Patent ID: 9097692
Filing Date: 2015-08-04
Classification: G01N,Y10T

Abstract:
1. A method for quantitatively determining impurities in glycerin serving for preparing pharmaceuticals, wherein the glycerin contains impurities; the impurities are glyceraldehyde, dihydroxyacetone, hydroxyacetone and formaldehyde; and the method comprises the following steps: (a) derivatizing the impurities by reacting the glycerine in a buffered aqueous sample solution comprising a derivatization reagent and a polar organic solvent, wherein the buffered aqueous sample solution is at a pH of about between 2 and 7; and the derivatization reagent is O -(2,3,4,5,6-pentafluorobenzyl)-hydroxylamine hydrochloride (PFBHA); (b) separating the derivatized impurities of step (a) via high pressure liquid chromatography (HPLC) using a mobile phase A which is water buffered with phosphoric acid and a mobile phase B which is acetonitrile; and (c) determining the quantity of the impurities by detecting the separated derivatized impurities of step (b) using ultraviolet (UV) detection at a wavelength of 190 to 250 nm and comparing the results of the UV detection to a standard derivatized calibrating solution containing the impurities.