Fluconazole API (CAS No. 86386-73-4)

Fluconazole (CAS No. 86386-73-4) is a triazole antifungal agent with the molecular formula C13H12F2N6O and a molecular weight of 306.271. It is a white to off-white crystalline powder, practically insoluble in water but readily soluble in glacial acetic acid, methanol, and ethanol. Its mechanism of action involves inhibiting cytochrome P450-mediated ergosterol biosynthesis in fungal cells. It is effective against deep-seated fungal infections caused by organisms such as Candida and Cryptococcus. Clinically, it is used to treat meningitis, pneumonia, recurrent vulvovaginal candidiasis (RVVC), and Malassezia folliculitis. Available dosage forms include tablets, capsules, and sodium chloride injection. Fluconazole has an oral bioavailability of approximately 90% and a low plasma protein binding rate of 11%–12%. It is primarily excreted unchanged via the kidneys. The overall response rate for RVVC treatment can reach 87.27%, while the overall response rate for Malassezia folliculitis treatment is 83%.

Fluconazole is a triazole pharmaceutical raw material with an appearance ranging from white to off-white crystalline powder. Its mechanism of action involves the selective inhibition of fungal cytochrome P450 14α-demethylase, thereby blocking ergosterol biosynthesis and disrupting fungal cell membrane integrity. It exhibits broad-spectrum antifungal activity.

We supply Fluconazole active pharmaceutical ingredient (API) featuring high HPLC purity and stringent impurity controls. Each batch undergoes comprehensive quality testing prior to release. The powder offers good flowability and is suitable for a variety of pharmaceutical formulations. We maintain sufficient stock and support sample testing, small- and large-volume orders, and international import and export operations. A Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS) can be provided with shipments to meet the procurement requirements of pharmaceutical R&D and formulation development customers.

Formulation development and formulation screening studies for oral antifungal preparations.

Laboratory-scale and pilot-scale process validation for generic drug development projects.

Fungal pharmacology and pharmacokinetic research at universities and research institutions.

Development of analytical methods, quality standards, and stability studies.

Raw material for the preparation of fungal-related impurity reference standards.

Pharmaceutical raw material import and export supply, including use in supporting custom synthesis projects.

1. Store in a tightly sealed, light-protected container in a cool, dry warehouse. Maintain the ambient temperature below 25℃ and relative humidity below 60%.

2. Keep away from heat sources, direct strong light, and strong oxidizing agents. Avoid prolonged exposure to humid conditions to prevent reductions in product purity and increases in impurity levels.

3. Small samples are packaged in sealed aluminum foil vacuum bags to prevent exposure to air and moisture and maintain sample stability.

4. Bulk products are packaged in double-layer sealed PE inner bags and 25 kg fiberboard drums as outer packaging to provide enhanced protection.

5. Customized packaging specifications are available to accommodate different procurement requirements, including sample testing, pilot-scale trials, and large-scale production.

6. Before dispatch, each drum is inspected to verify seal integrity and ensure that there is no packaging damage or powder leakage before handover to the logistics provider.

7. Transport at ambient temperature. Handle with care during loading and unloading, and protect the goods from excessive pressure, rain, and direct sunlight.

8. For export orders, additional pallet reinforcement and moisture-resistant stretch wrapping are provided to reduce the risk of damage during long-distance ocean transportation.

Our Fluconazole API offers HPLC purity of ≥99.0%, with stringent control over various impurities and consistent quality specifications across batches. Its excellent powder flowability makes it suitable for a wide range of pharmaceutical formulations.

Every batch undergoes comprehensive quality testing before release. Complete documentation, including the COA and MSDS, can be supplied with each shipment to ensure product quality traceability.

We maintain ready-to-ship inventory and can arrange dispatch on the same day once an order is confirmed, helping customers maintain their project schedules. We support sample quantities, pilot-scale requirements, and bulk orders, with powder-related specifications adjustable upon request and subject to discussion.

Reliable logistics arrangements are in place. In the event of cargo loss during transportation, we provide full compensation to minimize procurement risks.

Our professional technical team is available to address inquiries regarding product storage, formulation compatibility, and related technical matters. We also support international import and export operations, providing a one-stop raw material procurement solution for pharmaceutical R&D customers worldwide.

We have established a comprehensive after-sales support system for pharmaceutical raw materials, with order progress monitored throughout the entire fulfillment process.

All products undergo comprehensive quality testing before dispatch to ensure that the actual product specifications are consistent with the accompanying COA.

For in-stock orders, dispatch can be arranged on the same day following order confirmation to ensure timely delivery.

In the event of cargo loss during transportation, we undertake to provide full compensation to minimize procurement risks.

After receiving the goods, customers who have concerns regarding product specifications may submit relevant test data within the stipulated period. Our technical team will promptly coordinate a review and verification and work with the customer to agree on an appropriate resolution.

We also provide technical consultation on raw material storage and formulation applications. Orders are monitored throughout the process, and all after-sales inquiries are addressed promptly. Our goal is to provide domestic and international pharmaceutical R&D customers with a reliable, efficient, and hassle-free raw material procurement service.

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