RESIDUAL SOLVENT ANALYSIS BY HEADSPACE GAS-CHROMATOGRAPHY

An automated headspace GC method was developed and validated for the analyses of eight common process solvents and the five solvents whose quantification is required by the US Pharmacopeia. The sample is dissolved in dimethylformamide solvent and the equilibrium headspace gas formed at 60 degrees C is analyzed using a megabore capillary column. Quantification is performed by the standard addition technique to eliminate any possibility of matrix effects. This method is sensitive, precise, accurate and linear in the range of interest.