Pure Fluconazole Powder

Genbay Biotechnology Co., Ltd. provides high-grade Pure Fluconazole Powder as a pharmaceutical-grade raw material for global supply, used for the treatment of systemic and localized fungal infections. As a first-generation triazole antifungal, this compound is globally recognized for its efficacy, broad spectrum of activity, and excellent safety profile. Pure Fluconazole Powder functions by highly selective inhibition of fungal cytochrome P450-dependent enzyme lanosterol 14-alpha-demethylase. This inhibition prevents the conversion of lanosterol to ergosterol, an essential component of the fungal cell membrane, leading to membrane instability and fungal cell death. Our manufacturing process ensures an ultra-pure crystalline form with superior stability and solubility, making it the ideal active pharmaceutical ingredient (API) for the production of oral capsules, tablets, and intravenous (IV) infusions.

Specification

The following data represents the typical profile for our Pure Fluconazole Powder.

• Assay: 98.0% to 102.0% (HPLC, calculated on dried basis)
• Appearance: White to off-white crystalline powder
• Loss on Drying: ≤0.5%
• Residue on Ignition: ≤0.1%
• Heavy Metals: ≤10 ppm
• Melting Point: 137°C to 141°C

Uses

• Antifungal Therapy: The primary direct use of Pure Fluconazole Powder is as the active ingredient in medications for Candidiasis (oral, vaginal, and systemic) and Cryptococcal meningitis.
• Prophylactic Treatment: Used in the formulation of treatments for immunocompromised patients, such as those undergoing chemotherapy or bone marrow transplants, to prevent fungal infections.
• Dermatological Applications: Utilized in specialized creams or oral treatments for fungal skin infections and onychomycosis (nail fungus).
• Pharmacology Research: Used in laboratory settings to study fungal resistance mechanisms and the development of next-generation triazole derivatives.
• Formulation Development: Highly stable and suitable for the production of standard-release tablets, powder for oral suspension, and sterile IV solutions.

Quality Assurance & Certifications

Genbay produces Pure Fluconazole Powder in modern facilities that strictly adhere to international USP, EP, and GMP pharmaceutical standards.

• Testing Protocol: Every batch is subjected to rigorous analytical procedures, including HPLC for purity verification, IR for structural identity, and full microbial screening to ensure clinical safety.
• Certifications: Our production infrastructure is ISO and GMP certified, providing a reliable and transparent supply chain for pharmaceutical manufacturers worldwide.
• Documentation: We provide a comprehensive Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS) with every shipment to ensure professional transparency.

Packaging & Shipping

• Packaging: 1 kg aluminum foil bags with vacuum sealing for moisture protection or 25 kg industrial-grade fiber drums for bulk production requirements.
• Shipping: We offer secure and discreet international shipping through professional chemical logistics partners to ensure the material arrives safely and maintains its integrity.
• Storage: Pure Fluconazole Powder should be stored in a cool, dry place, protected from direct sunlight and moisture to maintain its maximum shelf life and potency.

Frequently Asked Questions(FAQ)

Q1: What is the primary mechanism of action?
A1: Pure Fluconazole Powder disrupts the synthesis of ergosterol in fungal cell membranes, which causes the membranes to leak and ultimately kills the fungus.

Q2: Is this powder soluble in water?
A2: It is slightly soluble in water but shows good solubility in alcohol and organic solvents like methanol and acetone.

Q3: What is the shelf life of the material?
A3: When stored in a cool, dry environment and kept tightly sealed, the shelf life is typically 36 to 48 months from the date of manufacture.

Q4: Do you provide batch-specific purity certificates?
A4: Yes, a detailed COA is issued for every single batch of Pure Fluconazole Powder to confirm its assay percentage and chemical profile according to USP/EP standards.

Q5: What is the typical lead time for an international order?
A5: Standard orders are processed and dispatched within 3 to 5 business days, followed by worldwide tracked delivery.

Ready to request price, stock availability, or samples of Pure Fluconazole Powder?

Email: info@genbaybio.com

WhatsApp/Telegram: +852 94249370

Contact Genbay Biotechnology Co., Ltd.