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Fluconazole
Antifungal Grade | Manufacturer & Exporter from India
Fluconazole API – Antifungal Grade | Manufacturer & Exporter from India
Fluconazole is a first-generation triazole antifungal medication. As a premier Fluconazole Manufacturer, Shabbir Chemicals supplies high-purity API to global pharmaceutical markets. It is the gold standard for treating a wide range of systemic and superficial fungal infections due to its excellent bioavailability and safety profile.
Product Overview
- Synonyms: 2-(2,4-difluorophenyl)-1,3-bis(1,2,4-triazol-1-yl)propan-2-ol
- CAS No: 86386-73-4
- Code: 86386-73-4
- Grade: USP / BP / EP / IP
- Mol. Formula: : $C_{13}H_{12}F_2N_6O$
- Mol. Weight: 306.27 g/mol
- Purity (Assay): 998.0% – 102.0% (on dried basis)
Description
Fluconazole appears as a white or almost white, crystalline powder. It is a bis-triazole antifungal that works by inhibiting the fungal enzyme lanosterol 14-α-demethylase. This inhibition prevents the synthesis of ergosterol, a critical component of fungal cell membranes, leading to increased membrane permeability and the death of the fungal cell. It is highly stable and possesses a long half-life, allowing for convenient dosing schedules.
Applications
- Candidiasis: Highly effective against vaginal, oropharyngeal, and esophageal candidiasis.
- Cryptococcal Meningitis: Used in the treatment and prophylaxis of meningitis in immunocompromised patients.
- Systemic Mycoses: Treatment of urinary tract infections, peritonitis, and pneumonia caused by susceptible fungi.
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Prophylaxis:
Often prescribed for patients undergoing bone marrow transplants or chemotherapy to prevent fungal overgrowth.
Technical Specifications
| Test Item | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Slightly soluble in water; freely soluble in methanol |
| Melting Point | 137°C to 141°C |
| Loss on Drying | Not more than 0.5% |
| Residue on Ignition | Not more than 0.1% |
| Iron Content | ≤ 20 ppm |
| Individual Impurity | Not more than 0.2% |
| Total Impurities | Not more than 0.5% |
Safety & Hazard Information
- Signal Word: Warning
- Hazard Statements: * H302: Harmful if swallowed.
- H315: Causes skin irritation.
- H361: Suspected of damaging fertility or the unborn child.
- Precautionary Statements:
- P201: Obtain special instructions before use.
- P280: Wear protective gloves/clothing/eye protection.
- P308+P313: IF exposed or concerned: Get medical advice/attention.
- Handling: Avoid exposure to heat and moisture. Use appropriate localized exhaust ventilation during handling.
Packaging & Logistics
- Standard Packaging: 25 kg Fiber Drums / HDPE Drums with double-layered anti-static PE bags.
- Storage: Store at room temperature ($15^{\circ}\text{C}$ to $30^{\circ}\text{C}$). Keep away from strong oxidizing agents.
- Export Markets: Regular shipments to CIS countries, Africa, Latin America, and South East Asia.
- Regulatory Support Full documentation including COA, MOA, and Stability Data provided with every batch.
Why Source from Us?
At Shabbir Chemicals, we maintain a state-of-the-art manufacturing facility that complies with cGMP and ISO standards. Our Famotidine API undergoes rigorous quality control testing to ensure it meets the stringent pharmacopeial requirements of the global market.