Infant formula and adult nutritionals — Determination of trans and total (cis + trans) vitamin K1 content — Normal phase HPLC

This document specifies a method for the quantitative determination of trans and total (cis + trans) vitamin K1 in infant, pediatric and adult nutritionals using normal phase (NP) high-performance liquid chromatography (HPLC) with post-column reduction and fluorescence detection. The method demonstrated good linearity over a standard range of ~2 μg/l to 80 μg/l trans vitamin K1, and the limit of quantification (LOQ) was estimated to be 0,4 μg/l for standards and 0,09 μg/100 g ready to feed (RTF) for samples assuming 4 grams of sample are diluted to 10 ml.

Formules infantiles et produits nutritionnels pour adultes — Détermination de la teneur en vitamine K1 trans et totale (cis + trans) — Chromatographie liquide à haute performance (CLHP) en phase normale

General Information

Status
Published
Publication Date
06-Jan-2019
Current Stage
9020 - International Standard under periodical review
Start Date
15-Jan-2024
Completion Date
15-Jan-2024
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ISO 21446:2019 - Infant formula and adult nutritionals -- Determination of trans and total (cis + trans) vitamin K1 content -- Normal phase HPLC
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INTERNATIONAL ISO
STANDARD 21446
First edition
2019-01
Infant formula and adult
nutritionals — Determination of trans
and total (cis + trans) vitamin K
1
content — Normal phase HPLC
Formules infantiles et produits nutritionnels pour adultes —
Détermination de la teneur en vitamine K trans et totale (cis +
1
trans) — Chromatographie liquide à haute performance (CLHP) en
phase normale
Reference number
ISO 21446:2019(E)
©
ISO 2019

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ISO 21446:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© 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.
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Published in Switzerland
ii © ISO 2019 – All rights reserved

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ISO 21446:2019(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 1
5 Reagents and materials . 2
6 Standard and solution preparation . 2
6.1 Mixture with volume fraction of 10 % isopropanol in iso-octane . 2
6.2 Mobile phase . 2
6.3 Post-column electrolyte solution . 3
6.4 Vitamin K (phytonadione) stock standard solution . 3
1
6.4.1 Vitamin K (phytonadione) stock standard solution . 3
1
6.4.2 Stock standard concentration (for non USP standard) . 3
6.5 Vitamin K (phytonadione) intermediate I standard solution . 3
1
6.6 Vitamin K (phytonadione) intermediate II standard solution . 3
1
6.7 Vitamin K (phytonadione) working standard solutions . 3
1
7 Apparatus . 4
8 Procedure. 4
8.1 Sample preparation . 4
8.1.1 Liquid samples .
...

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