ISO INTERNATIONAL STANDARD 21316 First edition 2019-02 Traditional Chinese medicine Isatis indigotica root Médecine traditionnelle chinoise - Racine d'Isatis indigotica Reference number IS0 21316:2019(E) so @IS02019 IS0 21316:2019(E) COPYRIGHTPROTECTEDDOCUMENT @ ISO 2019 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either IsO at the address below or Iso's member body in the country of the requester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +4122 749 0111 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2019 - All rights reserved IS0 21316:2019(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references ..1 3 Terms and definitions 4 Descriptions ..2 5 Requirements .3 5.1 Morphological features. .3 5.1.1 Appearance. .3 5.1.2 Colour 3 5.1.3 Dimension.. ..4 5.1.4 Stemresidue 4 5.1.5 Texture .4 5.1.6 Fracture. 4 5.1.7 Odour. .4 5.2 Moisture 4 5.3 Total ash .4 5.4 Acid-insoluble ash .4 5.5 Ethanol-soluble extractives. .4 5.6 Identification of maker compound 5.7 Content of marker compound. .4 5.8 Heavy metals ..4 5.9 Pesticide residues. 4 6 Sampling. .5 7 Test methods. .5 7.1 .5 Macroscopic identification 7.2 Determination of moisture content .5 7.3 Determinationoftotalashcontent ..5 7.4 Determinationofacid-insolubleashcontent .5 7.5 Determination ofethanol-extractives content .6 7.6 Thin-layer chromatogram (TLC) identification .6 7.7 Determination of marker compound content. .6 7.8 Determination of heavy metals contents. ..6 7.9 Determination of pesticide residues contents. . 6 8 Test report. .6 9 Packaging, storage and transportation ..6 10 Marking and labelling ..6 Annex A (informative) Determination of ethanol-soluble extractives. ..8 Annex B (informative) Thin-layer chromatogram (TLC) identification .9 Annex C (informative) Determination of (R,S)-goitrin content ..11 Annex D (informative) National and regional limits of moisture, total ash, acid-insoluble ash, (R,S)-goitrin and ethanol-soluble extractive contents in Isatis indigotica root ..13 Bibliography .14 @ IS0 2019 - All rights reserved iii