EN ISO 21676:2021

Water quality - Determination of the dissolved fraction of selected active pharmaceutical ingredients, transformation products and other organic substances in water and treated waste water - Method using high performance liquid chromatography and mass spectrometric detection (HPLC-MS/MS or -HRMS) after direct injection (ISO 21676:2018)

This document specifies a method for the determination of the dissolved fraction of selected active pharmaceutical ingredients and transformation products, as well as other organic substances (see Table 1) in drinking water, ground water, surface water and treated waste water.
The lower application range of this method can vary depending on the sensitivity of the equipment used and the matrix of the sample. For most compounds to which this document applies, the range is ≥ 0,025 µg/l for drinking water, ground water and surface water, and ≥ 0,050 µg/l for treated waste water.
The method can be used to determine further organic substances or in other types of water (e.g. process water) provided that accuracy has been tested and verified for each case, and that storage conditions of both samples and reference solutions have been validated. Table 1 shows the substances for which a determination was tested in accordance with the method. Table E.1 provides examples of the determination of other organic substances.

Wasserbeschaffenheit - Bestimmung ausgewählter Arzneimittelwirkstoffe, Transformationsprodukte und weiterer organischer Stoffe gelöst in Wasser und behandeltem Abwasser - Verfahren mittels Hochleistungs-Flüssigkeitschromatographie und massenspektrometrischer Detektion (HPLC-MS/MS oder -HRMS) nach Direktinjektion (ISO 21676:2018)

Dieses Dokument legt ein Verfahren zur Bestimmung des gelösten Anteils ausgewählter Arzneimittelwirkstoffe und Transformationsprodukte sowie weiterer organischer Substanzen (siehe Tabelle 1) in Trink-, Grund-, Oberflächen- und behandeltem Abwasser fest.
Der untere Anwendungsbereich des Verfahrens kann abhängig von der Empfindlichkeit der verwendeten Geräte und von der Matrix der Probe variieren. Für die meisten Verbindungen, für die dieses Dokument Anwendung findet, ist der Bereich ≥ 0,025 µg/l in Trink-, Grund- und Oberflächenwasser und ≥ 0,050 µg/l in behandeltem Abwasser.
Das Verfahren kann zur Bestimmung weiterer organischer Stoffe oder in anderen Wasserarten angewandt werden (z. B.: Brauchwasser), wenn die Richtigkeit im Einzelfall geprüft und nachgewiesen wurde und die Lagerbedingungen von Proben und Referenzlösungen validiert wurden. Tabelle 1 zeigt die Substanzen, für die eine Bestimmung nach dem Verfahren getestet wurde. Tabelle E.1 enthält Beispiele für die Bestimmung anderer organischer Substanzen.
[Tabelle 1]

Qualité de l'eau - Détermination de la fraction dissoute des ingrédients pharmaceutiques actifs sélectionnés, des produits de la transformation et d'autres substances organiques dans l'eau et dans l'eau résiduaire - Méthode par chromatographie en phase liquide à haute performance et détection par spectrométrie de masse (CLHP-MS/MS ou -HRSM) après l'injection directe (ISO 21676:2018)

Le présent document spécifie une méthode de détermination de la fraction dissoute des principes actifs pharmaceutiques sélectionnés et de leurs produits de transformation, ainsi que d'autres substances organiques (voir Tableau 1), dans l'eau potable, les eaux souterraines, les eaux de surface et les eaux usées traitées.
La gamme d'application basse de la présente méthode peut varier selon la sensibilité de l'équipement utilisé et la matrice de l'échantillon. Pour la plupart des composés concernés par le présent document, la gamme est ≥ 0,025 µg/l pour l'eau potable, les eaux souterraines et les eaux de surface, et ≥ 0,050 µg/l pour les eaux usées traitées.
La présente méthode peut être utilisée pour déterminer d'autres substances organiques ou pour d'autres types d'eaux (par exemple, l'eau de process), à condition que l’exactitude ait été testée et vérifiée dans chaque cas, et que les conditions de conservation des échantillons et des solutions de référence aient été validées. Le Tableau 1 indique les substances pour lesquelles la présente méthode a été appliquée. Le Tableau E.1 fournit d’autres exemples de substances organiques pour lesquelles la présente méthode peut être utilisée.

Kakovost vode - Določevanje raztopljenih frakcij izbranih aktivnih farmacevtskih učinkovin, produktov razgradnje in drugih organskih spojin v vodi in obdelani odpadni vodi - Metoda tekočinske kromatografije visoke ločljivosti in masne spektrometrije (HPLC-MS/MS ali -HRMS) po neposrednem injiciranju (ISO 21676:2018)

General Information

• Status: Published
• Publication Date: 03-Aug-2021
• Withdrawal Date: 27-Feb-2022
• ICS: 13.060.50 - Examination of water for chemical substances
• Technical Committee: CEN/TC 230 - Water analysis
• Drafting Committee: CEN/TC 230/WG 1 - Physical and biochemical methods
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 04-Aug-2021
• Due Date: 02-Feb-2023
• Completion Date: 04-Aug-2021
• Directive: 2000/60/EC - Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (substitutes Directive Reference 01/991 - Common Position on WFD)
• Ref Project: SIST EN ISO 21676:2021 - Water quality - Determination of the dissolved fraction of selected active pharmaceutical ingredients, transformation products and other organic substances in water and treated waste water - Method using high performance liquid chromatography and mass spectrometric detection (HPLC-MS/MS or -HRMS) after direct injection (ISO 21676:2018)

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2021
Kakovost vode - Določevanje raztopljenih frakcij izbranih aktivnih farmacevtskih
učinkovin, produktov razgradnje in drugih organskih spojin v vodi in obdelani
odpadni vodi - Metoda tekočinske kromatografije visoke ločljivosti in masne
spektrometrije (HPLC-MS/MS ali -HRMS) po neposrednem injiciranju (ISO
21676:2018)
Water quality - Determination of the dissolved fraction of selected active pharmaceutical
ingredients, transformation products and other organic substances in water and treated
waste water - Method using high performance liquid chromatography and mass
spectrometric detection (HPLC-MS/MS or -HRMS) after direct injection (ISO
21676:2018)
Wasserbeschaffenheit - Bestimmung ausgewählter Arzneimittelwirkstoffe,
Transformationsprodukte und weiterer organischer Stoffe gelöst in Wasser und
gereinigtem Abwasser - Verfahren mittels Hochleistungs-Flüssigkeitschromatographie
und massenspektrometrischer Detektion (HPLC-MS/MS oder -HRMS) nach
Direktinjektion (ISO 21676:2018)
Qualité de l'eau - Détermination de la fraction dissoute des ingrédients pharmaceutiques
actifs sélectionnés, des produits de la transformation et d'autres substances organiques
dans l'eau et dans l'eau résiduaire - Méthode par chromatographie en phase liquide à
haute performance et détection par spectrométrie de masse (CLHP-MS/MS ou -HRSM)
après l'injection directe (ISO 21676:2018)
Ta slovenski standard je istoveten z: EN ISO 21676:2021
ICS:
13.060.50 Preiskava vode na kemične Examination of water for
snovi chemical substances
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 21676
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2021
EUROPÄISCHE NORM
ICS 13.060.50
English Version
Water quality - Determination of the dissolved fraction of
selected active pharmaceutical ingredients, transformation
products and other organic substances in water and
treated waste water - Method using high performance
liquid chromatography and mass spectrometric detection
(HPLC-MS/MS or -HRMS) after direct injection (ISO
21676:2018)
Qualité de l'eau - Détermination de la fraction dissoute Wasserbeschaffenheit - Bestimmung ausgewählter
des ingrédients pharmaceutiques actifs sélectionnés, Arzneimittelwirkstoffe, Transformationsprodukte und
des produits de la transformation et d'autres weiterer organischer Stoffe gelöst in Wasser und
substances organiques dans l'eau et dans l'eau gereinigtem Abwasser - Verfahren mittels
résiduaire - Méthode par chromatographie en phase Hochleistungs-Flüssigkeitschromatographie und
liquide à haute performance et détection par massenspektrometrischer Detektion (HPLC-MS/MS
spectrométrie de masse (CLHP-MS/MS ou -HRSM) oder -HRMS) nach Direktinjektion (ISO 21676:2018)
après l'injection directe (ISO 21676:2018)
This European Standard was approved by CEN on 18 July 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21676:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 21676:2018 has been prepared by Technical Committee ISO/TC 147 "Water quality” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 21676:2021
by Technical Committee CEN/TC 230 “Water analysis” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2022, and conflicting national standards
shall be withdrawn at the latest by February 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 21676:2018 has been approved by CEN as EN ISO 21676:2021 without any modification.

INTERNATIONAL ISO
STANDARD 21676
First edition
2018-10
Water quality — Determination of
the dissolved fraction of selected
active pharmaceutical ingredients,
transformation products and
other organic substances in
water and treated waste water —
Method using high performance
liquid chromatography and mass
spectrometric detection (HPLC-MS/MS
or -HRMS) after direct injection
Qualité de l'eau — Détermination de la fraction dissoute des
ingrédients pharmaceutiques actifs sélectionnés, des produits de la
transformation et d'autres substances organiques dans l'eau et dans
l'eau résiduaire — Méthode par chromatographie en phase liquide à
haute performance et détection par spectrométrie de masse (CLHP-
MS/MS ou -HRSM) après l'injection directe
Reference number
ISO 21676:2018(E)
©
ISO 2018
ISO 21676:2018(E)
© ISO 2018
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
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Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 21676:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 4
3 Terms and definitions . 4
4 Principle . 4
5 Interferences . 4
5.1 During sample preparation . 4
5.2 During high performance liquid chromatography and mass spectrometry . 4
6 Reagents . 5
6.1 General . 5
6.2 Preparation of solutions . 5
7 Apparatus . 7
8 Sampling . 8
9 Procedure. 8
9.1 General . 8
9.2 Sample preparation . 8
9.3 High performance liquid chromatography (HPLC) . 9
9.4 Detection . 9
9.4.1 General. 9
9.4.2 Tandem mass spectrometry (MS/MS) .10
9.4.3 High-resolution mass spectrometry (HRMS) .10
9.5 Blank value measurements .10
10 Calibration .10
10.1 General .10
10.2 Calibration with external standard .12
10.3 Calibration with internal standard .12
11 Calculation of recovery .13
11.1 General .13
11.2 Calculation of analyte recovery using samples .13
11.3 Recovery of internal standards .14
12 Evaluation .14
12.1 Verification of individual substances .
...