This method describes the determination of formic acid in organic solvents, which are frequently used in the gas chromatography analysis of pharmaceutical substances. Residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. The residual solvents are not completely removed by practical manufacturing techniques.
This method allows to directly determine the formic acid in the organic solvents, without a necessity of the derivatization reaction. Formic acid was analyzed by high-resolution capillary gas chromatography with thermal conductivity detector (GC-TCD) and it was measured in organic solvents like dimethylsulphoxide (DMSO), N,N-dimethylformamide (DMF), N,N-dimethylacetamide (DMA). The lowest measured signal for formic acid was 10 ppm. Acetone and equivalent solvents were mixed to prepare standards and test solutions. The results for the determination of formic acid by GC-TCD confirmed, that the method can be used to routine control of the residual formic acid.

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1. Method development for the determination of class II C residual solvents by GC