Qualitative And Quantitative Analysis of Impurities in Chlorocholine Chloride: A Review

This study provides an overview of impurities in an active substance / active ingredient and selective analytical methods of impurities for their identification in chlorocholine chloride with applications and literature references. Moreover, its reviews the importance to understanding what determinates an impurity and identification of potential sources of this impurity is discussed. The analytes include 1,2-dichloroethane and trimethylamine which are relevant impurities acceptable by Food and Agriculture Organization of the United Nations and World Health Organization. After a concise resume introduction regarding the properties of chlorocholine chloride, attention is focused primarily to separation, identification and detection for qualitative and quantitative analysis of these two analytes. The determination method used after identification of impurities are also discussed. In comparation with spectroscopic (UV-Vis, FTIR, NMR), spectrometric (MS), chromatographic (GC, IC) characterization methods, applications in impurities analysis have demonstrated that coupled or tandem techniques (CG-MS, GLC-MS, HPLC-UV-VIS) gain popularity regarding selectivity, high sensitivity, reliability, good accuracy, robustness and precision for monitoring the impurities from chlorocholine chloride production. According to European Food Safety Authority, chromatographic techniques are recommended for identification purpose.