Description

Fluconazole (Hydrate) is a high-purity synthetic antifungal agent belonging to the triazole class. It is a critical active pharmaceutical ingredient (API) valued for its broad-spectrum efficacy and favorable pharmacokinetic profile. This compound is essential for manufacturers in the pharmaceutical industry developing systemic antifungal treatments for both human and veterinary medicine.

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in the formulation of oral tablets, capsules, and intravenous solutions.
• Manufacturing of generic antifungal medications for the treatment of candidiasis, cryptococcal meningitis, and other systemic fungal infections.
• Key component in veterinary pharmaceuticals for treating fungal diseases in animals.
• Used in clinical research and reference standard preparation for analytical laboratories.
• Intermediate in the synthesis of more complex antifungal agents and related chemical derivatives.
• Potential applications in the development of antifungal coatings or preservatives for specialized industrial materials.

Basic Information

Product Name	Fluconazole (Hydrate)
CAS No.	155347-36-7
Molecular Formula	C13H12F2N6O · xH2O
Molecular Weight	306.27 g/mol (Anhydrous basis)
Synonyms	2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol hydrate; UK-49858; Diflucan (brand name); Biozolene; Triflucan; Fluconazol; Fluconazolum; α-(2,4-Difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-1H-1,2,4-triazole-1-ethanol hydrate
EINECS	Contact for details

Quality Control

Our Fluconazole (Hydrate) is manufactured under strict quality systems. It is tested to meet relevant pharmacopeial standards such as USP, EP, and BP, ensuring identity, potency, purity, and consistency for pharmaceutical use. A comprehensive Certificate of Analysis (COA) detailing all test results, including assay, related substances, and residual solvents, is provided with each batch to guarantee regulatory compliance and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to prevent moisture absorption, which may affect stability and handling properties.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	4.5% - 6.5%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.