The purpose of the study was a development of a new method for the determination of class IIC residual solvents in following organic solvents: dimethylsulphoxide (DMSO), N,N-dimethylformamide (DMF), N,N-dimethylacetamide (DMA) by gas chromatography (GC). In this analytical method we used helium as the carrier gas and high polarity column together with FID as a detector. This GC method is intended to be used for identifying and quantifying residual solvents in DMSO, DMF, DMA. These solvents are used as dissolvents for analysis of residual solvents in drug substances, excipients or drug products. They must meet the requirements of the maximum allowable amounts of residual solvents determined by special guidelines included in ICH (Q3C) and pharmacopeias (USP 467, European). The organic solvents are constantly present in the pharmaceutical production and they are difficult to be completely removed in the manufacturing processes of pharmaceuticals. A low assay of these solvents, which may remain in the final product. They are called residual solvents or they are known as organic volatile impurities (OVI). The class II residual solvents are described as nongenotoxic animal carcinogens. The content of these solvents should be evaluated, justified and limited in the final drug products because of their inherent toxicity. In our research popular diluents like: DMSO, DMF DMAc were used as test samples. It was difficult to determine following class IIC impurities (in accordance with USP): N,N-dimethylacetamide, N,N-dimethyl-formamide, 2-ethoxyethanol, 2-methoxyethanol, ethyleneglycol, formamide, N-methyl-pyrrolidone, sulfolane in these liquid samples. The peaks from these dissolvents were co-eluated with the peaks from analities in the chromatograms obtained with test samples. The established method can be used in routine control of class II C residual solvents.

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1. Determination of formic acid in organic solvents by GC-TCD