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Pharmaceutical Chemistry
Fluconazole USP
Formula:
C13H12F2N6O
GOST/CAS:
CAS 86386-73-4
Fluconazole USP is a highly effective triazole antifungal agent that fully complies with the strict United States Pharmacopeia (USP) standards. The product is a white or almost white crystalline powder, odorless or with a faint characteristic odor. It exhibits a potent systemic effect by selectively inhibiting sterol synthesis in fungal cells. Due to its high purity, exceptional physicochemical stability, and proven safety profile, Fluconazole USP serves as an indispensable primary active pharmaceutical ingredient (API) for manufacturing a wide range of antifungal medications in the modern pharmaceutical industry.
Applications
Solid Dosage Form Production: Acts as the primary active pharmaceutical ingredient (API) in the manufacturing of oral capsules and tablets across various dosages (typically 50 mg, 150 mg, 200 mg) for treating systemic and localized mycoses.
Sterile Liquid Form Production: Utilized as the active component in preparing intravenous (IV) infusion solutions, widely used in hospital settings for treating severe forms of fungal infections.
Veterinary & Specialized Formulations: Applied in the production of antifungal medications for domestic pets and livestock, as well as in formulated complex therapeutic suspensions.
Key Advantages
High Purity per USP Standards: The strict control over fractional composition and the complete absence of foreign impurities ensure maximum bioavailability and stability of the final drug product.
High Specificity of Action: Effectively inhibits fungal cytochrome P450-dependent enzymes while exerting minimal impact on similar enzyme systems in the human body.
Manufacturing Versatility: The powder demonstrates excellent flowability and technological properties, simplifying encapsulation, tablet pressing, and dissolution processes for liquid forms.
Molecular Stability: The substance remains stable under standard industrial temperature fluctuations and does not undergo hydrolysis when standard pharmaceutical manufacturing protocols are maintained.
Storage & Transportation
- Store in dry, clean, light-protected warehouses in the tightly closed original manufacturer's packaging, away from heat and moisture sources.
- Recommended storage temperature: +15°C to +30°C.
- Avoid contact with strong oxidizing agents.
- Transportation is permitted by all modes of covered transport, provided that the temperature regime is strictly followed. The material belongs to the category of pharmaceutical raw materials and is transported in accordance with non-hazardous cargo regulations (unless local regulations dictate otherwise).
- Shelf Life: 3–5 years from the date of manufacture (depending on the specific manufacturer's technical specifications).
Technical Specifications
Appearance
White or almost white crystalline powder
Assay (Content)
98.0% – 102.0% (on the dried basis)
Solubility
Sparingly soluble in water, freely soluble in methanol, soluble in alcohol
Melting Point
137°C – 141°C
Loss on Drying
Not more than 0.5%
Residual Solvents
Meets USP requirements
Residue on Ignition
Not more than 0.1%
Heavy Metals
Not more than 0.002% (20 ppm)
Supply info
- Hermetically sealed fiber drums with a double inner polyethylene liner — 25 kg.
- Small-scale packaging for laboratory trials and pilot-plant testing — 1 kg / 5 kg (upon request/agreement).