Description

Voriconazole is a broad-spectrum triazole antifungal agent, representing a second-generation synthetic derivative of fluconazole. Its primary value lies in its enhanced potency and expanded spectrum of activity against serious, invasive fungal infections, including those resistant to other azole antifungals. This makes it a critical active pharmaceutical ingredient (API) for the formulation of injectable and oral medications, primarily targeting the pharmaceutical manufacturing sector for the production of life-saving antifungal therapies.

Application

• As the active pharmaceutical ingredient (API) in the manufacture of generic and branded antifungal medications.
• Formulation of injectable solutions for the treatment of invasive aspergillosis and other systemic fungal infections in hospital settings.
• Production of oral tablets and suspensions for step-down therapy and treatment of esophageal candidiasis.
• Used in clinical research and development of new antifungal combination therapies.
• Essential for compounding pharmacies requiring high-purity APIs for specialized patient treatments.
• Serves as a reference standard in analytical laboratories for quality control and method development.

Basic Information

Product Name	Voriconazole
CAS No.	137234-62-9
Molecular Formula	C16H14N5FO5
Molecular Weight	349.31 g/mol
Synonyms	(2R,3S)-2-(2,4-Difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol; UK-109,496; Vfend (Brand Name); (αR,βS)-α-(2,4-Difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol; 4-Pyrimidineethanol, α-(2,4-difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-, (αR,βS)-
EINECS	Contact for details

Quality Control

Our Voriconazole is manufactured under strict quality management systems. It is tested to meet stringent specifications relevant for pharmaceutical API production, with a focus on purity, impurity profiles, and microbiological quality. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results for identity, assay, related substances, residual solvents, and other critical parameters. We support compliance with major pharmacopeial standards, including USP and EP.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 0.5%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%
Microbial Enumeration	Complies with EP/USP

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