Benzene is a highly toxic solvent that should be limited to no more than 2 ppm in drug substances, as regulated by the International Council for Harmonization guideline Q3C. We herein report quantification of benzene in the Pantoprazole sodium drug substance using head space gas chromatography (HS-GC). Range of the method was from 0.67 to 3.02 ppm according to the results of linearity, accuracy and precision, and limits of detection and quantitation of the method were 0.22 and 0.67 ppm, respectively.

Key Words: Benzene, Pantoprazole Sodium drug substance, ICH guidelines, Validation.