What is Fluconazole Powder?
Fluconazole Powder is a triazole antifungal active pharmaceutical ingredient (API) widely used in the pharmaceutical industry for the manufacture of antifungal medications. It inhibits fungal growth by blocking ergosterol synthesis, an essential component of fungal cell membranes, providing effective treatment against Candida, Cryptococcus, and other susceptible fungal pathogens.
Technical Specifications
|
Item |
Specification |
|
Product Name |
Fluconazole Powder |
|
Appearance |
White Powder |
|
Assay |
≥99.0% (HPLC) |
|
CAS No. |
86386-73-4 |
|
Molecular Formula |
C₁₃H₁₂F₂N₆O |
|
Molecular Weight |
306.27 g/mol |
|
Dosage Forms |
Tablets, Capsules, Injections, Suspensions, Topical Preparations |
|
Packaging |
1 kg aluminum foil bag, 5 kg aluminum foil bag, 25 kg fiber drum (vacuum packed optional) |
|
Shelf Life |
2 Years under recommended storage conditions |
|
Storage |
Store in a cool, dry place away from direct sunlight |
|
Grade |
Pharmaceutical Grade |
|
Test Standard |
USP / EP / BP / CP (available upon request) |
|
Supply Ability |
Bulk Supply & OEM Support |
|
Application |
Pharmaceutical Active Pharmaceutical Ingredient (API) |
|
MOQ |
1 kg (sample available) |
|
Lead Time |
Normally 3–15 working days depending on order quantity |
|
For Research Use |
Research use only unless otherwise agreed |
Advantages of Fluconazole Powder
Broad-Spectrum Antifungal Activity
Demonstrates excellent activity against Candida species, Cryptococcus neoformans, and various pathogenic fungi commonly responsible for systemic and superficial fungal infections.
Excellent Formulation Compatibility
Compatible with multiple pharmaceutical dosage forms including tablets, capsules, oral suspensions, injectable solutions, and topical preparations, allowing flexible formulation development.
Applications of Fluconazole Powder
Fluconazole Powder is primarily used as an active pharmaceutical ingredient in the development and manufacture of antifungal medicines across multiple dosage forms.
Oral Tablets & Capsules
Used for treating vulvovaginal candidiasis, oropharyngeal candidiasis, esophageal candidiasis, and other systemic fungal infections through convenient oral administration.
Injectable Formulations
Applied in intravenous antifungal therapies for hospitalized patients with severe systemic fungal infections or immunocompromised conditions.
Topical Pharmaceutical Products
Can be incorporated into creams, gels, and other topical preparations for localized fungal infections when appropriate formulation strategies are employed.
Research & Pharmaceutical Development
Widely utilized by pharmaceutical companies, research institutes, and formulation laboratories for process development, analytical validation, and new dosage form research.
Quality Control
Every production batch undergoes comprehensive quality testing before release. Our quality management system combines GMP manufacturing requirements with ISO 9001:2015 procedures to ensure product consistency and traceability.
Routine quality testing includes:
- Appearance identification and visual inspection
- Assay determination by validated HPLC methods
- Related substances and impurity profile analysis
- Loss on drying and moisture determination
- Residual solvent testing according to ICH guidelines
- Heavy metal analysis
- Packaging integrity inspection
- Batch record review and full product traceability
Supporting documents including COA, MSDS, TDS, and other quality documents are available upon request.
OEM & Custom Manufacturing Services
Besides bulk API supply, Xi'an Ruichi Biotech provides flexible customization services for pharmaceutical partners.
Customization options include:
- Customized packaging sizes from laboratory samples to commercial bulk quantities
- Vacuum packaging or standard export packaging
- Private labeling and customized carton labeling
- Product coding and batch identification
Documentation support including COA, MSDS, TDS, and quality certificates
Flexible shipment arrangements according to customer purchasing plans
Packaging & Shipping
Fluconazole Powder is packed in moisture-proof aluminum foil bags for small quantities and high-strength fiber drums for bulk orders. Vacuum packaging is available upon request to enhance product stability during long-distance transportation. Shipments can be arranged by DHL, FedEx, UPS, EMS, TNT, air freight, or sea freight according to destination, quantity, and delivery requirements.
FAQ
Q: What is your minimum order quantity (MOQ)?
A: Sample quantities are available, while the standard MOQ for commercial orders starts from 1 kg.
Q: What payment methods do you accept?
A: We generally accept T/T (bank transfer), with other payment methods available upon mutual agreement.
Q: Which trade terms do you support?
A: EXW, FOB, CIF, CFR, DDP, and other Incoterms can be arranged according to customer requirements.
Q: What is your normal lead time?
A: Most orders are shipped within 3–15 working days depending on quantity and production schedule.
Q: How do you ensure product quality?
A: Every batch undergoes comprehensive quality testing and is supplied with a Certificate of Analysis (COA) before shipment.
Q: Which quality documents can you provide?
A: COA, MSDS, TDS, product specifications, and other technical documents are available upon request.
Q: What packaging options are available?
A: Standard packaging includes aluminum foil bags and fiber drums, with vacuum packaging and customized labeling available.
Q: Which certifications does your company hold?
A: Our manufacturing system operates under GMP requirements and ISO 9001:2015 quality management certification, and we are an FDA-registered manufacturer.
Q: Can you provide OEM or customized services?
A: Yes, we support customized packaging, private labeling, documentation, and other OEM requirements for bulk customers.
Q: How is the product transported internationally?
A: Products can be shipped by express courier, air freight, or sea freight based on destination, order volume, and delivery schedule.
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