BS EN ISO 21676:2021

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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

Published By	Publication Date	Number of Pages
BSI	2021	44

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Categories: 13.060.50 - Examination of water for chemical substances, BSI

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Description

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.

Table 1

Substances for which a determination was tested in accordance with this method

^a IUPAC: International Union of Pure and Applied Chemistry.

^b CAS-RN: Chemical Abstracts System Registration Number.

PDF Catalog

PDF Pages	PDF Title
2	undefined
6	Foreword
7	Introduction
9	1 Scope
12	2 Normative references 3 Terms and definitions 4 Principle 5 Interferences 5.1 During sample preparation 5.2 During high performance liquid chromatography and mass spectrometry
13	6 Reagents 6.1 General 6.2 Preparation of solutions
15	7 Apparatus
16	8 Sampling 9 Procedure 9.1 General 9.2 Sample preparation
17	9.3 High performance liquid chromatography (HPLC) 9.4 Detection 9.4.1 General
18	9.4.2 Tandem mass spectrometry (MS/MS) 9.4.3 High-resolution mass spectrometry (HRMS) 9.5 Blank value measurements 10 Calibration 10.1 General
20	10.2 Calibration with external standard 10.3 Calibration with internal standard
21	11 Calculation of recovery 11.1 General 11.2 Calculation of analyte recovery using samples
22	11.3 Recovery of internal standards 12 Evaluation 12.1 Verification of individual substances
23	12.2 Calculation of the individual results using calibration with an external standard 12.3 Calculation of the individual results using calibration with an internal standard
24	13 Expression of results 14 Test report
25	Annex A (informative) Performance data
30	Annex B (informative) Examples of recovery
32	Annex C (informative) Examples of HPLC columns and chromatograms
38	Annex D (informative) Examples of detection
41	Annex E (informative) Examples of extension of the method
42	Bibliography

Additional information

Carbamazepine 5H-Dibenzo[b,f]azepine-5-carbamide	C15H12N2O
Corrects	BS ISO 21676:2018
Iopamidol (S)-N,N′-Bis[2-hydroxy-1-(hydroxymethyl)ethyl]-5-[(2-hydroxypropanoyl)amino]-2,4,6-triiodobenzene-1,3-dicarbamide	C17H22I3N3O3
Publisher	BSI
Diazepam (RS)-7-Chlor-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepine-2-on	C16H13ClN2O
Metoprolol (RS)-1-(Isopropylamino)-3-[4-(2-methoxyethyl) phenoxy]propan-2-ol	C15H25NO3
Clarithromycin (2R,3R,4S,5R,8R,9S,10S,11R,12R,14R)-11-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-5-ethyl-3,4-dihydroxy-9-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyl-oxan-2-yl]oxy-12-methoxy-2,4,8,10,12,14-hexa-methyl-6-oxacyclotetradecane-1,7-dione	C38H69NO13
Pages	44
4-Formylaminoantipyrine N-(2,3-Dihydro-1,5-dimethyl-3-oxo-2-phenyl-1H-pyrazol-4-yl)formamide	C12H13N3O2
Status	Definitive
Iomeprol (±)-N,N′-Bis-(2,3-dihydroxypropyl)-5-[(2-hydroxy-acetyl)methylamino]-2,4,6-triiodo isophthalamide	C17H22I3N3O8
Bezafibrate 2-{4-[2-(4-Chlorbenzamido)ethyl]phenoxyl}-2-methylpropanoic acid	C19H20ClNO4
Standard Number	BS EN ISO 21676:2021
Gemfibrozil 5-(2,5-Chlorophenoxy)-2,2-methylpropanoic acid	C15H22O3
Clofibric acid 2-(4-Chlorophenoxy)-2-methylpropanoic acid	C10H11ClO3
10,11-Dihydro-10,11-dihydroxy carbamazepine (5S,6S)-5,6-Dihydroxy-5,6-dihydrobenzo[b][1]benzazepie-11-carboxamide	C15H14N2O3
Temazepam (RS)-7-Chloro-3-hydroxy-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one	C16H13ClN2O2
Iopromide (±)-N,N′-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-(2-methoxyacetamido)-N-methylisophthalamide	C18H24I3N3O8
Propyphenazone 1,5-Dimethyl-4-(1-methylethyl)-2-phenyl-1,2-dihydro-3H-pyrazol-3-one	C14H18N2O
Diatrizoic acid (amidotricoic acid) 3,5-Bis(acetamido)-2,4,6-triiodobenzoic acid	C11H9I3N2O4
Title	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
Erythromycin 6-(4-Dimethylamino-3-hydroxy-6-methyl-oxan-2-yl)oxy-14-ethyl-7,12,13-trihydroxy-4-(5-hydroxy-4-methoxy-4,6-dimethyl-oxan-2-yl)-oxy-3,5,7,9,11,13-hexamethyl-1-oxacyclotetradecane-2,10-dione	C37H67NO13
Primidone 5-Ethyl-5-phenylhexahydropyrimidin-4,6-dione	C12H14N2O2
Sulfamethoxazole 4-Amino-N-(5-methyl-1,2-oxazol-3-yl)benzene-sulfonamide	C10H11N3O3S
Ibuprofen (RS)-2-[4-(2-Methylpropyl)phenyl]propanoic acid	C13H18O2
Atenolol (RS)-2-[4-[2-Hydroxy-3-(1-methylethylamino) propoxy]phenyl]ethanamide	C14H22N2O3
Diclofenac 2-[2-[(2,6-Dichlorphenyl)amino]phenyl]acetic acid	C14H11Cl2NO2
4-Acetylaminoantipyrine N-(2,3-Dimethyl-5-oxo-1-phenyl-3-pyrazolin-4-yl)acetamide	C13H15N3O2
Naproxen (S)-2-(6-Methoxy-2-naphthyl)propanoic acid	C14H14O3
Committee	EH/3/2
Roxithromycin (3R,4S,5S,6R,7R,9R,11S,12R,13S,14R)-6-{[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy}-14-ethyl-7,12,13-trihydroxy-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy}-3,5,7,9,11,13-hexamethyl-10-(2,4,7-trioxa-1-azaoctan-1-ylidene)-1-oxacyclotetradecane-2-one	C41H76N2O15
Dehydrato-Erythromycin (anhydro-erythromycin) (2R,3R,4S,5S,8R,9S,10S,11R,12R)-11-{[4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy}-5-ethyl-3-hydroxy-9-[(5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl)oxy]-2,4,8,10,12,14-hexamethyl-6,15,16-trioxatricyclo[10.2.1.1{1,4}]hexadecane-7-one	C37H65NO12
Bisoprolol (RS)-1-[4-(2-Isopropoxyethoxymethyl)phenoxy]-3-isopropylamino-2-propanol	C18H31NO4
Publication Date	2021-08-11
ISBN	978 0 539 16731 3
Phenazone 1,5-Dimethyl-2-phenyl-2,3-dihydro-1H-pyrazol-3-on	C11H12N2O
N4-Acetyl sulfamethoxazole N-{4-[(5-Methyl-1,2-oxazol-3-yl)sulfamoyl]phenyl}-acetamide	C12H13N3O4S
Sotalol (RS)-4′-(1-Hydroxy-2-isopropylaminoethyl) methanesulfonanilide	C12H20N2O3S
Identical National Standard Of	ISO 21676:2018, EN ISO 21676:2021
Descriptors	Test specimens, Potable water, Quality, Chemical analysis and testing, Containers, Preservation, Water testing, Water, Biological analysis and testing, Laboratory testing, Water treatment, Samples
Oxazepam (RS)-7-Chloro-3-hydroxy-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-on	C15H11ClN2O2
ICS Codes	13.060.50 - Examination of water for chemical substances
Trimethoprim 2,4-Diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine	C14H18N4O3

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