ISO INTERNATIONAL STANDARD 23191 First edition 2020-07 Traditional Chinese medicine Determination of selected Aconitum alkaloids by high-performance liquid chromatography (HPLC) Medecine traditionnelle chinoise-Dosage d'alcaloides d'aconit (Aconitum)selectionnés par chromatographie liquide d haute performance (CLHP) Reference number IS0 23191:2020(E) ISO @IS02020 IS0 23191:2020(E) COPYRIGHTPROTECTEDDOCUMENT ISO2020 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may below or ISo's member body in the country of the requester. ISO copyright office CP 40i : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Email: copyright@iso.org Website: www.iso.org Published in Switzerland ii IS02020-Allrights reserved IS023191:2020(E) Contents Page Foreword iv Introduction V 1 Scope. .1 2 Normativereferences .1 3 Terms and definitions .1 4 Abbreviatedterms .1 5 Principle. .2 6 Reagents. .3 7 Apparatus. .3 8 Sampling. 4 9 Test procedures .4 9.1 General 4 9.2 HPLC-MS procedure 5 9.2.1 Reference solution. 5 9.2.2 Test solution 5 9.2.3 Chromatographicconditions. 5 9.2.4 HPLC-MS conditions 5 9.2.5 Determination. 55 9.3 HPLC-DAD procedure. 9.3.1 Reference solution. 5 9.3.2 Test solution 6 9.3.3 Chromatographicconditions. 6 9.3.4 Determination. 6 10 Test report .6 AnnexA(informative)TypicalHPLCconditions .7 AnnexB (informative)Typical chromatogram oftheselectedAconitum alkaloids .9 Annex C (informative) Typical Aconitum herb used in traditional Chinese medicine .12 Annex D (informative) Reference values of national and regional limits of Aconitum alkaloidsinAconitumcarmichaelilateralroot .13 Bibliography .14 @ IS0 2020 - All rights reserved iii