Int J Pharm Bio Sci Volume 2 Issue 4, 2011 (October - December), Pages:461-471
Process Validation Of Fluconazole
Bodavula Samba Siva Rao K.Raveendra Babu And D.Praveen Kumar
DOI:
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.