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Page 1: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

Page 2: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

Editorial improvements throughout the entire

document

1

Page 3: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

SANTE

11945/2015

New

SANTE/11813/2017

2

Page 4: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

SANTE 11945/2015

Residuals

New

SANTE/11813/2017

Back-calculated concentration

3

Page 5: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

SANTE/11945/2015

Residuals

Page 6: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

C trueC measured

Residual = (Cmeasured-Ctrue)x100/Ctrue

Page 7: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

Residual = (Ameasured-Atrue)x100/Atrue

measured

A true

A

Page 8: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

SANTE/11945/2015

Residuals

Glosary

Page 9: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

SANTE/11813/2017

Back-calculated concentration

Glosary

Page 10: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

SANTE/11945/2015

Identification requirements (for HRAMS)4

Page 11: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

SANTE/11813/2017

Identification requirements (for HRAMS)

MS detector/CharacteristicsAcquisition

Requirements for identification

ResolutionTypical systems

(examples)minimum

number of ionsother

Unit mass resolution

Single MS

quadrupole, ion trap, TOF

full scan, limited m/z range, SIM

3 ions

S/N ≥ 3d)

Analyte peaks from both product

ions in the extracted ion

chromatograms must fully overlap.

Ion ratio from sample extracts should be within ±30% (relative)

of average

of calibration standards from

same sequence

MS/MS

triple quadrupole, ion trap, Q-trap, Q-TOF, Q-Orbitrap

selected or multiple reaction monitoring (SRM, MRM), mass resolution for precursor-ion isolation equal to or better than unit mass resolution

2 product ions

Accurate massmeasurement

High resolution MS: (Q-)TOF(Q-)OrbitrapFT-ICR-MSsector MS

full scan, limited m/z range, SIM, fragmentation with or without precursor-ion selection, or combinations thereof

2 ions with mass accuracy ≤ 5 ppma, b, c)

S/N ≥ 3d)

Analyte peaks from precursor and/or product

ion(s) in the extracted ion

chromatograms must fully overlap.

Ion ratio: see D12

Page 12: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

SANTE/11945/2015 5

Page 13: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

SANTE/11813/2017

Identification requirements6

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EURLs Pesticide Residues

SANTE/11945/2015 - Calculation of results (Paragraph E3)

SANTE/11813/2017

Calculation of results (Paragraph E3)

7

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EURLs Pesticide Residues

SANTE/11945/2015

Method performance8

Page 16: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

SANTE/11813/2017

Method performance

Page 17: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

SANTE/11813/2017

Method performance9

Page 18: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

SANTE/11945/2015

Validation parameters and criteria10

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EURLs Pesticide Residues

SANTE/11813/2017

Page 20: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

SANTE/11945/2015

Annex A. Commodity groups and representative

commodities

11

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EURLs Pesticide Residues

SANTE/11813/2017

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EURLs Pesticide Residues

SANTE/11813/2017

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EURLs Pesticide Residues

12 SANTE/11813/2017

Glossary

Page 24: EURLs Pesticide Residues · EURLs Pesticide Residues SANTE/11813/2017 Identification requirements (for HRAMS) MS detector/Characteristics Acquisition Requirements for identification

EURLs Pesticide Residues

Thank you for your attention