International ISO Standard ISO 13615 First edition Traditional Chinese medicine - 2024-07 Atractylodes macrocephala rhizome Médecine traditionnelle chinoise Rhizome d'Atractylodes macrocephala Reference number ISO 13615:2024(en) @ISO2024 IS0 13615:2024(en) COPYRIGHT PROTECTED DOCUMENT IS02024 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 memberbody inthe country ofthe requester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone:+41227490111 Email: copyright@iso.org Website: www.iso.org Published in Switzerland @ IS0 2024 - All rights reserved ii IS0 13615:2024(en) Contents Page Foreword .iv Introduction .V 1 Scope. 1 2 Normative references .1 3 Terms and definitions .1 4 .2 Descriptions. .3 5 Quality and safety requirements and recommendations ..3 5.1 General characteristics 5.2 Morphological features. .3 5.2.1 Atractylodes macrocephala rhizome .3 Decoction pieces. .3 5.2.2 5.3 Identification. .3 5.3.1 Thin-layer chromatography (TLC) identification .3 5.3.2 High performance liquid chromatography (HPLC) identification .3 5.4 .3 Moisture 5.5 Total ash. .4 .4 5.6 Sulfur dioxide residues. 5.7 Ethanol-soluble extractives .4 ..4 5.8 Essential oil 5.9 Heavy metals. 4 5.10 Pesticide residues ..4 Sampling. 6 Test methods .4 7 7.1 Macroscopic identification .4 ..4 7.2 Thin-layer chromatography (TLC) identification 7.3 High performance liquid chromatography (HPLC) identification 4 ..4 7.4 Determination of moisture content. 7.5 Determination of total ash content. 4 7.6 Determination of sulfur dioxide residues content. .4 7.7 Determination of ethanol-soluble extractives content. .5 7.8 Determination of essential oil content .5 .5 7.9 Determination of heavy metals content 7.10 Determination of pesticide residues content ..5 8 .5 Test report 9 Packaging, storage and transportation .5 .5 10 Marking and labelling 6 Annex A (informative) Thin-layer chromatography (TLC) identification Annex B (informative) High performance liquid chromatography (HPLC) identification ..8 Annex C (informative) Reference values of national and regional limits 11 Bibliography .12 @ IS0 2024 - All rights reserved iii