Process Validation Of Fluconazole

Abstract

Validation is the act of demonstrating and documenting that a procedure operates effectively. The U.S Food  and  Drug Administration (FDA) guidelines state that the process validation is the established documented evidence which provides a high degree of assurance that specific process.Fluconazole is a triazole antifungal drug used in the treatment and prevention of superficial and systemic fungal infections. In a bulk Powder form, it appears as a white crystalline powder, and it is very slightly soluble in water and soluble in alcohol. It is designated as 2,4-difluoro-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C₁₃H₁₂F₂N₆O and molecular weight 306.3.