Регуляторные исследования и экспертиза лекарственных средств (Feb 2018)
New opportunities for the determination of active substances in organic compounds
Abstract
The general monograph developed for the Russian State Pharmacopoeia describes the opportunity for using special equipment called «elemental analyzer» to solve the problem of determining active ingredients in pharmaceuticals by determining the elements C, H, N, S. The method is based on the high-temperature oxidative decomposition in a stream of helium, or in its mixture with oxygen in the presence of an catalyst of oxidation to inorganic substances corresponding the mentioned elements, reduction of nitrogen oxides to molecular nitrogen in the presence of the respective reduction catalyst and determining the corresponding decomposition products by gas chromatography. This method is fast and does not require the analysis of a sample of an active substance.