General Information
- Product Name: Itraconazole
- Molecular Formula: C35H38Cl2N8O4
- Molecular Weight: 705.64 g/mol
- CAS Number: 84625-61-6

Physical and Chemical Characteristics
- Appearance: White or slightly yellowish crystalline powder
- Solubility: Insoluble in water, slightly soluble in ethanol and methanol
- Melting Point: 166-170°C
- pH Value: 2.0-4.0 (1% aqueous solution)

Specifications
- Assay: ≥98.0%
- Moisture: ≤5.0%
- Heavy Metals: ≤10 ppm
- Residue on Ignition: ≤0.1%
- Microbial Limit: ≤100 CFU/g

Stability and Storage
- Stability: Stable for at least 2 years from the date of manufacture when stored properly
- Storage: Store in a cool, dry place, away from direct sunlight and moisture

Handling and Safety
- Handling: Handle with care, as the product may be irritating to skin and eyes
- Safety: Wear protective gloves, safety glasses, and a dust mask when handling the product
- Disposal: Dispose of the product according to local regulations and guidelines

Regulatory Compliance
- USP: Compliant with USP standards
- EP: Compliant with European Pharmacopoeia standards
- ISO: Compliant with International Organization for Standardization (ISO) standards

Packaging
- Packaging Size: 1g
- Packaging Material: Glass bottles or containers with tight-fitting lids
- Labeling: Product name, batch number, and expiration date

Applications
- Pharmaceuticals: Used as an antifungal agent in the treatment of various fungal infections
- Veterinary Medicine: Used as an antifungal agent in veterinary medicine to treat fungal infections in animals
- Research and Development: Used as a reference standard in research and development applications