Analytical Method Validation for residues determination in matrices from ecotoxicological tests

BioTecnologie BT carries out this method validation also for Plant Protection Products based on microorganims, for more information visit our Microbiology  Area.

Method set-up and optimisation are carried out by the suitable analytical equipment.

The analytical method validation consist of:
Linearity with  5 concentrations of analytical standard in the appropriate range of concentrations diluted with untreated matrix extract.
Recovery and Precision with 2 Fortification levels on the untreated matrix: LOQ and 10xLOQ (or other suitable level) with 5 samples for each level.
Acceptable ranges for the linearity, recovery and precision depend on the matrix and the fortification level.
Interferences check 2 samples of untreated blank to check interferences, analytical artifacts and matrix effects: the  analyte signal must be < 30% of LOQ where LOQ is defined as the low fortification level at which mean recovery and precision are acceptable.
LOD defined by Signal to Noise Ratio < 3.
Confirmatory analysis consists of additional MS/MS transition on:
– Linearity data (5 concentrations)
– Recovery and precision data at LOQ level (5  samples)
– Untreated blank data (2 samples)
If no additional transition is identified a confirmatory method is performed.
Additonally, the stability check of stock/working solutions and the stability check of the final extracts per matrix type can be carried out.
Study includes GLP managment and reporting.

SANCO/3029/99 rev. 4 (11/07/2000) – Residues: guidance for generating and reporting methods of analysis in support of pre-registration data requirements for Annex II (Part A, section 4) and Annex III (Part A, section 5) of Directive 91/414.
SANCO/825/00 rev. 8.1 (16/11/2010) – Guidance document on pesticide residue analytical methods.

DOWNLOAD SANCO/825/00 rev. 8.1 DOWNLOAD SANCO/3029/99 rev. 4

Study finder

Scientific Contact

Sabrina Mantilacci
Phone: +39 075 895 0045 – Ext. 268

Business Contact

Katy Lazzari
Phone: +39 075 895 0045 – Ext. 246

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