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Fluconazole is a triazole antifungal agent widely used for the treatment and prevention of systemic and superficial fungal infections, including candidiasis, cryptococcal meningitis, and dermatophytic infections. It works by inhibiting the fungal cytochrome P450 enzyme 14α-demethylase, disrupting ergosterol synthesis, an essential component of the fungal cell membrane, thereby impairing fungal growth.
Bluepill Express manufactures high-purity Fluconazole API in compliance with WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring consistent quality, stability, and pharmacopeial compliance for global pharmaceutical formulations. Our Fluconazole API is suitable for oral tablets, capsules, and intravenous formulations.
Therapeutic Uses
- Systemic fungal infections: Candidemia, cryptococcal meningitis
- Vaginal and oral candidiasis
- Dermatophytic infections: Ringworm, tinea infections
- Prophylactic use: Prevention of fungal infections in immunocompromised patients
- Combination therapy: Used alongside other antifungal or antibacterial agents
Mechanism of Action
Fluconazole inhibits fungal cytochrome P450 14α-demethylase, preventing the conversion of lanosterol to ergosterol, a vital component of the fungal cell membrane. This inhibition disrupts membrane integrity, leading to fungistatic effects and inhibition of fungal growth. Its high oral bioavailability and CNS penetration make it effective for systemic and mucosal infections.
Pharmacological Information
- Chemical Name: 2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol
- Molecular Formula: C13H12F2N6O
- Molecular Weight: 306.27 g/mol
- CAS Number: 86386-73-4
- Therapeutic Class: Antifungal Agent
- Pharmacological Class: Triazole Derivative
- ATC Code: J02AC01
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Soluble in water, methanol, ethanol; slightly soluble in chloroform |
| Melting Point | 137°C – 140°C |
| pH (1% aqueous solution) | 5.0 – 7.0 |
| Storage | Store below 25°C in a dry, ventilated area, protected from light |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, and HPLC positive |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.5% (individual impurity) |
| Bulk Density | 0.40 – 0.55 g/mL |
| Tapped Density | 0.55 – 0.70 g/mL |
Applications
Fluconazole API is used in:
- Oral tablets and capsules for systemic and topical fungal infections
- Intravenous formulations for severe systemic infections
- Prophylactic antifungal therapies for immunocompromised patients
- Combination antifungal therapy in resistant infections
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Method of Analysis (MOA)
- Stability Data (ICH-compliant)
- Regulatory Dossier / DMF (on request)
Packaging & Export Details
- Available Packs: 1 kg | 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Product name, batch number, manufacturing/expiry date, storage instructions
- Shelf Life: 36 months under recommended storage conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
