BPA SMPR V 7

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Repeatability

Variation arising when all efforts are made to keep conditions constant by using the same instrument and operator, and repeating during a short time period. Expressed as the

repeatability standard deviation (SD r

); or % repeatability relative standard deviation

(%RSD r

).

Reproducibility

The standard deviation or relative standard deviation calculated from among-laboratory data. Expressed as the reproducibility relative standard deviation (SD R ); or % reproducibility

relative standard deviation (% RSD R ).

4. Method Performance Requirements:

Table 1

LOD

≤ 0.1 µg / liter

LOQ

≤ 0.5 µg / liter

Table 2 Analytical range*

< 2 µg / liter

2-5 µg / liter 80% - 120%

5-20 µg / liter 80% - 120%

Accuracy

60% - 140%

%RSD r

≤ 20%

≤ 10% ≤ 20%

≤ 5%

%RSD R

≤ 40%

≤ 10%

Units are expressed as µg / liter as weight / volume. *Concentration in the ready to drink product

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5. System suitability tests and/or analytical quality control:

Suitable methods will include blank check samples, and check standards at the lowest point

and midrange point of the analytical range.

6. Reference Material(s):

ANNEX F: Development and Use of In-House Reference Materials in Appendix F: Guidelines for Standard Method Performance Requirements in the Official Method of Analysis of the

AOAC INTERNATIONAL compendium.

7. Validation Guidance :

Method developers must submit data (LOQ, Accuracy…) on at least one of the matrices in Table 3. Data from as many of the other beverages listed in Table 3 would be desirable. It is

desirable to also have data on products containing coffee/dairy.

RSDRs may be calculated from pooled results from the different matrices in Table 3. Developers should submit the method’s procedures used for background assessment and

control, and frequency of analysis of method blanks.

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