Traditional Chinese medicine — Ephedra sinica, Ephedra intermedia and Ephedra equisetina herbaceous stem

This document specifies the quality and safety requirements of Ephedra herbaceous stem, which is the dried herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et C. A. Mey. or Ephedra equisetina Bge. (Fam. Ephedraceae). This document applies to Ephedra herbaceous stem 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.

Médecine traditionnelle chinoise — Tige herbacée d'Ephedra sinica, d'Ephedra intermedia et d'Ephedra equisetina

General Information

Status
Published
Publication Date
23-Nov-2023
Current Stage
6060 - International Standard published
Start Date
24-Nov-2023
Due Date
24-Nov-2024
Completion Date
24-Nov-2023
Ref Project

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ISO 9306:2023 - Traditional Chinese medicine — Ephedra sinica, Ephedra intermedia and Ephedra equisetina herbaceous stem Released:24. 11. 2023
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ISO/FDIS 9306 - Traditional Chinese medicine — Ephedra sinica, Ephedra intermedia and Ephedra equisetina herbaceous stem Released:8/23/2023
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Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 9306
First edition
2023-11
Traditional Chinese medicine —
Ephedra sinica, Ephedra intermedia
and Ephedra equisetina herbaceous
stem
Reference number
ISO 9306:2023(E)
© ISO 2023

---------------------- Page: 1 ----------------------
ISO 9306:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 9306:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . .1
5 Requirements . 2
5.1 General characteristics . 2
5.2 Morphological features . 2
5.3 Microscopic identification . 3
5.4 Thin-layer chromatography (TLC) identification . 4
5.5 Foreign matter . 4
5.6 Moisture . 4
5.7 Total ash . 4
5.8 Heavy metals . 4
5.9 Pesticide residues . 4
5.10 Marker compounds . 4
6 Sampling . 4
7 Test methods .
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 9306
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Ephedra sinica, Ephedra intermedia
Voting begins on:
2023-09-06 and Ephedra equisetina herbaceous
stem
Voting terminates on:
2023-11-01
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
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 9306:2023(E)
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. © ISO 2023

---------------------- Page: 1 ----------------------
ISO/FDIS 9306:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 9306
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Ephedra sinica, Ephedra intermedia
Voting begins on:
and Ephedra equisetina herbaceous
stem
Voting terminates on:
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 9306:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 2 ----------------------
ISO/FDIS 9306:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . .1
5 Requirements . 2
5.1 General characteristics . 2
5.2 Morphological features . 2
5.3 Microscopic identification . 3
5.4 Thin-layer chromatography (TLC) identification . 4
5.5 Foreign matter . 4
5.6 Moisture .
...

FINAL DRAFT INTERNATIONAL STANDARD
ISO/FDIS 9306
ISO/TC 249
Date: 2023-06-16
Secretariat: SAC
Date: 2023-08-22
Traditional Chinese medicine — Ephedra sinica, Ephedra
intermedia and Ephedra equisetina herbaceous stem
FDIS stage
© ISO 2023 – All rights reserved

---------------------- Page: 1 ----------------------
ISO/FDIS 9306:2023(E)
© ISO 2023
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'sISO’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
Fax: +41 22 749 09 47
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/FDIS 9306:2023(E)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . 1
5 Requirements . 3
5.1 General characteristics . 3
5.2 Morphological features . 3
5.3 Microscopic identification . 3
5.4 Thin-layer chromatography (TLC) identification . 5
5.5 Foreign matter . 5
5.6 Moisture . 5
5.7 Total ash. 5
5.8 Heavy metals . 5
5.9 Pesticide residues . 5
5.10 Marker compounds . 5
6 Sampling . 5
7 Test methods . 5
7.1 Macroscopic identification . 5
7.2 Microscopic identification .
...

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