ISO 5076:2024

Traditional Chinese medicine — Angelica dahurica root

This document specifies the quality and safety requirements of Angelica dahurica root [the dried root of Angelica dahurica (Fish.ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav.]. This document applies to Angelica dahurica root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.

Titre manque

General Information

• Status: Published
• Publication Date: 21-May-2024
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 6060 - International Standard published
• Start Date: 22-May-2024
• Due Date: 01-Apr-2025
• Completion Date: 22-May-2024

Standards Content (Sample)

International
Standard
ISO 5076
First edition
Traditional Chinese medicine —
2024-05
Angelica dahurica root
Reference number
ISO 5076:2024(en) © ISO 2024

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ISO 5076:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2024
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland

© ISO 2024 – All rights reserved
ii

---------------------- Page: 2 ----------------------
ISO 5076:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 1
5 Quality and safety requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological features .2
5.3 Thin-layer chromatogram (TLC) identification .3
5.4 Moisture .3
5.5 Total ash .3
5.6 Acid-insoluble ash .3
5.7 Dilute ethanol-soluble extractives .3
5.8 Heavy metals .3
5.9 Pesticide residues .3
5.10 Marker compound .3
6 Sampling . 3
7 Test methods .
...

FINAL DRAFT
International
Standard
ISO/FDIS 5076
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Angelica dahurica root
Voting begins on:
2024-03-07
Voting terminates on:
2024-05-02
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 5076:2024(en) © ISO 2024

---------------------- Page: 1 ----------------------
FINAL DRAFT
ISO/FDIS 5076:2024(en)
International
Standard
ISO/FDIS 5076
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Angelica dahurica root
Voting begins on:
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
COPYRIGHT PROTECTED DOCUMENT
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 5076:2024(en) © ISO 2024

© ISO 2024 – All rights reserved
ii

---------------------- Page: 2 ----------------------
ISO/FDIS 5076:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 1
5 Quality and safety requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological features .2
5.3 Thin-layer chromatogram (TLC) identification .3
5.4 Moisture .3
5.5 Total ash .3
5.6 Acid-insoluble ash .
...

2024-01-29
ISO/FDIS 5076:2024(E)
ISO/TC249/WG 1TC 249
Secretariat: SAC
Date: 2024-02-21
Traditional Chinese medicine — Angelica dahurica root
FDIS stage

---------------------- Page: 1 ----------------------
ISO/FDIS 5076:2024(Een)
© ISO 20232024
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: + 41 22 749 01 11
EmailE-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
© ISO 2023 2024 – All rights reserved

ii

---------------------- Page: 2 ----------------------
ISO/FDIS 5076:2024(Een)
Contents
Foreword . Error! Bookmark not defined.
Introduction . Error! Bookmark not defined.
1 Scope . Error! Bookmark not defined.
2 Normative references . Error! Bookmark not defined.
3 Terms and definitions . Error! Bookmark not defined.
4 Descriptions . Error! Bookmark not defined.
5 Quality and safety requirements and recommendations . Error! Bookmark not defined.
5.1 General characteristics . Error! Bookmark not defined.
5.2 Morphological features . Error! Bookmark not defined.
5.3 Thin-layer chromatogram (TLC) identification . Error! Bookmark not defined.
5.4 Moisture . Error! Bookmark not defined.
5.5 Total ash . Error! Bookmark not defined.
5.6 Acid-insoluble ash . Error! Bookmark not defined.
5.7 Dilute ethanol-soluble extractives . Error! Bookmark not defined.
5.8 Heavy metals . Error! Bookmark not defined.
5.9 Pesticide residues . Error! Bookmark not defined.
5.10 Marker compound . Error! Bookmark not defined.
6 Sampling . Error! Bookmark not defined.
7 Test methods . Error! Bookmark not defined.
7.1 Macroscopic identification . Error! Bookmark not defined.
7.2 Thin-layer chromatogram (TLC) identification . Error! Bookmark not defined.
7.3 Determination of moisture content . Error! Bookmark not defined.
7.4 Determination of total ash content . Error! Bookmark not defined.
7.5 Determination of acid-insoluble ash content . Error! Bookmark not defined.
7.6 Determination of dilute ethanol-soluble extractives content . Error! Bookmark not defined.
7.7 Determination of heavy metal contents . Error! Bookmark not defined.
7.8 Determination of pesticide residues contents . Error! Bookmark not defined.
7.9 Determination of marker compound . Error! Bookmark not defined.
8 Test report . Error! Bookmark not defined.
9 Packaging, storage and transportation . Error! Bookmark not defined.
10 Marking and labelling . Error! B
...