautionary Statements

P261Avoid breathing dust/fume/gas/mist/vapours/spray.
P264Wash … thoroughly after handling.
P270Do not eat, drink or smoke when using this product.
P271Use only outdoors or in a well-ventilated area.
P280Wear protective gloves/protective clothing/eye protection/face protection.
P319Get medical advice/attention if you feel unwell.
P321Specific treatment (see … on this label).
P330Rinse mouth.
P405Store locked up.
P501Dispose of contents/container in accordance with local regulations.
P265Wash … thoroughly after handling.
P317Get emergency medical help.
P352IF ON SKIN: Wash with plenty of water.
P340IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P317Get emergency medical help.
P317If eye irritation persists: Get medical advice/attention. Get emergency medical help.
P364Take off contaminated clothing and wash it before reuse.
P233Store in a well-ventilated place. Keep container tightly closed.
P338IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Trade & Regulatory

HS Code2934990002
UN Number3286
ADR Class8
Packing GroupII
Storage Class11 - Combustible Solids
WGK (Germany)3