2011, №4

сс. 51-58

A new approach to the comparison of original pharmaceuticals and generics, based on comparison of multidimensional impurity profiles using supercritical fluid extraction, liquid extraction and GC-MS

2011, №4

сс. 51-58

Цитировать

A.I. Revelsky, I.N. Glazkov, Yu.S. Yashin, D.A. Chepelyansky, A.S. Samokhin, D.A. Burmykin, I.A. Revelsky

Key words: impurities in pharmaceuticals, generics, GC-MS, derivatization, supercritical fluid extraction, liquid extraction, atmospheric pressure photochemical ionization mass-spectrometry

The  possibility of comparison of original pharmaceuticals and their generics, based  on multidimensional profiles of impurities isolated from different samples by  supercritical fluid extraction and liquid extraction and registered by  gas-chromatography/mass-spectrometry with electron ionization (EI) and  atmospheric pressure photochemical ionization (APPCI) is investigated. The  utilization of the suggested approach allows one to increase of the number of  registered impurities and, thus, to identify the authenticity of  pharmaceutical samples and to compare the quality of original pharmaceuticals  and their generics.

doi:10.1134/S1990793111080094