Analytische Qualitätssicherung Baden-Württemberg

Home , Iomeprol, Ioxaglic acid, Ioxitalamic acid

Proficiency Test 6/15 TW S6 – X-ray and contrast media

amidotrizoic acid, iodipamide, iohexol, iomeprol, iopamidol, iopromide, iothalamic acid, ioxaglic acid, ioxitalamic acid, gadonlinium, gadolinium anomaly

provided by AQS Baden-Württemberg at Institute for Sanitary Engineering, Water Quality and Solid Waste Management, University of Stuttgart Bandtäle 2, 70569 Stuttgart-Büsnau, Germany

and IWW Water Center Moritzstr. 26, 45476 Mülheim an der Ruhr, Germany

Stuttgart, in February 2016 Responsibilities:

Scientific director AQS: Dr.-Ing. Dipl.-Chem. Michael Koch PT manager: Dr.-Ing. Frank Baumeister AQS Baden-Württemberg at Institute of Sanitary Engineering, Water Quality and Solid Waste Management at University of Stuttgart Bandtäle 2 70569 Stuttgart-Büsnau Germany http://www.aqsbw.de Tel.: +49 (0)711 / 685-65446 Fax: +49 (0)711 / 685-63769 E-Mail: [email protected] PT 6/15 – TW S6

LIST OF CONTENTS GENERAL ...... 1 PT DESIGN ...... 1 SAMPLE PREPARATION ...... 1 SAMPLE DISTRIBUTION ...... 1 ANALYTICAL METHODS...... 2 SUBMISSION OF RESULTS ...... 2 EVALUATION PROCEDURE ...... 2 ASSESSMENT ...... 3 EVALUATION ...... 4 EXPLANATION OF APPENDIX A ...... 4 EXPLANATION OF APPENDIX B ...... 5 EXPLANATION OF APPENDIX C ...... 6 MEASUREMENT UNCERTAINTY ...... 7 TRACEABLE REFERENCE VALUES ...... 7 INTERNET ...... 8

Appendix A Amidotrizoic acid ...... A-1 Iodipamide ...... A-8 Iohexol ...... A-14 Iomeprol ...... A-21 Iopamidol ...... A-28 Iopromide...... A-35 Iothalamic acid ...... A-42 Ioxaglic acid ...... A-49 Ioxitalamic acid ...... A-55 Gadolinium ...... A-62 Gadolinium anomaly ...... A-68

Appendix B

Appendix C Amidotrizoic acid ...... C-1 Iodipamide ...... C-10 Iohexol ...... C-19 Iomeprol ...... C-28 Iopamidol ...... C-37 Iopromide...... C-46 Iothalamic acid ...... C-55 Ioxaglic acid ...... C-64 Ioxitalamic acid ...... C-73 Gadolinium ...... C-82 Gadolinium anomaly ...... C-91

PT 6/15 – TW S6 page 1

General This PT was provided by AQS Baden-Württemberg in cooperation with IWW Water Center in Mülheim an der Ruhr and with the network “NORMAN” (Network of reference laboratories for monitoring of emerging environmental pollutants). In this round following parameter were to be determined:

parameter CAS -number of the parameter amidotrizoic acid 117-96-4 iodipamide 606-17-7 iohexol 66108-95-0 iomeprol 78649-41-9 iopamidol 60166-93-0 Iopromide 73334-07-3 iothalamic acid 2276-90-6 Ioxaglic acid 59017-64-0 Ioxitalamic acid 28179-44-4 gadolinium 7440-54-2 Gd anomaly (evaluation informative) -

The PT was executed and evaluated according to the requirements of DIN 38402- A45 and ISO/TS 20612.

PT design Each participant received the following samples:

• 3 x 1 sample for the determination of amidotrizoic acid, iodipamide, iohexol, iomeprol, iopamidol, iopromide, iothalamic acid, ioxaglic acid and ioxitalamic acid in 1000-ml-ground bottles with ground-in stopper. • 3 x 1 sample for the determination of gadolinium and gadolinium anomaly in 50-ml-plastic tubes. Preservation with nitric acid.

3 different concentration levels/batches were produced. All participants received the same samples.

Sample preparation The samples for the determination of the X-ray and contrast media were based on a real ground water matrix. The ground water was used without treatment for the sample preparation.

The ground water was spiked with stock solutions and the concentrations covered drinking and ground water relevant ranges.

Sample distribution The samples were dispatched on 13 th October 2015 by express service.

PT 6/15 – TW S6 page 2

Analytical methods The participants were free to choose a suitable method, but following limits of quanti- fications were required: parameter limit of quantification [µg/l] maxim um to be e x- pected upper limit [µg/l] amidotrizoic acid 0,05 1 µg/l iodipamide 0,05 1 µg/l iohexol 0,05 1 µg/l iomeprol 0,05 1 µg/l iopamidol 0,05 1 µg/l Iopromide 0,05 1 µg/l iothalamic acid 0,05 1 µg/l ioxaglic acid 0,05 1 µg/l ioxitalamic acid 0,05 1 µg/l gadolinium 0,005 0,1 µg/l

The samples had to be analysed in duplicate over the complete method (sample preparation and measurement). Subcontracting of the analysis was not allowed.

The participants were asked to report the results as average values in µg/l and with three significant digits.

Submission of results The deadline for the submission of results was on 02 nd November 2015.

Evaluation procedure The statistical evaluation was executed according to DIN 38402-A45 and ISO TS 20612 “Interlaboratory comparisons for proficiency testing of analytical chemistry laboratories”. From the participants’ results a relative standard deviation was calculated for each concentration level and parameter using the Q-method. The reference values (see chapter “Traceable reference values”) were used as assigned values xa. The standard deviations resulting from the Q-method were used as σpt .

σpt was limited as follows:

• lower limit: 5% • upper limit: 25%

A z-score was calculated for each measurement result derived from the assigned value xa and the standard deviation for proficiency assessment σpt :

(x − x ) z − Score = pt ρ pt

The z-score was modified to a z U-score with a correction factor for proficiency assessment (as described in the standards mentioned above). The tolerance limit was defined as Iz UI=2.0.

PT 6/15 – TW S6 page 3

Assessment There was no overall assessment of the proficiency test round, but the single parameters were assessed. A parameter was assessed as successful, if more than half of the values were cor- rectly determined (2 out of 3 values are within the tolerance limits).

The single results will be assessed as follows: zu≤ 2 successful 2< zu< 3 questionable zu≥ 3 not successful

Not successful were: 1) Values outside the tolerance limit, 2) Values which were not determined (if the other samples of this parameters were analysed), 3) Values, which were indicated with “lower than limit of quantification”, 4) Values, which were subcontracted, 5) Values, which were submitted after the deadline of submission of results.

PT 6/15 – TW S6 page 4

Evaluation

Number of participants: 40

Number of reported values: 785

Number of accepted values: 663 (84,5%)

In the following figure the successful and not successful laboratories for each parameter are illustrated.

Explanation of Appendix A Appendix A contains for each parameter - parameter tables - a figure of participants’ means versus the spiked amounts for the determination of the recovery rate - a figure of the relative standard deviations versus the concentrations - a figure of the tolerance limits in the PT versus the concentrations - the frequency of application of analytical methods - the method specific evaluation - a comparison of mean and reference values for each concentration level - a comparison of the relative standard deviations of the different methods - the statistical characteristics of the method specific evaluation - a tabular comparison of the means with the reference values and their uncertainties

Parameter tables In these tables the following values for each concentration level are listed:

• assigned value • expanded uncertainty of the assigned value according the measurement uncertainty budget of the reference value determination PT 6/15 – TW S6 page 5

• standard deviation, calculated using robust statistical method • standard deviation for proficiency assessment for the calculation of z U-scores • rel. standard deviation for proficiency assessment • tolerance limits above and below • permitted deviations above and below in % • number of values in this level • number of not satisfactory values below and above the assigned value and the percentage of these values in total.

Determination of recovery rate In the diagrams of the assigned values versus the spiked amount of analyte a linear regression line was calculated using a generalized least square regression which takes into account the uncertainties of the values in both directions. From these values the recovery rate for each parameter was determined (see diagrams). The slope of the line indicates the average recovery rate. The diagrams also contain the expanded uncertainty (k=2) of the concentrations from the spike and the assigned values.

Relative standard deviations and tolerance limits The diagrams for the relative standard deviation vs. the assigned value show the concentration dependency of the standard deviation and the tolerance limits in per- cent. The relative standard deviations calculated from participants’ data are the stars connected by an interrupted line, the rel. standard deviation (and sometimes limited by the upper or lower limit) are given by squares, connected by a continuous line.

Method specific evaluation For each parameter the methods used by the participants are shown in a diagram. In a second diagram for each method with a frequency of more than 5 %, values are sorted in 5 categories: too low results with z U-score < -2 low results with –2 ≤ zU-score < –1 correct results with –1 ≤ zU-score ≤ +1 high results with +1 < z U-score ≤ +2 too high results with z U-score > +2

Comparison of means and reference values for each concentration level Finally the mean value calculated from all results, the reference value (see chapter Traceable reference values) are compared with mean values calculated for all methods separately. All mean values were calculated using the Hampel estimator described in ISO/TS 20612. Mean values were calculated only, if more than 8 results were within a z-score-range of ± 2. The means are reported with their expanded uncertainty, calculated according to ISO 13528. All mean values and their expanded uncertainties are additionally compared with the reference values and their expanded uncertainties.

Explanation of Appendix B Participants were asked to report expanded uncertainties of their results on a voluntary basis. In this diagram for each parameter the reported uncertainties for all concentration levels with the reproducibility standard deviation (horizontal line) are dis- played. Values which deviate from the reproducibility standard deviation with a factor more than 2 are usually not realistic. PT 6/15 – TW S6 page 6

Explanation of Appendix C In the last part of the report, for all concentration levels the results of all participants are illustrated. Confidentiality of participants is ensured by using lab codes. The lab codes were sent to participants with the certificates. In detail Appendix C contains: - a table with all data - figures with o all reported results o all z U-scores o all reported expanded uncertainties o all ζ− scores

Table with all data The assigned value with the expanded uncertainty and the tolerance limits for the concentration level is illustrated in the table. For each participant the following data are given:

• lab code • reported result • measurement uncertainty of the value (if reported) • ζ-score for this value, calculated with the following formula x − x ζ = pt , with u 2 + u 2 lab xpt − x xpt = difference from the measured value and the assigned value

• ulab = standard uncertainty of the value, reported by the participant • u = standard uncertainty of the assigned value xpt

• zU-score for proficiency assessment • assessment of the value according to its z-score

Meaning of ζ-scores: The assessment of ζ-scores is similar to that of z U-scores. If the data are normally distributed and the uncertainties are well estimated, ζ-scores will lie between -2 and +2 with a probability of around 95 %. ζ-scores are mainly influenced by the measurement uncertainties reported by the laboratory. Therefore ζ-scores are usually not appropriate for the assessment of the reported results, unless the reported measurement uncertainty is checked for fitness- for-purpose. Therefore we do not use the ζ-scores for the assessment of the laboratories. Nevertheless ζ-scores are appropriate to check the plausibility of the reported measurement uncertainty: If the z U-score of a result is within the tolerance limit and the ζ-score is outside, then the measurement uncertainty is underestimated. If the z U-score is outside the tolerance limits and the absolute value of the ζ-score is lower than two, then the requirements of the proficiency test were stronger compared with the reported measurement uncertainty.

PT 6/15 – TW S6 page 7

Diagrams of uncertainty data In the first figure for all lab codes the measurement uncertainty (together with the reproducibility standard deviation) is illustrated. The second figure shows the associat- ed ζ-scores.

Measurement uncertainty 17 (45,5%) out of 40 laboratories with valid values reported measurement uncertainties. In total 342 (43,6%) out of 785 valid values were given with the measurement uncertainty. The following table displays the number of values with measurement uncertainty against the accreditation status.

Accreditation status of Number of Number of values with meas- the values values urement uncertainty accredited 465 246 (52,9%) not accredited 107 54 (50,5%) not specified 213 42 (19,7%)

We would like to put emphasis on the fact that reporting of measurement uncertainties in our PT scheme is absolutely voluntary. The only objective is to help all participants to reasonably handle measurement uncertainties and their estimation. The diagrams show that the spread of reported uncertainties in some cases is vast, from unrealistic low values up to very high. A plausibility check using reproducibility standard deviations of the PT round could be helpful here. If measurement uncertainties are underestimated values assessed as “satisfactory” in the PT (|z U| ≤ 2), will have a large ζ-score. | ζ| > 2 means that the “own” requirements (defined in terms of estimated uncertainty) are not fulfilled. 70 (24,1%) of the 291 values reported with uncertainties and having a z U-score |z U| ≤ 2.0 had a ζ-score > 2.0. This means that the requirements of the PT scheme have been fulfilled , but not the “own” requirements, the uncertainty is underestimated.

Traceable reference values Traceability of analytical results to national and international references is of increas- ing importance in all laboratories. This is not easy to realise for chemical analyses and often can only be done by analysing certified reference materials. But availability of these reference materials in the water sector is very limited. Therefore we try to provide reference values for the proficiency test samples, traceable to national and international references. Since our PT samples without exception are spiked, real water samples, reference values can be calculated from the sum of matrix content and spiked amount of analyte. For both summands traceable values and their uncertainty have to be determined. Thereby we assume that no unrecognised bias resulting from sample preparation and transport is present and that we recognise all uncertainty components.

All spiking of samples was controlled gravimetrically and volumetrically. This procedure allows the preparation of a complete uncertainty budget. The first step is the specification of the measurand with a formula. This shows the links between the result and all influence quantities for the parameter.

PT 6/15 – TW S6 page 8

with: c concentration of the analyte in the lot resulting from the spike in g/l msubst mass of the subsance into the stock solution g Vss total volume of the stock solution in ml V1,Idil volume of stock solution added into the intermediate dilution in ml V2,Idil total volume of the intermediate dilution in ml V1,dil volume of intermediate dilution added into the dilution in ml V2,dil total volume of the dilution in ml V1,lot volume of the dilution added into the lot in ml mlot total mass of the lot in g ρlot density of the lot in g/l P purity of the used substance

Based on this formula the uncertainty budget can be prepared and all components can be quantified. The following figure shows a typical distribution of the contributions for iohexol.

The main uncertainty contributions resulted from the suppliers’ information for the uncertainty statement of the purity of the substance (purity: 97,4%, expanded uncertainty: 1%) as well as from the components resulted from the pipette steps.

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page A-11 of A-72 377:6

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page A-12 of A-72 377:6

ƌĞů͘ƐƚĂŶĚĂƌĚĚĞǀ͘ŵĞƚŚŽĚƐƉĞĐŝĨŝĐ ϯϵ ϯϴ ϯϳ ϯϲ ϯϱ ƌĞů͘ƐƚĂŶĚĂƌĚĚĞǀ͘ŝŶй ϯϰ ϯϯ ϭϮϯ ůĞǀĞů ŽǀĞƌĂůůŵĞĂŶ

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page A-14 of A-72 377:6

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page A-15 of A-72 377:6

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page A-16 of A-72 377:6

ŵĞĂŶŝŶђŐͬů Ϭ͕Ϭϰ Ϭ͕ϬϮ Ϭ ϭ ůĞǀĞů

page A-17 of A-72 377:6

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page A-18 of A-72 377:6

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page A-19 of A-72 377:6

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page A-21 of A-72 377:6

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page A-22 of A-72 377:6

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page A-23 of A-72 377:6

ŵĞĂŶŝŶђŐͬů Ϭ͕Ϭϰ Ϭ͕ϬϮ Ϭ ϭ ůĞǀĞů

page A-24 of A-72 377:6

page A-25 of A-72 377:6

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page A-26 of A-72 377:6

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page A-28 of A-72 377:6

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page A-29 of A-72 377:6

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page A-30 of A-72 377:6

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page A-31 of A-72 377:6

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page A-32 of A-72 377:6

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page A-33 of A-72 377:6

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page A-35 of A-72 377:6

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page A-36 of A-72 377:6

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page A-37 of A-72 377:6

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page A-38 of A-72 377:6

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page A-39 of A-72 377:6

page A-40 of A-72 377:6

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page A-42 of A-72 377:6

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page A-43 of A-72 377:6

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page A-45 of A-72 377:6

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page A-46 of A-72 377:6

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page A-47 of A-72 377:6

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page A-49 of A-72 377:6

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page A-50 of A-72 377:6

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page A-52 of A-72 377:6

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Ϭ ůĂďĐŽĚĞ

ŐĂĚŽŶůŝŶŝƵŵĂŶŽŵĂůǇͲ ϯ Ϯ͕ϱ Ϯ ϭ͕ϱ ϭ Ϭ͕ϱ Ϭ Ͳ^ĐŽƌĞ ] ͲϬ͕ϱ Ͳϭ Ͳϭ͕ϱ ͲϮ ͲϮ͕ϱ ůĂďĐŽĚĞ

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