Buletinul Institutului Politehnic din Iași Secția Chimie și Inginerie Chimică ISSN: 2537-2947
ISSN-L: 0254-7104
2024, Volume 70(74), Issue 2 (June), pp. 77 - 91
Qualitative And Quantitative Analysis of Impurities in Chlorocholine
Chloride: A Review
LILIANA LAZĂR, “Gheorghe Asachi” Technical University
of Iași, “Cristofor Simionescu” Faculty of Chemical Engineering and
Environmental Protection, Iași, Romania,
liliana.lazar@academic.tuiasi.ro GEORGIANA MARDARE
(BĂLUȘESCU), “Gheorghe Asachi” Technical University of Iași,
“Cristofor Simionescu” Faculty of Chemical Engineering and Environmental
Protection, Iași, Romania DUMITRU COMAN, CHIMCOMPLEX
S.A., Borzești, Romania
Abstract 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. Keywords:
characterization, detection, separation, 1,2-dichloroethane, trimethylamine